EN    EN  
 EUROPEAN COMMISSION 
Brussels, 26.9.2012  
COM(2012) 542 final 
2012/0266 (COD) 
  
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on medical devices, and amending Directiv e 2001/83/EC, Regulation (EC) No 178/2002 
and Regulation (EC) No 1223/2009 
  
(Text with EEA relevance) 
{SWD(2012) 273 final} 
{SWD (2012 ) 274 final }   
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL 
The current EU regulatory framewor k for medical devices, other than in vitro  diagnostic 
medical devices, consists of Council Direc tive 90/385/EEC on active implantable medical 
devices (AIMDD)1 and Council Directive 93/42/EEC on medical devices (MDD)2 which 
cover a huge spectrum of products. The MDD divide s them into four classes of risk: class I 
(low risk, e.g. sticking plasters, corrective glas ses), class IIa (medium-low risk, e.g. tracheal 
tubes, dental filling material), class IIb (med ium-high risk, e.g. X-ray machines, bone plates 
and screws) and class III (high risk, e.g. heart valves, total hi p replacements, breast implants). 
Active implantable medical devices (e.g. pacemak ers, implantable defibrillators) covered by 
the AIMDD fall de facto  into class III.  
The two Directives, adopted in the 1990s, are ba sed on the ‘New Approach’ and aim to ensure 
the smooth functioning of the inte rnal market and a high level of  protection of human health 
and safety. Medical devices are not subject to any pre-market  authorisation by a regulatory 
authority but to a conformity  assessment which, for medium and high risk devices, involves 
an independent third party, know n as ‘notified body’. Notified  bodies, of which there are 
around 80 across Europe, are design ated and monitored by the Me mber States and act under 
the control of the national authorities. Once certified, devices bear  the CE marking which 
allows them to circulate freely in  the EU/EFTA countries and Turkey. 
The existing regulatory framework has demonstrat ed its merits but has also come under harsh 
criticism, in particular after the French hea lth authorities found that a French manufacturer 
(Poly Implant Prothèse , PIP) had for several years apparent ly used industrial silicone instead 
of medical grade silicone for the manufactur e of breast implants contrary to the approval 
issued by the notified body, causing harm to thousands of women around the world.  
In an internal market with  32 participating countries3 and subject to cons tant technological 
and scientific progress, substantial divergences in the interpretation and application of the rules have emerged, thus undermining the main object ives of the Directives, i.e. the safety of 
medical devices and their free movement with in the internal market. Moreover, regulatory 
gaps or uncertainties exist with regard to  certain products (e.g. products manufactured 
utilising non-viable human tissues or cells; implantable or other in vasive products for 
cosmetic purposes).  
This revision aims to overcome these flaws and gaps and to further strengthen patient safety. 
A robust, transparent and sustainable regulatory fr amework should be put in place that is ‘fit 
for purpose’. This framework should be suppor tive of innovation and the competitiveness of 
the medical device industry and should allo w rapid and cost-efficient market access for 
innovative medical devices, to the benefit of  patients and healthcare professionals. 
This proposal is adopted alongsid e a proposal for a Regulation on in vitro  diagnostic medical 
devices (IVDs), such as blood tests, whic h are covered by Direc tive 98/79/EC of the 
                                                
 
1 OJ L 189, 20.7.1990, p. 17. 
2 OJ L 169, 12.7.1993, p. 1. 
3 EU Member States, EFTA countries and Turkey.   
EN 3   EN European Parliament and of the Council (IVDD)4. The horizontal aspects that are common to 
both sectors are aligned whilst the specific features  of each sector require separate legal acts.  
2. RESULTS  OF CONSULTATIONS  WITH  INTERESTED  PARTIES  AND  
IMPACT  ASSESSMENTS 
In preparation for the impact assessment on this  proposal and the proposal for a Regulation on 
IVDs, the Commission held two public consultati ons, the first from 8 May to 2 July 2008, and 
the second from 29 June to 15 September 2010. In both public consultations, the general 
principles and minimum standards for consu ltation of interested parties by the Commission 
were applied; responses receiv ed within a reasonabl e period after the deadlines were taken 
into account. After analys ing all the responses, the Commission published a summary 
outcome and the individual responses on its website5. 
The majority of respondents to the 2008 public c onsultation (in particular Member States and 
industry) considered the propos ed revision to be premature.  They pointed to Directive 
2007/47/EC of the European Parliament and of the Council6, which amended the AIMDD and 
the MDD and was to be implemented by 21 Ma rch 2010, and also to the New Legislative 
Framework for the Marketing of Products which wa s due to enter into fo rce with effect from 
1 January 2010, and argued that it would be advisable to wait for these changes to be 
implemented, in order to assess the n eed for further adjustments better.  
The 2010 public consultation focussed on aspects related to the revision of the IVDD and 
showed wide support for this initiative, linked to  the revision of the regulatory framework for 
medical devices in general.  
During 2009, 2010 and 2011, the issues to be tack led in the revision of the regulatory 
framework for medical devices we re regularly discussed at mee tings of the Medical Devices 
Expert Group (MDEG), the Competent Auth orities for Medical Devices (CAMD) and 
specific working groups in the fields of notifie d bodies, borderline and cl assification, clinical 
investigation and evaluation, vigilance, market surveillance, in vitro  diagnostics medical 
devices (IVD) and in an ad hoc  working group on Unique Devi ce Identification (UDI). A 
special meeting of the MDEG was held on 31 March and 1 April 2011 to discuss issues 
related to the impact assessment. Moreover, th e Heads of Medicines Agencies (HMA) and the 
CAMD organised joint workshops on the devel opment of the legal framework for medical 
devices on 27 April and 28 September 2011.  
A further special meeting of the MDEG was held  on 6 and 13 February 2012 to discuss issues 
related to the two legislativ e proposals, based on working documents containing initial 
drafting proposals. Written comments made on these working documents were taken in account for the further development of the proposals.  
In addition, the Commission’s representatives regul arly participated in conferences to present 
ongoing work on the legislative initiative and hold  discussions with st akeholders. Targeted 
meetings took place at senior level with repr esentatives from associations representing 
industry, notified bodies, healthcar e professionals and patients.  
                                                
 
4 OJ L 331, 7.12.1998, p. 1. 
5 See http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm. 
6 OJ L 247, 21.9.2007, p. 21.  
EN 4   EN Aspects linked to the appropriate  regulatory framework were also  discussed in the course of 
the ‘Exploratory Process on the Future of the Medical Device Sector’ organised by the 
Commission from November 2009 to January 2010. On 22 March 2011, the Commission and the Hungarian Presidency organised a high -level conference on innovation in medical 
technology, the role of the medical device sect or in addressing the he althcare ch allenges 
facing Europe and the appropriate regulatory fram ework for this sector to meet the needs of 
tomorrow. This conference was followed by Conc lusions of the Council of the European 
Union on innovation in the medical de vice sector adopted on 6 June 2011
7. In its Conclusions, 
the Council requested the Commission to adapt th e EU medical device legi slation to the needs 
of tomorrow so as to achieve a suitable, ro bust, transparent and sustainable regulatory 
framework, which is central to fostering the development of safe, effective and innovative 
medical devices for the benefit of European  patients and health care professionals. 
Triggered by the PIP breast implants scandal, the European Parliament adopted on 14 June 
2012 a Resolution on defective silic one gel breast implants made by the French company PIP8 
also calling on the Commission to develop an adequate legal framework to guarantee the safety of medical technology. 
3. LEGAL
 ELEMENTS  OF THE  PROPOSAL 
3.1. Scope and definitions (Chapter I) 
The scope of the proposed Regulation corresponds to a large extent to the combined scopes of 
Council Directives 90/385/EEC a nd 93/42/EEC, i.e. it covers all medical devices other than in 
vitro  diagnostic medical devices. On the one hand, however, the scope is extended to some 
products currently not covered by the AIMDD/ MDD. And on the other hand, some products 
which, in some Member States, are placed on the market as medical devices are excluded 
from its scope.  
The extension of the scope concerns:  
• products manufactured utilis ing non-viable human tissues  or cells, or their 
derivatives, that have undergone substant ial manipulation (e.g. syringes prefilled 
with human collagen), unless they are c overed by Regulation (EC) No 1394/2007 on 
advanced therapy medicinal products9. Human tissues and cells, or products derived 
from human tissues or cells, that are no t substantially manipulated and that are 
regulated by Directive 2004/23/EC of the Eu ropean Parliament and of the Council of 
31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preserva tion, storage and distribution of human 
tissues and cells
10 are not covered by the proposal;  
• certain implantable or other invasive pr oducts without a medica l purpose that are 
similar to medical devices in terms of characteristics and risk profile (e.g. non-
corrective contact lenses, impl ants for aesthetic purposes); 
                                                 
7 OJ C 202, 8.7.2011, p. 7. 
8 Resolution of 14 June 2012 (2012/2621(RSP)); P7_TA-PROV(2012)0262, 
http://www.europarl.europa.eu/pl enary/en/texts-adopted.html. 
9 OJ L 324, 10.12.2007, p. 121. 
10 OJ L 102, 7.4.2004, p. 48.  
EN 5   EN Additional provisions as regard s products that are not covered by the Re gulation have been 
included, more to clarify the scope with a vi ew to ensuring harmonised implementation than 
to substantially change the scope of  the EU legislation. They concern: 
• products that contain or cons ist of viable biological substances (e.g. living micro-
organisms); 
• food covered by Regulation (EC) No 178/2002 on general principles and 
requirements of food law11 (e.g. this may affect certain slimming products); in return, 
medical devices are excluded from the scope of Regulation 178/2002 (diagnostic 
probes or cameras, even when introduced or ally, are therefore clearly excluded from 
the food legislation).  
As regards products composed of substances or combinations of substances that are intended 
to be ingested, inhaled or administered recta lly or vaginally and that are absorbed by or 
dispersed in the human body, the borderline be tween medicinal products and medical devices 
is difficult to draw. To ensure a high level of safety of those products regardless of their 
qualification, those products which fall under the definition of a medical device are classified 
in the highest risk class and should comply w ith the relevant requirements of Annex I of 
Directive 2001/83/EC of the European Parlia ment and of the Council of 6 November 2001 on 
the Community code relating to medicinal products for human use12. 
To support Member States and the Commission in determining the regulatory status of 
products, the Commission may set up, in accordance with its internal rules13, a group of 
experts from various sectors (such as medi cal devices, IVDs, medicinal products, human 
tissues and cells, cosmetics and biocides).  
The definitions section has been significantly extended, aligning th e definitions in the field of 
medical devices with well established European and international practice, such as the New Legislative Framework for the Marketing of Products
14 and guidance documents produced by 
the Global Harmonization Task Force (GHTF) for medical devices15. 
3.2. Making available of devices, obligations  of economic operators, reprocessing, 
CE marking, free movement (Chapter II) 
This chapter contains provisions that are typical  for product-related internal market legislation 
and sets out the obligations of the relevant economic operators (manufacturers, authorised 
representatives of non-EU ma nufacturers, importers and di stributors). The regulatory 
instrument of ‘common technical specification’ (CTS), which has proven useful in the context 
of the IVDD, has been introduced in the broa der field of medical devices to allow the 
Commission to further specify the general safe ty and performance requirements (laid down in 
                                                 
11 OJ L 31, 1.2.2002, p. 1.  
12 OJ L 311, 28.11.2001, p. 67. 
13 Communication from the President to the Commission of 10.11.2010, Framework for Commission 
Expert Groups: Horizontal Rules and Public Registers, C(2010)7649 final. 
14 Consisting of Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out 
the requirements for accreditation and market surveillance relating to the marketing of products and 
repealing Regulation (EEC) No 339/93, OJ L 218, 13.8.2008, p. 30, and Decision No 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products, 
and repealing Council Decision 93/465/EEC, OJ L 218, 13.8.2008, p. 82.  
15 http://www.ghtf.org/  
EN 6   EN Annex I) and the requirements on clinical evalua tion and post-market clinical follow-up (laid 
down in Annex XIII). Such re quirements however, leave manu facturers the possibility of 
adopting other solutions that ensure at least an  equivalent level of sa fety and performance. 
The legal obligations  on manufacturers are propo rtionate to the risk class of the devices they 
produce. For example, this means that even though all manufacturers should have a quality 
management system (QMS) in pl ace to ensure that their pr oducts consisten tly meet the 
regulatory requirements, the QMS-related respons ibilities are stricter for manufacturers of 
high risk devices than for manufacturers of low risk devices. Manufacturers of medical 
devices for an individual patie nt, so called ‘custom-made devices’, must ensure that their 
devices are safe and perform as intended, but their regulatory burden remains low. 
Key documents for the manufacturer to demonstrate compliance with the legal requirements 
are the technical documentation and the EU d eclaration of conformity to be drawn up in 
respect of devices placed on the market. Their minimum contents are laid down in Annexes II 
and III.  
The following concepts are also new in the field of medical devices:  
• A requirement has been introduced that within the manufacturer’s organisation a 
'qualified person' should be responsible for regulatory compliance. Similar 
requirements exist in EU legislation on me dicinal products and in the national laws 
transposing the AIMDD/MDD in some Member States.  
• Since in the case of 'parallel trade' with medical devices applica tion of the principle 
of free movement of goods varies consider ably from one Member State to another 
and, in many cases, de facto  prohibits this practice, clear conditions are set for 
enterprises involved in relabelling a nd/or repackaging medical devices. 
• Patients who are implanted with a device s hould be given essential information on 
the implanted device allowing it to be identified and containing any necessary 
warnings or precautions to be taken, for exam ple indication as to whether or not it is 
compatible with certain diagnostic devices  or with scanners used for security 
controls. 
• In accordance with Article 12a of the M DD, introduced by Directive 2007/47/EC, 
the Commission had to prepare a report on th e reprocessing of medical devices and 
submit, where appropriate, a legislative propo sal on this issue. On the basis of the 
Commission's findings set out in  its report of 27 August 201016, which took into 
account the opinion of the Scientific Co mmittee on Emerging and Newly Identified 
Health Risks (SCENIHR) of 15 April 2010, th e proposal contains strict rules on the 
reprocessing of single-use devices in order to ensure a high level of protection of 
health and safety whilst allowing this  practice to further develop under clear 
conditions. Reprocessing of si ngle-use devices is consider ed as manufacture of new 
devices so that the reprocessors must satisfy the obligations incumbent on 
manufacturers. The reproce ssing of single-use devices fo r critical use (e.g. devices 
                                                 
16 Report from the Commission to the European Parliament and the Council on the issue of reprocessing 
of medical devices in the Europ ean Union, in accordan ce with Article 12a of Directive 93/42/EEC, 
COM(2010)443 final.  
EN 7   EN for surgically invasive procedures) shoul d, as a general rule, be prohibited. Since 
certain Member States may have particular concerns in terms of safety regarding the 
reprocessing of single-use devices, they re tain their right to maintain or impose a 
general ban on this practice including the tr ansfer of single-use devices to another 
Member State or to a third country with a view to their reprocessing and on the 
access of reprocessed single-us e devices to their market. 
3.3. Identification and traceability of devi ces, registration of devices and economic 
operators, summary of safety and clinic al performance, Eudamed (Chapter III) 
This chapter addresses one of the main shortc omings of the current system: its lack of 
transparency. It consists of:  
• a requirement that economic operators must  be able to identify who supplied them 
and to whom they have supplied medical devices; 
• a requirement that manufacturers fit th eir devices with a Unique Device 
Identification (UDI) which allows traceabil ity. The UDI system will be implemented 
gradually and proportionate to th e risk class of the devices; 
• a requirement that manufacturers/authoris ed representatives and importers must 
register themselves and the devices they  place on the EU market in a central 
European database; 
• an obligation for manufactur ers of high-risk devices to  make publicly available a 
summary of safety and performance with key elements of the supporting clinical 
data;  
• and the further development of the European databank on medical devices 
(Eudamed), set up by Comm ission Decision 2010/227/EU17, which will contain 
integrated electronic systems on a European UDI, on registration of devices, relevant 
economic operators and cer tificates issued by notif ied bodies, on clinical 
investigations, on vigilan ce and on market surveillance. A large part of the 
information in Eudamed will become publicly available in accordance with the provisions regarding eac h electronic system.  
The establishment of a central registration database will not only provide a high level of 
transparency but also do away with diverging national registra tion requirements which have 
emerged over recent years and which have si gnificantly increased compliance costs for 
economic operators. It will ther efore also contribute to redu cing the administrative burden on 
manufacturers.  
3.4. Notified bodies (Chapter IV)  
Proper functioning of notified bodies is crucial fo r ensuring a high level of  health and safety 
protection and citizens' confiden ce in the system which has come under severe criticism in 
recent years due to significant differences as regards, on the one hand, the designation and monitoring of notified bodies a nd, on the other, the quality and depth of the conformity 
                                                
 
17 OJ L 102, 23.4.2010, p. 45.   
EN 8   EN assessment performed by them, in particular in their assessment of the manufacturers' clinical 
evaluation.  
In line with the New Legislative Framework for the Marketing of Products , the proposal sets 
out requirements for national aut horities responsible for notified bodies. It leaves  the ultimate 
responsibility for designating an d monitoring notified bodies, ba sed on stricter and detailed 
criteria laid down in Annex VI, with the indi vidual Member State. The proposal thus builds 
on existing structures already available in most Member States instead of lifting the 
responsibility to the Union level which might ha ve caused concerns in terms of subsidiarity. 
But any new designation and, in re gular intervals, the monitori ng of notified bodies are made 
subject to ‘joint assessments’ with experts from other Member Stat es and the Commission, 
thus ensuring an effective control at Union level.  
At the same time, the position of notified bodies  vis-à-vis manufacturer s will be significantly 
strengthened, including their ri ght and duty to carry out unan nounced factory inspections and 
to conduct physical or laboratory tests on devices . The proposal also requ ires rotation of the 
notified body's personnel involved in the asse ssment of medical devices at appropriate 
intervals to strike a reasona ble balance between the knowledge  and experience required to 
carry out thorough assessments and the need to en sure continuous objectiv ity and neutrality in 
relation to the manufacturer subject to those assessments. 
3.5. Classification and conformi ty assessment (Chapter V)  
The proposal keeps to the well established a pproach (in Europe and internationally) of 
dividing medical devices into four classes, taking account of the potential risks associated 
with the technical design and manufacture. Th e classification rules (l aid down in Annex VII) 
have been adapted to technical progress and experience gained from vigilance and market 
surveillance. For example, furt her to incidents that had occu rred to blood plasma donors and a 
request submitted by France, aphaeresis machines have been moved from class IIb to class III. 
Active implantable medical devices and their acce ssories have been classified in the highest 
risk class (class III) to mainta in the same level of safety as provided by Council Directive 
90/385/EEC.  
The classification of a medical device determ ines the applicable conformity assessment 
procedure for which the proposal follows th e general lines of the AIMDD/MDD. The 
conformity assessment procedure for class I devi ces can be carried out, as a general rule, 
under the sole responsibility of the manufacturer in view of th e low level of vulnerability 
associated with these products. However, when class I devices have a measuring function or 
are sold sterile, a notifie d body must verify the aspects relate d to the measuring function or to 
the sterilisation process. For devices of classe s IIa, IIb and III, an  appropriate level of 
involvement of a notified body is compulsory proportionate to the risk class, with devices of 
class III requiring explicit prior ap proval of the design or of the t ype of the device and of the 
quality management system before they may be  placed on the market. In the case of class IIa 
and IIb devices, the notified body checks the quality management system and, for 
representative samples, the t echnical documentation. After initi al certification, notified bodies 
must regularly conduct surveillance asse ssments in the post-market phase.  
The different conformity assessment procedures during which the notified body audits the 
manufacturer's quality management system, checks the technical documentation, examines 
the design dossier or approves the type of a devi ce are laid down in Annexes VIII to X. They 
have been tightened and streamlined. The proposa l reinforces the powers and responsibilities  
EN 9   EN of notified bodies and specifies the rules acco rding to which notified bodies perform their 
assessments, both in the pre-market and the post-market phase (e.g. documentation to be 
submitted, scope of the audit, unannounced factor y inspections, sample checks) to ensure a 
level playing field and avoid notified bodies being overly leni ent. Manufacturer s of custom-
made devices continue to be subject to a sp ecific procedure (laid down in Annex XI) which 
does not involve a notified body.  
In addition, the proposal intr oduces the obligation for notifie d bodies to notify an expert 
committee (see below under 3.8.) of new applicati ons for conformity as sessment of high-risk 
devices. On scientifically valid health grounds, the expert committee will have the power to 
request the notified body to submit a preliminary assessment on which the committee can issue comments within a deadline of 60 days
18, before the notified body can issue a certificate. 
This scrutiny mechanism empowers the author ities to have a 'second look' at individual 
assessments and make their views heard before  a device is placed on the market. A similar 
procedure is currently already applied for me dical devices manufactured utilising animal 
tissues (Commission Directive 2003/32/EC19). Its use should be the ex ception rather than the 
rule and should follow clear and transparent criteria.  
3.6. Clinical evaluation and clinical  investigations (Chapter VI)  
Building on the current Annex X of the MDD, th is chapter lays down the key obligations of 
manufacturers as regards the performance of the clinical evaluation needed to demonstrate the 
safety and performance of their devices. More de tailed requirements are set out in Annex XIII 
which addresses the pre-market clinical evalua tion and post-market clinical follow-up that 
together constitute a continuous process dur ing the life cycle of  a medical device. 
The process for conducting clinical investigations (t he equivalent of clini cal trials in the field 
of medicinal products), which is currently descri bed in basic terms in Article 15 of the MDD, 
is further developed. First of all, the concept of ‘sponsor’ is introduced  and aligned with the 
definition used in the recent Commission's Proposal for a Regulation of the European 
Parliament and of the Council on clinical trials on medicina l products for human use which 
aims at repealing Directive 2001/20/EC20. 
The sponsor can be the manufacturer, his authoris ed representative or another organisation, in 
practice often a ‘contract resear ch organisation’ conducting clin ical investigations for the 
manufacturers. The scope of the proposal, however, remains restricted to clinical 
investigations carried out for re gulatory purposes, i.e. for ob taining or confirming regulatory 
approval for market access. Non-commercial c linical investigations that do not pursue a 
regulatory purpose are not covered by this Regulation. 
In accordance with recognised inte rnational ethical principles, every clinical investigation 
must be registered in a publicly accessible el ectronic system which the Commission will set 
up. To ensure synergies with th e area of clinical trials on me dicinal products, the electronic 
system on clinical investigations  on medical devices should be interoperable with the future 
                                                 
18 In accordance with Article 3(3) of Regulation (EEC, EURATOM) No 1182/71 of the Council of 3 June 
1971 determining the rules applicable to periods, dates and time limits, OJ L 124, 8.6.1971, p. 1) days 
referred to in this Regu lation mean calendar days. 
19 OJ L 105, 26.4.2003, p. 18. This directive w ill be replaced by Commi ssion Regulation (EU) No 
722/2012 (OJ L 212, 9.8.2012, p. 3) with effect from 29 August 2013.  
20 COM(2012)369.  
EN 10   EN EU database to be set up in accordance with the future Regulation on clinical trials on 
medicinal products for human use.  
Before commencing a clinical investigation, the sponsor must submit an application to 
confirm that there are no health and safety or ethical aspects which would oppose it. A new 
possibility will be opened up for sponsors of clin ical investigations to be conducted in more 
than one Member State: in future, they may submit a single application through the electronic 
system to be set up by the Commission. As a consequence, the health and safety aspects regarding the device intended for clinical investig ation will be assessed by the Member States 
concerned under the direction of a coordinating Member State. Th e assessment of intrinsically 
national, local and ethical as pects (e.g. liability, suitability  of the investigators and 
investigation sites, informed cons ent) will, however, need to be ca rried out at the level of each 
Member State concerned which will retain the ul timate responsibility fo r deciding whether the 
clinical investigation may be conducted on its  territory. In line w ith the above-mentioned 
Commission's Proposal for a Regulation on clini cal trials on medicina l products, also this 
proposal leaves it to the Member States to define the organisati onal set-up at national level for 
the approval of clinical inves tigations. In other words, it moves away from a legally required 
dualism of two distinct bodies, i.e. a national competent authority and an ethics committee. 
3.7. Vigilance and market surveillance (Chapter VII)  
A well functioning vigilance system is the 'backbone ' of a robust regulatory framework in this 
sector because complications with medical devi ces that are designed to be implanted or to 
operate for many years or even decades might come to light only afte r a certain period of 
time. The main progress which the proposal will br ing in this field is the introduction of an 
EU portal where manufacturers must report seriou s incidents and corrective actions they have 
taken to reduce the risk of recurrence. The info rmation will be automatically forwarded to the 
national authorities con cerned. Where the same or similar in cidents have occurred, or where a 
corrective action has to be taken, in more than  one Member State, a coordinating authority 
will take the direction in coordinating the anal ysis of the case. The emphasis is placed on 
work- and expertise-sharing to avoid in efficient duplication of procedures.  
As regards market surveillance, the main objectiv es of the proposal are to reinforce the rights 
and obligations of the national competent authoritie s, to ensure effective coordination of their 
market surveillance activities and to clarify the applicable procedures. 
3.8. Governance (Chapters VIII and IX)  
The Member States will be responsible for impl ementation of the future Regulation. A central 
role in achieving harmonised interpretation and practice will be assigned to an expert 
committee (the Medical Devi ce Coordination Group or MDCG) made up of members 
appointed by the Member States due to their role and experience in the field of medical 
devices and chaired by the Commission. The MDCG  and its subgroups will allow to build a 
forum for discussions with stakeholders. The pro posal creates the legal basis that for specific 
hazards or technologies EU refere nce laboratories, a c oncept that has proven  successful in the 
food sector, may in the future be designated by the Commission. 
As regards the management at EU level, the im pact assessment identified as preferred policy 
options either the extension of the responsibil ity of the European Medicines Agency (EMA) 
to medical devices or the management of the medical devices re gulatory system by the 
Commission. Taking into account the clear pref erence expressed by stakeholders, including  
EN 11   EN many Member States, the proposal mandates the Commission to provide t echnical, scientific 
and logistic support to the MDCG. 
3.9. Final provisions (Chapter X)  
The proposal empowers the Commission to adopt , where appropriate, either implementing 
acts to ensure uniform applica tion of the Regulation or delegated acts to complement the 
regulatory framework for medical devices over time. 
With this proposal, other Union legislation is  amended where a link exists with medical 
devices. In the case of medicinal product/medi cal device combination products that are 
regulated under Directive 2001/83 /EC, the AIMDD and MDD alre ady require the device part 
to comply with the applicable essential requirements set out in the medical device legislation. 
However, compliance with this requirement is  not currently verified as part of the 
authorisation process for the medicinal product.  Annex I of Directive 2001/83/EC, which lays 
down the content of an applic ation for marketing authorisat ion, is therefore amended to 
require the applicant to submit ev idence (e.g. an EU declaration of  conformity or a certificate 
issued by a notified body)  that the device part is in conformity with the applicable general 
safety and performance requirements of th e future Regulation on medical devices.  
Regulation (EC) No 1223/2009 of the Europ ean Parliament and of the Council of 30 
November 2009 on cosmetic products21 is amended to empower the Commission to determine 
whether or not a product falls within the defini tion of a cosmetic product. Such possibility 
already exists in the AIMDD and the MDD and is kept in this proposal. It also exists in the new Regulation (EU) No 528/2012 of the European  Parliament and of the Council of 22 May 
2012 concerning the making available on the market and use of biocidal products
22. This will 
facilitate the adoption of EU-wide decisions re garding 'borderline' cases where the regulatory 
status of a product needs to be clarified. 
The Food Regulation 178/2002 is amended to excl ude medical devices from its scope (see 
3.1. above).  
The new Regulation will become applicable thr ee years after its entry into force to allow 
manufacturers, notified bodies a nd Member States time to adapt to the new requirements. The 
Commission needs time to put in place the IT infrastructure and the organisational arrangements necessary for the functioning of the new regulatory system. The designation of 
notified bodies pursuant to the new requirements and process needs to start shortly after the 
entry into force of the Regulation in order to ensure that by the date of its application, 
sufficient notified bodies are designated in a ccordance with the new rules to avoid any 
shortage of medical devices on the market. Special  transitional provisions are foreseen for the 
registration of medical devices,  relevant economic operators and certificates issued by 
notified bodies to allow for a smooth transitio n from registration requ irements at national 
level to a central registration at EU level. 
The future Regulation replaces and repeals Council Directives 90/385/EEC and 93/42/EEC.  
                                                
 
21 OJ L 342, 22.12.2009, p. 59.  
22 OJ L 167, 27.6.2012, p.1.   
EN 12   EN 3.10. Union competence, subsidiarity and legal form  
The proposal has a ‘double legal basis‘, i.e. Article 114 and Artic le 168(4)(c) of the Treaty on 
the Functioning of the European Union (TFEU) . With the entry into force of the Lisbon 
Treaty, the legal base for the establishment a nd functioning of the inte rnal market, on which 
the current Medical Devi ces Directives were adopted, has been complemented by a specific 
legal basis to set high standard s for the quality and safety of  devices for medical use. In 
regulating medical devices, the Union is exercisi ng its shared powers under  Article 4(2) of the 
TFEU.  
Under the current Medical Devices Directives, devices that bear the CE marking can, in 
principle, move freely within the EU. The propos ed revision of the existing directives, which 
will integrate the changes introduced by the Li sbon Treaty regarding public health, can be 
achieved only at Union level. This is necessary in order to improve the level of protection of 
public health for all European patients and user s, and also to prevent Member States from 
adopting diverging product regulations which w ould result in further fragmentation of the 
internal market. Harmonised rules and proced ures allow manufacturer s, especially SMEs 
which make up more than 80% of the sector, to  reduce costs related to national regulatory 
differences, while ensuring a hi gh and equal level of safe ty throughout the Union. In 
accordance with the principles of proportionality a nd subsidiarity, as set out  in Article 5 of the 
Treaty on European Union, this proposal does not go beyond what is necessary in order to achieve those objectives.  
The proposal takes the form of a Regulation. This  is the appropriate le gal instrument as it 
imposes clear and detailed rules which will become applicable in a uniform manner and at the same time throughout the Union. Diverging tr ansposition of the AIMDD and MDD by 
Member States has led to differe nt levels of health and safety  protection and cr eated obstacles 
to the internal market which only a Regulati on can avoid. Replacing the national transposition 
measures also has a strong simplification eff ect since it allows economic operators to conduct 
their business on the basis of a single regulatory framework, ra ther than a 'patchwork' of 27 
national laws. 
The choice of a Regulation, however, does not mean that decision-making is centralised. 
Member States retain their competence for impl ementing the harmonised rules, e.g. as regards 
approval of clinical investigations, the design ation of notified bodies,  the assessment of 
vigilance cases, the conduct of market survei llance and enforcement ac tion (e.g. penalties).  
3.11. Fundamental Rights 
In line with the Charter of Fundamental Rights of the EU, th is proposal seeks to ensure a high 
level of human health protecti on (Article 35 of the Charter) an d consumer protection (Article 
38) by assuring a high level of sa fety of medical devices made available on the Union market. 
The proposal affects the freedom of economic ope rators to conduct busin ess (Article 16) but 
the obligations imposed on manu facturers, authorised repr esentatives, importers and 
distributors of medical devices are necessary to guarantee a high level of safety of those 
products.  
The proposal sets guarantees for the protectio n of personal data. In respect to medical 
research, the proposal requires th at any clinical investigation with participation of human 
subjects is conducted respecting the human dignit y, the right to physical and mental integrity  
EN 13   EN of the persons concerned and the principle of free and informed consent, as required by 
Articles 1, 3(1) and 3(2)(a) of the Charter. 
4. BUDGETARY  IMPLICATIONS 
The budgetary implications of this proposal are as follows: 
• Costs for the further development of the Eudamed databank (one-off costs and 
maintenance); 
• Commission staff to organise and participate in 'joint assessments' of notified bodies;  
• Costs for national assessors pa rticipating in 'joint assessm ents' of notified bodies in 
accordance with the Commission's rules on the reimbursement of expenses incurred by experts; 
• Commission staff to provide scientific, t echnical and logistic support to the MDCG, 
to its sub-groups and to the coordinating Member States in  the fields of clinical 
investigations and vigilance; 
• Commission staff to manage and further develop the EU  regulatory framework for 
medical devices (functioning of th is Regulation and preparation of 
delegated/implementing acts) and to support Me mber States in ensuring its effective 
and efficient implementation; 
• Costs for organising meetings of the MDCG and its sub-groups and of the 
Committee under Regulation 182/2011, including reimbursement of their members, 
appointed by the Member States, to ensu re a high level of coordination between 
Member States; 
• Costs for the establishment and management of the scrutiny mechanism in respect of 
conformity assessments by notified bodies for high risk devices, including the 
technical infrastructure for data-exchange;  
• Costs for running EU reference laboratories when these are designated;  
• Costs for participation in intern ational regulatory  cooperation.  
Details of the costs are set out in the legislative financial st atement. A thorough discussion on 
the costs is contained in the impact assessment report.  
EN 14   EN 2012/0266 (COD) 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on medical devices, and amending Directiv e 2001/83/EC, Regulation (EC) No 178/2002 
and Regulation (EC) No 1223/2009 
  
(Text with EEA relevance) 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Article 114 and Article  168(4)(c) thereof, 
Having regard to the proposal from the European Commission, 
After transmission of the draft legislative act to the national Parliaments, Having regard to the opinion of the Eu ropean Economic and Social Committee
23,  
Having regard to the opinion of  the Committee of the Regions24,  
After consulting the European  Data Protection Supervisor25, 
Acting in accordance with the or dinary legislative procedure, 
Whereas: 
(1) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of 
the Member States relating to active implantable medical devices26 and Council 
Directive 93/42/EEC of 14 June 1993 concerning medical devices27 constitute the 
Union regulatory framework for medical devices, other than in vitro  diagnostic 
medical devices. However, a fundamental revi sion of those Directives is needed to 
establish a robust, transparent, predictabl e and sustainable regulatory framework for 
medical devices which ensures a high level of safety and health whilst supporting 
innovation. 
                                                 
23 OJ C […], […], p. […]. 
24 OJ C […], […], p. […]. 
25 OJ C […], […], p. […]. 
26 OJ L 189, 20.7.1990, p. 17.  
27 OJ L 169, 12.7.1993, p. 1.  
EN 15   EN (2) This Regulation aims to ensure the functio ning of the internal market as regards 
medical devices, taking as a base a high level of protection of health. At the same time, 
this Regulation sets high standards of quality and safety for medical devices to meet common safety concerns as regards these pr oducts. Both objectiv es are being pursued 
simultaneously and are inseparably linked whil st one not being sec ondary to the other. 
As regards Article 114 TFEU, this Regulatio n harmonises the rules for the placing on 
the market and putting into service of me dical devices and their accessories on the 
Union market which may then benefit from  the principle of free movement of goods. 
As regards Article 168(4)(c) TFEU, this Regul ation sets high sta ndards of quality and 
safety for those medical devices by ensuri ng, among other things, that data generated 
in clinical investigations is  reliable and robust and that the safety of the subjects 
participating in a clinical investigation is protected. 
(3) Key elements of the existing regulatory appr oach, such as the s upervision of notified 
bodies, conformity assessment procedures, clinical investiga tions and clinical 
evaluation, vigilance and market surveillance should be significantly reinforced, whilst 
provisions ensuring transp arency and traceab ility regarding devices should be 
introduced, to improve health and safety.  
(4) To the extent possible, guidance developed fo r medical devices at international level, 
in particular in the context of the Globa l Harmonization Task Force (GHTF) and its 
follow-up initiative the International Medi cal Devices Regulator s Forum, should be 
taken into account to promote the global c onvergence of regulations which contributes 
to a high level of safety protection worldwide an d to facilitate trade, in particular in the 
provisions on Unique Device Identificatio n, general safety and performance 
requirements, technical documentation, classi fication criteria, conformity assessment 
procedures and clini cal investigations.  
(5) For historic reasons active implantable medical devices, covered by Directive 
90/385/EEC, and other medical devices, co vered by Directive 93/42/EEC, were 
regulated in two separate legal instrument s. In the interest of simplification, both 
directives, which have been amended seve ral times, should be replaced by a single 
legislative act applicable to all medical devices other than in vitro  diagnostic medical 
devices. 
(6) A Regulation is the appropriate legal instrument as it imposes clear and detailed rules 
which do not give room for divergent tr ansposition by Member States. Moreover, a 
Regulation ensures that legal requiremen ts are implemented at the same time 
throughout the Union.  
(7) The scope of application of this Regula tion should be clearly delimited from other 
Union harmonisation legislation concerning products, such as in vitro  diagnostic 
medical devices, medicinal products, cosme tics and food. Therefore, Regulation (EC) 
No 178/2002 of the European Parliament a nd of the Council of 28 January 2002 laying 
down the general principles and requirements  of food law, establishing the European 
Food Safety Authority and laying down pr ocedures in matters of food safety
28 should 
be amended to exclude medical devices from its scope. 
                                                 
28 OJ L 31, 1.2.2002, p.1.  
EN 16   EN (8) It should be the responsibility of the Memb er States to decide on a case-by-case basis 
whether or not a product falls within the scope of this Regulation. If necessary, the 
Commission may decide, on a case-by-case basis,  whether or not a product falls within 
the definition of a medical device or of an accessory to a medical device. Since in 
some cases it is difficult to distinguish  between medical devices and cosmetic 
products, the possibility to ta ke an EU-wide decision regard ing the regulatory status of 
a product should also be introduced in Regulation No 1223/2009 of the European 
Parliament and of the Council of 30 November 2009 on cosmetic products29.  
(9) Products which combine a medicinal product or substance and a medical device, are 
regulated either under this Regulation or under Directive 2001/83/EC  of the European 
Parliament and of the Council of 6 Novemb er 2001 on the Community code relating to 
medicinal products for human use30. It should be ensured that  appropriate interaction 
exists between the two legislative acts in terms of consultations during the pre-market 
assessment and exchange of informa tion on vigilance cases occurring with 
combination products. For medicinal products  that integrate a medical device part, 
compliance with the general safety and pe rformance requirements of the device part 
should be adequately assessed in the context of the marketing authorisation. Directive 
2001/83/EC should therefore be amended. 
(10) Union legislation is incomplete in respect  of certain products manufactured utilising 
non-viable human tissues or cells that ha ve undergone substantial manipulation and 
that are not covered by Regulation (EC) No 1394/2007 of the European Parliament 
and of the Council of 13 November 2007 on a dvanced therapy medicinal products and 
amending Directive 2001/83/EC and Regulation (EC) No 726/200431. Whilst 
donation, procurement and testing of the human tissues and ce lls used for the 
manufacture of those products should re main within the scope of Directive 
2004/23/EC of the European Parliament a nd of the Council of 31 March 2004 on 
setting standards of quality and safety  for the donation, procurement, testing, 
processing, preservation, st orage and distribution of  human tissues and cells32, the 
finished product should come under the sc ope of this Regulation. Human tissues and 
cells that are not substantially manipulate d, such as human demineralised bone matrix, 
and products derived from such tissues a nd cells, should not be covered by this 
Regulation. 
(11) Certain implantable and othe r invasive products for whic h the manufacturer claims 
only an aesthetic or another non-medical purpose but which are similar to medical 
devices in terms of functioni ng and risks profile should be covered by this Regulation.  
(12) Like for products that contai n viable tissues or cells of human or animal origin, that 
are explicitly excluded from Directives  90/385/EEC and 93/42/EEC and hence from 
this Regulation, it should be clarified that products th at contain liv ing biological 
substances of other origin are al so not covered by this Regulation. 
(13) There is scientific uncertaint y about the risks and benefits  of nanomaterials used for 
medical devices. In order to en sure a high level of health pr otection, free movement of 
                                                 
29 OJ L 342, 22.12.2009, p. 59. 
30 OJ L 311, 28.11.2001, p. 67. 
31 OJ L 324, 10.12.2007, p. 121. 
32 OJ L 102, 7.4.2004, p. 48.  
EN 17   EN goods and legal certainty for manufacturers, it is necessary to introduce a uniform 
definition for nanomaterials based on  Commission Recommenda tion 2011/696/EU of 
18 October 2011 on the defi nition of nanomaterial33, with the necessary flexibility to 
adapt this definition to scientific and t echnical progress and subsequent regulatory 
development at Union and international level. In the design and manufacture of 
medical devices, the manufacturers should ta ke special care when using nanoparticles 
that can be released to the human body and t hose devices should be subject to the most 
severe conformity assessment procedure. 
(14) Aspects addressed by Directive 2004/108/EC of  the European Parliament and of the 
Council of 15 December 2004 on the approximati on of the laws of the Member States 
relating to electromagnetic compatibili ty and repealing Directive 89/336/EEC34 and 
aspects addressed by Directive 2006/42/EC of  the European Parliament and of the 
Council of 17 May 2006 on machinery and amending Directive 95/16/EC35 are an 
integral part of the general safety and pe rformance requirements for medical devices. 
Consequently, this Regulation should be considered a lex specialis  in relation to those 
Directives.  
(15) This Regulation should include requirements  regarding the design and manufacture of 
medical devices emitting ionizing radiati on without affecting the application of 
Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards 
for the protection of the health of workers and the general public against the dangers 
arising from ionising radiation36 nor of Council Directive 97/43/Euratom of 30 June 
1997 on health protection of individuals agai nst the dangers of ionizing radiation in 
relation to medical exposure and repealing Directive 84/466/Euratom37 which pursue 
other objectives.  
(16) It should be made clear th at the requirements of this Regulation also apply to the 
countries that have entered in to international agreements with the Union which confer 
on that country the same status as a Memb er State for the purpose of application of 
this Regulation, as it is currently the case with the Agreement on the European 
Economic Area38, the Agreement between the European Community and the Swiss 
Confederation on mutual recognition in relation to conformity assessment39 and the 
Agreement of 12 September 1963 establishing  an association between the European 
Economic Community and Turkey40.  
(17) It should be made clear that medical devices  offered to persons in the Union by means 
of information society services within the meaning of Directive 98/34/EC of the 
European Parliament and of the Council of 22 June 1998 laying down a procedure for 
the provision of information in the fiel d of technical stan dards and regulations41 as 
well as devices used in the context of a co mmercial activity to provide a diagnostic or 
                                                 
33 OJ L 275, 20.10.2011, p. 38. 
34 OJ L 390, 31.12.2004, p. 24 
35 OJ L 157, 9.6.2006, p. 24. 
36 OJ L 159, 29.6.1996, p. 1. 
37 OJ L 180, 9.7.1997, p. 22. 
38 OJ L 1, 3.1.1994, p. 3. 
39 OJ L 114, 30.4.2002, p. 369. 
40 OJ 217, 29.12.1964, p. 3687. 
41 OJ L 204, 21.7.1998, p. 37, as amended by Directive 98/48/EC of the European Parliament and of the 
Council of 20 July 1998, OJ L 217, 5.8.1998, p. 18.  
EN 18   EN therapeutic service to persons within the Un ion must comply with the requirements of 
this Regulation at the latest when the product is placed on the market or the service is 
provided in the Union. 
(18) It is appropriate to adapt the general safe ty and performance requirements to technical 
and scientific progress, for example for soft ware that is specifically intended by the 
manufacturer to be used for one or more  of the medical purposes set out in the 
definition of a medical device.  
(19) To recognise the important role of standa rdisation in the fiel d of medical devices, 
compliance with harmonised standards as defined in Regulation (EU) No […/…] on 
European standardisation42 should be a means for manufacturers to demonstrate 
conformity with the general safety and performance requirements and other legal 
requirements, such as qual ity and risk management. 
(20) Directive 98/79/EC of the European Parlia ment and of the Counc il of 27 October 1998 
on in vitro  diagnostic medical devices43 allows the Commission to adopt common 
technical specifications for specific categories of in vitro  diagnostic medical devices. 
In areas where no harmonised standards exis t or where they are not sufficient, the 
Commission should be empowered  to lay down technical spec ifications which provide 
a means to comply with general safety and performance requirements and 
requirements for clinical evaluation and/ or post-market clinical follow-up.  
(21) The definitions in the field of medical devices, for example regarding economic 
operators, clinical investigations and vigilance, should be aligned with well-
established practice at Union and internat ional level in order to enhance legal 
certainty. 
(22) The rules applicable to medical devices shou ld be aligned, where appropriate, with the 
New Legislative Framework for the Mark eting of Products, which consists of 
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 
2008 setting out the requirements for accredit ation and market surveillance relating to 
the marketing of products and repealing Regulation (EEC) No 339/9344 and Decision 
No 768/2008/EC of the European Parliament  and of the Council of 9 July 2008 on a 
common framework for the marketing of pr oducts, and repealing Council Decision 
93/465/EEC45.  
(23) The rules on Union market surveillance a nd control of products entering the Union 
market provided for in Regulation (EC) No 765/2008 apply to medical devices and 
their accessories covered by this Regulation which does not prevent Member States from choosing the competent authori ties to carry out those tasks.  
(24) It is appropriate to set out  clearly the general obligati ons of the different economic 
operators, including importers and distributors as laid dow n in the New Legislative 
Framework for the Marketing of Products, with out prejudice to the specific obligations 
laid down in the different parts of this  Regulation, to enhance understanding of the 
                                                
 
42 OJ L […], […], p. […]. 
43 OJ L 331, 7.12.1998, p. 1. 
44 OJ L 218, 13.8.2008, p. 30.  
45 OJ L 218, 13.8.2008, p. 82.  
EN 19   EN legal requirements and thus to improve regulatory compliance by the relevant 
operators. 
(25) Several of the obligations on manufacturers, such as clinical evaluation or vigilance 
reporting, that were set out only in th e annexes of Direc tives 90/385/EEC and 
93/42/EEC should be incorporated into the en acting provisions of this Regulation to 
enhance legal certainty. 
(26) To ensure that medical devices manufactured in series production continue to be in 
conformity with the requirements of this Regulation and that experience from the use 
of their medical devices is  taken into account for th e production process, all 
manufacturers should have a quality ma nagement system and a post-market 
surveillance plan in place which should be pr oportionate to the risk  class and the type 
of the medical device.  
(27) It should be ensured that supervision a nd control of the manufacture of medical 
devices is carried out within the manufactur er's organisation by a person who fulfils 
minimum conditions of qualification. 
(28) For manufacturers who are not established in the Union, the authorised representative 
plays a pivotal role in ensuring the comp liance of the medical devices produced by 
those manufacturers and in serving as their contact person established in the Union. 
The tasks of an authorised representative s hould be defined in a written mandate with 
the manufacturer which for example may allow the authorised representative to lodge an application for a conformity assessmen t procedure, to report events under the 
vigilance system or to re gister devices placed on the Union market. The mandate 
should empower the authorised representati ve to duly fulfil cert ain defined tasks. 
Considering the role of aut horised representatives, the minimum requirements to be 
met by them should be clearly defined, incl uding the requirement of having available a 
person who fulfils minimum conditions of qualification which should be similar to 
those for a manufacturer's qualified person but, with a view to the authorised 
representative's tasks, coul d also be satisfied by a pers on with qualification in law. 
(29) To ensure legal certainty in respect of th e obligations incumbent on economic 
operators, it is necessary to cl arify when a distributor, importer or other person is to be 
considered the manufacturer of a medical device. 
(30) Parallel trade in products already placed on th e market is a lawful form of trade within 
the internal market on the basis of Article 34 TFEU subject to the limitations set by the protection of health and safety and by the protection of intellect ual property rights 
provided by Article 36 TFEU. Application of this principle is, however, subject to 
different interpretations in the Member States. The conditions, in particular the 
requirements for relabelling and repackaging, should therefore be specified in this 
Regulation, taking into account the case-la w of the European Court of Justice
46 in 
other relevant sectors and existing good pract ices in the field of medical devices.  
(31) The findings of the Scientific Committee on Emerging and Newly Identified Health 
Risks (SCENIHR), established by Commi ssion Decision 2008/721/EC of 5 August 
                                                 
46 Judgment of the Court of 28 July 2011 in joined cases C-400/09 and C-207/10.  
EN 20   EN 2008 setting up an advisory structure of Scie ntific Committees and experts in the field 
of consumer safety, public health and the environment and repealing Decision 
2004/210/EC47, in its scientific opinion of 15 Ap ril 2010 on the safety of reprocessed 
medical devices marketed for single-use, and of the Commission in its report of 27 
August 2010 to the European Parliament a nd the Council on the issue of reprocessing 
of medical devices in the European Union, in  accordance with Article 12a of Directive 
93/42/EEC48, call for regulation of the reprocessing  of single-use devices in order to 
ensure a high level of protection of health  and safety whilst allowing this practice to 
further develop under clear conditions. By  reprocessing a single-use device its 
intended purpose is modified and the reproc essor should therefore be considered the 
manufacturer of the reprocessed device.  
(32) Patients who are implanted with a device shou ld be given essential information related 
to the implanted device allowing it to be  identified and containing any necessary 
warnings or precautions to be taken, for exam ple indications as to whether or not it is 
compatible with certain diagnostic devices or with scanners used for security controls.  
(33) Medical devices should, as a general rule, bear the CE marking to indicate their 
conformity with this Regulation so that th ey can move freely within the Union and be 
put into service in accordance with their intended purpose. Member States should not 
create obstacles to their pl acing on the market or putting into service for reasons 
related to the requirements la id down in this Regulation.  
(34) The traceability of medical devices by mean s of a Unique Device Identification (UDI) 
system based on international guidance shoul d significantly enhan ce the effectiveness 
of the post-market safety of medical devi ces due to improved incident reporting, 
targeted field safety corrective actions and better monitoring by co mpetent authorities. 
It should also help to reduce medical errors  and to fight against counterfeit devices. 
Use of the UDI system should also impr ove purchase-policy and stock-management 
by hospitals.  
(35) Transparency and better information are esse ntial to empower patients and healthcare 
professionals and to enable them to make informed decisions, to provide a sound basis 
for regulatory decision-making and to build  confidence in the regulatory system.  
(36) One key aspect is the creati on of a central database that  should integrate different 
electronic systems, with the UDI as an inte gral part of it, to collate and process 
information regarding medical devices on the market and the relevant economic 
operators, certificates, clinical investigati ons, vigilance and market surveillance. The 
objectives of the database are to enhan ce overall transparency, to streamline and 
facilitate the flow of information betw een economic operators, notified bodies or 
sponsors and Member States as well as between Member States among themselves and with the Commission, to avoid multiple repo rting requirements and to enhance the 
coordination between Member States. Within an internal market, this can be ensured 
effectively only at Union level and the Commission should theref ore further develop 
and manage the European databank on medical devices (Eudamed) set up by 
                                                
 
47 OJ L 241, 10.9.2008, p. 21. 
48 COM(2010)443 final.  
EN 21   EN Commission Decision 2010/227/EU of 19 Ap ril 2010 on the European Databank for 
Medical Devices49.  
(37) Eudamed's electronic systems regarding devi ces on the market, the relevant economic 
operators and certificates should enable the public to be adequately informed about 
devices on the Union market. The electronic system on clin ical investigations should 
serve as tool for the cooperation between Member States and fo r enabling sponsors to 
submit, on a voluntary basis, a single appli cation for several Member States and, in 
this case, to report serious adverse events . The electronic system on vigilance should 
enable manufacturers to report serious inci dents and other reporta ble events and to 
support the coordination of their assessmen t by national competen t authorities. The 
electronic system regarding market surveilla nce should be a tool for the exchange of 
information between competent authorities. 
(38) In respect of data collated and processed through the electronic systems of Eudamed, 
Directive 95/46/EC of the European Parlia ment and of the Counc il of 24 October 1995 
on the protection of individuals with regard to the processing of personal data and on 
the free movement of such data50 applies to the processing of personal data carried out 
in the Member States, under the supervis ion of the Member States competent 
authorities, in particular the public indepe ndent authorities designated by the Member 
States. Regulation (EC) No 45/2001 of the Eu ropean Parliament and of the Council of 
18 December 2000 on the protection of individua ls with regard to the processing of 
personal data by the Community institutions  and bodies and on the free movement of 
such data51 applies to the processing of persona l data carried out by the Commission 
within the framework of this Regulation, unde r the supervision of the European Data 
Protection Supervisor. In accordance with Article 2(d) of Regulation (EC) No 
45/2001, the Commission should be designated as the controller of Eudamed and its 
electronic systems. 
(39) For high-risk medical devices, manufacturer s should summarise the main safety and 
performance aspects of the device and the outcome of the clinic al evaluation in a 
document that should be publicly available. 
(40) The proper functioning of notified bodies is cr ucial for ensuring a high level of health 
and safety protection and citizens' c onfidence in the system. Designation and 
monitoring of notified bodies by the Member States, in a ccordance with detailed and 
strict criteria, should therefore be su bject to controls at Union level. 
(41) The position of notified bodi es vis-à-vis manuf acturers should be  strengthened, 
including their right and duty to carry out unannounced  factory inspections and to 
conduct physical or laboratory tests on medical devices to ensure continuous 
compliance by manufacturers after receipt  of the original  certification.  
(42) For high risk medical devices, authorities should be informed at an early stage about 
devices which are subject to conformity  assessment and be given the right, on 
scientifically valid grounds, to scrutinis e the preliminary assessment conducted by 
notified bodies, in particul ar regarding novel devices,  devices for which a novel 
                                                 
49 OJ L 102, 23.4.2010, p. 45.  
50 OJ L 281, 23.11.1995, p. 31. 
51 OJ L 8, 12.1.2001, p. 1.  
EN 22   EN technology is being used, devices belonging to  a category of devices with increased 
serious incident rates, or de vices for which significant disc repancies in the conformity 
assessments by different notified bodies have been identifie d in respect of 
substantially similar devices. The process fo reseen in this Regul ation does not prevent 
a manufacturer from informing voluntarily a competent authority of his intention to 
file an application for conformity assessm ent for a high risk medical device before 
submitting the application to the notified body. 
(43) It is necessary, in particular for the purpos e of the conformity assessment procedures, 
to maintain the division of medical devi ces into four product classes in line with 
international practice. The classification rule s, which are based on the vulnerability of 
the human body taking into account the potential risks associated with the technical design and manufacture of the devices, need to be adapted to technical progress and 
experience gained from vigilance and market surveillance. To maintain the same level of safety as provided by Directive 90/ 385/EEC, active implantable medical devices 
and their accessories should be in the highest risk class.  
(44) The conformity assessment procedure for cl ass I devices should be carried out, as a 
general rule, under the sole responsibility of the manufacturers in view of the low level 
of vulnerability associated with these products . For medical devices in classes IIa, IIb 
and III, an appropriate level of involvement  of a notified body should be compulsory, 
with medical devices in class III requiring explicit prior approval of their design and 
manufacture before they can  be placed on the market. 
(45) The conformity assessment procedures shou ld be simplified and streamlined whilst the 
requirements for notified bodies as regard s the performance of their assessments 
should be clearly specified to ensure a level playing field. 
(46) To ensure a high level of sa fety and performance, demons tration of compliance with 
the general safety and performance requireme nts should be based on clinical data that, 
for class III medical devices and implantabl e medical devices should, as a general rule, 
be sourced from clinical investigations to be carried out under th e responsibility of a 
sponsor who can be the manufacturer or another legal or na tural person taking 
responsibility for the clinical investigation. 
(47) The rules on clinical investigations should be  in line with major international guidance 
in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical investig ations of medical devices for human subjects and the most 
recent (2008) version of the World Medical  Association Declaration of Helsinki on 
Ethical Principles for Medical Research I nvolving Human Subjects to ensure that 
clinical investigations conducted in the Un ion are accepted elsewhere and that clinical 
investigations conducted outside the Union in  accordance with international guidelines 
can be accepted under this Regulation. 
(48) An electronic system should be set up at Un ion level to ensure that every clinical 
investigation is registered in a publicly acce ssible database. To protect the right to the 
protection of personal data, recognised by Article 8 of the Charter of Fundamental 
Rights of the European Union, no personal data  of subjects particip ating in a clinical 
investigation should be recorded in the electronic system . To ensure synergies with the 
area of clinical trials on medicinal pr oducts, the electronic system on clinical  
EN 23   EN investigations on medical devi ces should be interoperable w ith the EU database to be 
set up for clinical trials on me dicinal products for human use. 
(49) Sponsors of clinical investigations to be conducted in more than one Member State 
should be given the possibility to submit a single application in order to reduce 
administrative burden. In order to allow for resource-sharing and to ensure consistency 
regarding the assessment of the health and sa fety related aspects of the investigational 
device and of the scie ntific design of the clinical investigatio n to be conducted in 
several Member Stats, such single applic ation should facilitate the coordination 
between the Member States under the direct ion of a coordinating Member State. The 
coordinated assessment should not include th e assessment of intrinsically national, 
local and ethical aspects of a clinical inve stigation, including info rmed consent. Each 
Member State should retain the ultimate responsibility for deciding whether the clinical investigation may be conducted on its territory. 
(50) Sponsors should report certain a dverse events occurr ing during clinical  investigations 
to the Member States concerned, which should have the possibility to terminate or suspend the investigations if considered necessary to ensu re a high level of protection 
of the subjects enrolled in  a clinical investigation. Such information should be 
communicated to the other Member States. 
(51) This Regulation should only c over clinical investigations which pursue regulatory 
purposes laid down in this Regulation. 
(52) In order to better protect health and safety regarding devices on the market, the 
vigilance system for medical devices shoul d be made more e ffective by creating a 
central portal at Union level for reporting serious incidents and field safety corrective actions. 
(53) Healthcare professionals and patients should be empowered to repo rt suspected serious 
incidents at national level using harmonised formats. The national competent authorities should inform ma nufacturers and share the in formation with their peers 
when they confirm that a serious incident has occurred in order to minimise recurrence 
of those incidents. 
(54) The assessment of reported serious incidents and field safety corre ctive actions should 
be conducted at national level but coordination should be ensured where similar incidents have occurred or field safety corr ective actions have to be carried out in 
more than one Member State with the obje ctive of sharing resources and ensuring 
consistency regarding the corrective action. 
(55) The reporting of serious adverse events during clinical investigations and the reporting 
of serious incidents occurring after a medi cal device has been placed on the market 
should be clearly distinguis hed to avoid double reporting. 
(56) Rules on market surveillance should be included in this Regulation to reinforce the 
rights and obligations of the national comp etent authorities, to ensure effective 
coordination of their market surveillance ac tivities and to clarify the applicable 
procedures.   
EN 24   EN (57) The Member States shall levy fees for th e designation and monitoring of notified 
bodies to ensure sustainabil ity of the monitoring of those bodies by Member States 
and to establish a level playi ng field for notified bodies.  
(58) Whilst this Regulation should not affect the right of Member States to levy fees for 
activities at national level, Member Stat es should inform the Commission and the 
other Member States before they adopt the level and structure of the fees to ensure 
transparency. 
(59) An expert committee, the Medical Device Coordination Group (MDCG), composed of 
persons designated by the Member States base d on their role and e xpertise in the field 
of medical devices and in vitro  diagnostic medical devices should be established to 
fulfil the tasks conferred on it by this Re gulation and by Regula tion (EU) […/…] on in 
vitro  diagnostic medical devices52, to provide advice to th e Commission and to assist 
the Commission and the Member States in  ensuring a harmonised implementation of 
this Regulation. 
(60) Closer coordination between national comp etent authorities through information 
exchange and coordinated assessments under the direction of a c oordinating authority 
is fundamental for ensuring a consistently hi gh level of health and safety within the 
internal market, in particular in the areas of clinical inves tigations and vigilance. This 
should also lead to more efficient use of scarce resources at national level. 
(61) The Commission should provi de scientific, technical and corresponding logistic 
support to the coordinating nati onal authority and ensure that  the regulatory system for 
medical devices is effectively implemente d at Union level based on sound scientific 
evidence. 
(62) The Union should actively partic ipate in inte rnational regulatory cooperation in the 
field of medical devices to facilitate th e exchange of safety-related information 
regarding medical devices and to foster the further development of international 
regulatory guidelines promoting the adoption of  regulations in other jurisdictions with 
a level of health and safety protection e quivalent to that set by this Regulation.  
(63) This Regulation respects the fundamental ri ghts and observes the pr inciples recognised 
in particular by the Charter of Fundamental  Rights of the European Union and notably 
human dignity, the integrity of the person, th e protection of personal data, the freedom 
of art and science, the freedom to conduc t business and the right to property. This 
Regulation should be applied by the Member States in accordance with those rights 
and principles. 
(64) In order to maintain a high level of hea lth and safety, the power to adopt acts in 
accordance with Article 290 TFEU should be delegated to the Commission in respect 
of the products subject to this Regulation th at are similar to medical devices but do not 
necessarily have a medical pur pose; adaptation of the definition of nanomaterial to 
technical progress and to developments at Un ion and international level; adaptation to 
technical progress of th e general safety and performance requirements, of the elements 
to be addressed in the tec hnical documentation, of the minimum content of the EU 
                                                 
52 OJ L […], […], p. […].  
EN 25   EN declaration of conformity and of the certi ficates issued by notified bodies, of the 
minimum requirements to be met by notified bo dies, of the classification rules, of the 
conformity assessment procedures, and of the documentation to be submitted for the 
approval of clinical investigations; the establishment of the UDI system; the information to be submitted for the regi stration of medical devices and certain 
economic operators; the level and structure of fees for the designation and monitoring 
of notified bodies; the publicly available information in respect of clinical 
investigations; the adoption of  preventive health protection measures at EU level; and 
the tasks of and criteria for European Uni on reference laboratories and the level and 
structure of fees for scientif ic opinions delivered by them.  
It is of particular importance that the Co mmission carry out appropriate consultations 
during its preparatory work, including at  expert level. The Commission, when 
preparing and drawing up delegated acts, should ensure a simultaneous, timely and 
appropriate transmission of relevant documen ts to the European Parliament and to the 
Council. 
(65) In order to ensure uniform conditions fo r the implementation of this Regulation, 
implementing powers should be conferre d on the Commission. Those powers should 
be exercised in accordance with Regula tion (EU) No 182/2011 of the European 
Parliament and of the Council of 16 Februa ry 2011 laying down the rules and general 
principles concerning mechanisms for cont rol by Member States of the Commission's 
exercise of implementing powers
53.  
(66) The advisory procedure should be used for the adoption of the fo rm and presentation 
of the data elements of the manufactur ers' summary of safety and clinical 
performance; of the codes defining the notif ied bodies' scopes of designation; and of 
the model for certificates of fr ee sale, given that those acts have a procedural character 
and do not directly impact the heal th and safety at Union level. 
(67) The Commission should adopt immediately a pplicable implementing acts where, in 
duly justified cases relating to the extension to the territory of the Union of a national derogation from the applicable conformity a ssessment procedures in exceptional cases; 
relating to the Commission's position whether a provisional national measure against a 
medical device presenting a risk or a provi sional national preventive health protection 
measure is justified or not; and relating to  the adoption of a Union measure against a 
medical device presenting a risk, impera tive grounds of urgency so require.  
(68) To allow economic operators, notified bodies , Member States and the Commission to 
adapt to the changes introduced by this Regu lation, it is appropria te to provide for a 
sufficient transitional period for that adaptation and for the organisational 
arrangements to be taken for its proper applic ation. It is particular ly important that by 
the date of application, a sufficient num ber of notified bodies are designated in 
accordance with the new requirements to avoi d any shortage of medical devices on the 
market. 
(69) In order to ensure a smooth transition to the registration of medical devices, of 
relevant economic operators and of certifi cates, the obligation to  submit the relevant 
                                                
 
53 OJ L 55, 28.2.2011, p. 13.   
EN 26   EN information to the electronic systems put in  place by this Regula tion at Union level 
should become fully effective only 18 months after the date  of application of this 
Regulation. During this transi tional period, Article 10a and point (a) of Article 10b(1) 
of Directive 90/385/EEC and Article 14(1) an d (2) and points (a) and (b) of Article 
14a(1) of Directive 93/42/EEC  should remain in force. However, economic operators 
and notified bodies who regist er in the relevant electr onic systems provided for at 
Union level should be considered in comp liance with the registration requirements 
adopted by the Member States pursuant to t hose provisions of the Directives to avoid 
multiple registrations.  
(70) Directives 90/385/EEC and 93/42 /EEC should be repealed to  ensure that only one set 
of rules applies to the placing of medical de vices on the market and the related aspects 
covered by this Regulation.  
(71) Since the objective of this Regulation, namely to ensure high standards of quality and 
safety for medical devices, thus ensuring a hi gh level of protection of health and safety 
of patients, users and other persons, cannot  sufficiently be achieved by the Member 
States and can, by reason of the scale of the measure, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity 
as set out in Article 5 of the Treaty on European Union. In accordance with the 
principle of proportionality, as set out in that Article, this Regulation does not go 
beyond what is necessary in orde r to achieve that objective. 
HAVE ADOPTED THIS REGULATION:  
EN 27   EN Chapter I 
Scope and definitions 
Article 1 
Scope 
1. This Regulation establishes rules to be  complied with by medical devices and 
accessories to medical devices that are placed on the market or put into service in the 
Union for human use. 
For the purposes of this Regulation, medi cal devices and accessories to medical 
devices shall herein after be referred to as ‘devices’. 
2. This Regulation shall not apply to:  
(a) in vitro  diagnostic medical devices covered by Regulation (EU) […/…]; 
(b) medicinal products covered by Direc tive 2001/83/EC and advanced therapy 
medicinal products covered by Regul ation (EC) No 1394/2007. In deciding 
whether a product falls under Directiv e 2001/83/EC or Regulation (EC) No 
1394/2007 or under this Regulation, particul ar account shall be taken of the 
principal mode of action of the product; 
(c) human blood, blood products, plasma or bl ood cells of human origin or devices 
which incorporate, when placed on the mark et or used in accordance with the 
manufacturer's instructions, such bl ood products, plasma or  cells, except for 
devices referred to in paragraph 4; 
(d) cosmetic products covered by Regulation (EC) No 1223/2009; 
(e) transplants, tissues or cells of human or animal origin or th eir derivatives, or 
products containing or cons isting of them, unless a device is manufactured 
utilising tissues or cells of human or an imal origin, or their derivatives, which 
are non-viable or are rendered non-viable. 
However, human tissues and cells that  are non-viable or are rendered non-
viable and that have undergone only non- substantial manipulat ion, in particular 
those listed in Annex I of Regulation (EC) No 1394/2007, and products derived 
from such tissues and cells, shall not  be considered devices manufactured 
utilising tissues or cells of huma n origin or their derivatives;  
(f) products that contain or consist of bi ological substances or organisms other 
than those referred to in points (c) and (e) that are viable , including living 
micro-organisms, bacteria, fungi or virus; 
(g) food covered by Regulation (EC) No 178/2002.  
3. Any device which, when placed on the market or used in accordance with the 
manufacturer's instructions, incorporates as an integral part an in vitro  diagnostic  
EN 28   EN medical device as defined in Article  2 of Regulation (EU) […/...] [on in vitro  
diagnostic medical devices] shall be governed  by this Regulation, unless it is covered 
by Article 1(3) of that Regulation. The relevant general safety and performance 
requirements set out in Annex I of that Regulation shall apply as far as the safety and 
performance of the in vitro  diagnostic medical devi ce part are concerned.  
4. Where a device, when placed on the market or used in accordance with the 
manufacturer's instructions, incorporates, as an integral  part, a substance which, if 
used separately, would be considered to be  a medicinal product as defined in Article 
1(2) of Directive 2001/83/EC, including a medicinal product derived from human 
blood or human plasma as defined in Articl e 1(10) of that Directive, with action 
ancillary to that of the device, that de vice shall be assessed and authorised in 
accordance with this Regulation. 
However, if the action of the medicinal s ubstance is not ancillary to that of the 
device, the product shall be governed by Directive 2001/83/EC. In this case, the relevant general safety and performance requirements set out in Annex I of this 
Regulation shall apply as far as the safety  and performance of the device part are 
concerned. 
5. Where a device is intended to administer a medicinal product as defined in Article 
1(2) of Directive 2001/83/EC , that device shall be g overned by this Regulation, 
without prejudice to the pr ovisions of Directive 2001/83/ EC with regard to the 
medicinal product.  
However, if the device intended to admini ster a medicinal product and the medicinal 
product are placed on the market in such a way that they form a single integral 
product which is intended exclusively for us e in the given combin ation and which is 
not reusable, the product shall be governed by Directive 2001/83/EC. In this case, the 
relevant general safety and performance requirements set out in Annex I of this 
Regulation shall apply as far as the safety  and performance of the device part are 
concerned. 
6. This Regulation is a specific Union legislat ion within the meaning of Article 1(4) of 
Directive 2004/108/EC and with in the meaning of Article 3 of Directive 2006/42/EC. 
7. This Regulation shall not affect the app lication of Council Dire ctive 96/29/Euratom 
nor of Council Directive 97/43/Euratom. 
8. This Regulation shall not affect national la ws which require that certain devices may 
only be supplied on a medical prescription. 
9. References to a Member State in this Re gulation shall be understood as including any 
other country with which the Union has concluded an agreement which confers on 
that country the same status as a Member St ate for the purpose of application of this 
Regulation. 
Article 2 
Definitions 
1. For the purposes of this Regulation, th e following definitions shall apply:  
EN 29   EN Definitions related to devices: 
(1) ‘medical device’ means any instrument , apparatus, appliance, software, 
implant, reagent, material or other arti cle, intended by the manufacturer to be 
used, alone or in combination, for human beings for one or more of the specific 
medical purposes of:  
– diagnosis, prevention, monitorin g, treatment or alleviation of 
disease, 
– diagnosis, monitoring, treatment, alleviation of or compensation for 
an injury or disability, 
– investigation, replacement or modi fication of the anatomy or of a 
physiological process or state, 
– control or support of conception, 
– disinfection or sterilisation of any of the above-mentioned 
products,  
and which does not achieve its prin cipal intended action by pharmacological, 
immunological or metabolic means, in  or on the human body, but which may 
be assisted in its function by such means. 
The implantable or other invasive pr oducts, intended to be used for human 
beings, which are listed in Annex XV shall be considered medical devices, 
regardless of whether or not they are in tended by the manufacturer to be used 
for a medical purpose. 
(2) ‘accessory to a medical device’ means an article which, whilst not being a 
medical device, is intended by its manufactur er to be used together with one or 
several particular medical device(s) to spec ifically enable or assist the device(s) 
to be used in accordance with its/their intended purpose(s); 
(3) ‘custom-made device’ means any device sp ecifically made in accordance with 
a written prescription of a doc tor of medicine, of a dent al practitione r or of any 
other person authorised by national law by virtue of this person's professional 
qualifications which gives, under his responsibility, specific design 
characteristics, and is intended for th e sole use of a particular patient. 
 However, mass-produced devices which need to be adapted to meet the 
specific requirements of a doctor of medi cine, a dental practi tioner or any other 
professional user and devices which ar e mass-produced by means of industrial 
manufacturing processes in accordance with the written prescriptions of 
doctors of medicine, dental practitioners  or any other authorised person shall 
not be considered to be  custom-made devices; 
(4) ‘active device’ means any device, the operation of which depends on a source 
of electrical energy or any source of power  other than that directly generated 
by gravity and which acts by changing the density of or conv erting this energy. 
Devices intended to transmit energy, substances or other elements between an  
EN 30   EN active device and the patient, without any significant change, shall not be 
considered to be active devices.  
 Stand alone software shall be  considered an active device; 
(5) ‘implantable device’ means any device, including those that are partially or 
wholly absorbed, which is intended  
– to be totally introduced into the human body or 
– to replace an epithelial surface or the surface of the eye,  
 by clinical intervention and which is  intended to remain in place after the 
procedure.  
 Any device intended to be partially introduced into the human body by clinical 
intervention and intended to remain in place after the procedure for at least 30 days shall also be consider ed an implantable device; 
(6) ‘invasive device’ means any device whic h, in whole or in part, penetrates 
inside the body, either through a body or ifice or through the surface of the 
body; 
(7) ‘generic device group’ means a set of devices having the same or similar 
intended purposes or commonality of technology allowing them to be classified 
in a generic manner not reflecti ng specific characteristics;  
(8) ‘single-use device’ means a device that is  intended to be used on an individual 
patient during a single procedure. 
The single procedure may involve severa l uses or prolonged use on the same 
patient;  
(9) ‘single-use device for critical use’ mean s a single-use device  intended to be 
used for surgically inva sive medical procedures; 
(10) ‘intended purpose’ means the use for which the device is intended according to 
the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements; 
(11) ‘label’ means the written, printed, or graphic information appearing either on 
the device itself, or on the packaging of each unit or on the packaging of multiple devices; 
(12) ‘instructions for use’ means the info rmation provided by the manufacturer to 
inform the user of the device’s inte nded purpose and proper use and of any 
precautions to be taken; 
(13) ‘Unique Device Identification’ (‘UD I’) means a series of numeric or 
alphanumeric characters that is create d through internationally accepted device 
identification and coding standards and that allows unambiguous identification 
of specific devices on the market;  
EN 31   EN (14) ‘non-viable’ means having no potential  for metabolism or multiplication; 
(15) ‘nanomaterial’ means a natural, incident al or manufactured material containing 
particles, in an unbound state or as an aggregate or as an agglomerate and 
where, for 50 % or more of the particles in the number size di stribution, one or 
more external dimensions is in the size range  1-100 nm.  
 Fullerenes, graphene flakes and single -wall carbon nanotubes with one or more 
external dimensions below 1 nm sha ll be considered as nanomaterials.  
 For the purposes of the definition of nanomaterial, ‘particle’, ‘agglomerate’ 
and ‘aggregate’ are de fined as follows:  
– ‘particle’ means a minute piece of matter with defined physical 
boundaries;  
– ‘agglomerate’ means a collecti on of weakly bound particles or 
aggregates where the resulting extern al surface area is similar to the 
sum of the surface areas of the individual components;  
– ‘aggregate’ means a particle comp rising of strongly bound or fused 
particles;  
Definitions related to the making available of devices: 
(16) ‘making available on the market’ means any supply of a device, other than an 
investigational device, for distribu tion, consumption or use on the Union 
market in the course of a commercial ac tivity, whether in return for payment or 
free of charge;  
(17) ‘placing on the market’ means the first making available of a device, other than 
an investigational devi ce, on the Union market; 
(18) ‘putting into service’ means the stag e at which a device, other than an 
investigational device, has been made ava ilable to the final user as being ready 
for use on the Union market for the first time for its intended purpose;  
Definitions related to economic opera tors, users and specific processes: 
(19) ‘manufacturer’ means the natural or le gal person who manufactures or fully 
refurbishes a device or has a de vice designed, manufactured or fully 
refurbished, and markets that device under his name or trademark. 
For the purposes of the definition of manu facturer, fully refurbishing is defined 
as the complete rebuilding of a device al ready placed on the market or put into 
service, or the making of a new devi ce from used devices, to bring it in 
conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device; 
(20) ‘authorised representative ’ means any natural or legal person established 
within the Union who has received and accepted a written mandate from a  
EN 32   EN manufacturer to act on his behalf in rela tion to specified tasks with regard to 
the latter's obligations under this Regulation; 
(21) ‘importer’ means any natural or legal person established within the Union who 
places a device from a third country on the Union market; 
(22) ‘distributor’ means any natural or legal person in the supply chain, other than 
the manufacturer or the importer, who makes a device available on the market; 
(23) ‘economic operators’ means the manufact urer, the authorised representative, 
the importer and the distributor;  
(24) ‘health institution’ means an organisati on whose primary purpose is the care or 
treatment of patients or the promotion of public health; 
(25) ‘user’ means any healthcare professiona l or lay person who uses a device; 
(26) ‘lay person’ means an individual who does not have formal education in a 
relevant field of healthcare or medical discipline;  
(27) ‘reprocessing’ means the process carried ou t on a used device in order to allow 
its safe reuse including cleaning, disi nfection, sterilisation and related 
procedures, as well as testing and rest oration of the technical and functional 
safety of the used device;  
Definitions related to conformity assessment: (28) ‘conformity assessment’ means the process demonstrating whether the 
requirements of this Regulation relating to a device have been fulfilled;  
(29) ‘conformity assessment body’ means a body that performs third-party 
conformity assessment activities includi ng calibration, testing, certification and 
inspection;  
(30) ‘notified body’ means a conformity a ssessment body designat ed in accordance 
with this Regulation;  
(31) ‘CE marking of conformity’ or ‘CE ma rking’ means a marking by which the 
manufacturer indicates that the device is  in conformity with the applicable 
requirements set out in this Regul ation and other applicable Union 
harmonisation legislation pr oviding for its affixing; 
Definitions related to clinical eval uation and clinical investigations: 
(32) ‘clinical evaluation’ means the assessm ent and analysis of clinical data 
pertaining to a device in order to veri fy the safety and performance of the 
device when used as inte nded by the manufacturer; 
(33) ‘clinical investigation’ means any systematic investigation in one or more 
human subjects, undertaken to assess the safety or performance of a device;  
EN 33   EN (34) ‘investigational devi ce’ means any device being assessed for safety and/or 
performance in a clinic al investigation;  
(35) ‘clinical investigation plan’ means the document(s) setting out the rationale, 
objectives, design and proposed anal ysis, methodology, monitoring, conduct 
and record-keeping of the clinical investigation; 
(36) ‘clinical data’ means the information con cerning the safety or performance that 
is generated from the use of a device and that are sourced from the following: 
– clinical investigation(s) of  the device concerned,  
– clinical investigation(s) or other studies reported in the scientific 
literature, of a similar device for which equivalence to the device in question can be demonstrated,  
– published and/or unpublished reports on other clinical experience 
of either the device in question or a similar device for which equivalence to the device in question can be demonstrated; 
(37) ‘sponsor’ means an individual, compa ny, institution or organisation which 
takes responsibility for the initiation and management of a clinical investigation; 
(38) ‘adverse event’ means any untoward medical occurrence,  unintended disease or 
injury or any untoward clinical si gns, including an abnormal laboratory 
finding, in subjects, users or other pe rsons, in the context of a clinical 
investigation, whether or not relate d to the investigational device; 
(39) ‘serious adverse event’ means any a dverse event that led to any of the 
following: 
– death, 
– serious deterioration in the health of  the subject, that resulted in any 
of the following: 
(i) life-threatening illness or injury, (ii) permanent impairment of a body structure or a body function,  
(iii) hospitalisation or extending the duration of hospitalisation,  
(iv) medical or surgical interv ention to prevent life-threatening 
illness or injury or permanent impairment to a body structure or a body function, 
– foetal distress, foetal death or  a congenital abnormality or birth 
defect; 
(40) ‘device deficiency’ means any inadequacy  in the identity, quality, durability, 
reliability, safety or performance of an investigational device, including  
EN 34   EN malfunction, use errors or inadequacy in the information supplied by the 
manufacturer;  
Definitions related to vigila nce and market surveillance: 
(41) ‘recall’ means any measure aimed at achieving the return of a device that has 
already been made available to the end user;  
(42) ‘withdrawal’ means any measure aimed at  preventing a device in the supply 
chain from further being made available on the market; 
(43) ‘incident’ means any malfunction or dete rioration in the characteristics or 
performance of a device made available on the market, any inadequacy in the 
information supplied by the manufactur er and any unexpect ed undesirable 
side-effect; 
(44) ‘serious incident’ means any incident that  directly or indirectly led, might have 
led or might lead to any of the following: 
– death of a patient, us er or other person,  
– temporary or permanent serious deterioration of the patient's, user's 
or other person's state of health,  
– serious public health threat; 
(45) ‘corrective action’ means action taken to  eliminate the cause of a potential or 
real non-conformity or ot her undesirable situation; 
(46) ‘field safety corrective action’ means corrective action taken by the 
manufacturer for technical or medical reas ons to prevent or reduce the risk of a 
serious incident in relation to a de vice made availa ble on the market; 
(47) ‘field safety notice’ means the communication sent by the manufacturer to 
users or customers in relation to a field safety corrective action; 
(48) ‘market surveillance’ means the activities carried out and measures taken by 
public authorities to ensure that produc ts comply with the requirements set out 
in the relevant Union harmonisation le gislation and do not endanger health, 
safety or any other aspect of  public interest protection; 
Definitions related to standards a nd other technical specifications: 
(49) ‘harmonised standard’ means a European standard as defined in Article 2(1)(c) 
of Regulation (EU) No […/…]; 
(50) ‘common technical specifications’ means a document other than a standard that 
prescribes technical requirements that provide a means to comply with the legal obligation applicable to a device, process or system. 
2. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 89 to amend the list in Annex XV referred to in the last subparagraph of  
EN 35   EN number (1) of paragraph 1, in  the light of technical progr ess and taking into account 
the similarity between a medical device and a product without a medical purpose in 
respect of their characteristics and risks. 
3. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 89 in order to adapt the definition of  nanomaterial set out in number (15) of 
paragraph 1 in view of technical and sc ientific progress a nd taking into account 
definitions agreed at Union and international level. 
Article 3 
Regulatory status of products 
1. The Commission may, at the request of a Me mber State or on its own initiative, by 
means of implementing acts, determine whethe r or not a specific product, or category 
or group of products, falls within the definitio ns of 'medical device' or 'accessory to a 
medical device'. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). 
2. The Commission shall ensure the sharing of expertise between Member States in the 
fields of medical devices, in vitro  diagnostic medical devices, medicinal products, 
human tissues and cells, cosmetics, biocides , food and, if necessary, other products in 
order to determine the appropriate regulat ory status of a produc t, or category or 
group of products.  
Chapter II 
Making available of devices, oblig ations of economic operators, 
reprocessing, CE marking, free movement 
Article 4 
Placing on the market a nd putting into service 
1. A device may be placed on the market or put into service only if it complies with this 
Regulation when duly supplied and properl y installed, maintained and used in 
accordance with its intended purpose.  
2. A device shall meet the general safety and performance requirements which apply to 
it, taking into account its intended pur pose. General safety and performance 
requirements are set out in Annex I. 
3. Demonstration of conformity with the ge neral safety and performance requirements 
shall include a clinical evaluation in accordance with Article 49.  
4. Devices that are manufactured and used w ithin a single health institution shall be 
considered as being put into  service. The provisions re garding CE marking referred 
to in Article 18 and the obligations laid down in Articles 23 to 27 shall not apply to those devices, provided that manufacture and use of those devices occur under the 
health institution's single quality management system.  
EN 36   EN 5. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 89 amending or supplementing, in  the light of tec hnical progress and 
considering the intended users or patien ts, the general safety and performance 
requirements set out in Annex I, incl uding the information supplied by the 
manufacturer. 
Article 5 
Distance sales  
1. A device offered by means of information soci ety services as defined in Article 1(2) 
of Directive 98/34/EC to a natural or le gal person established in the Union shall 
comply with this Regulation at the latest  when the device is placed on the market.  
2. Without prejudice to national legislation regarding the exercise of the medical 
profession, a device that is not placed on th e market but used in the context of a 
commercial activity for the provision of a di agnostic or therapeutic service offered 
by means of information society services as  defined in Article 1(2) of Directive 
98/34/EC or by other means of communica tion to a natural or legal person 
established in the Union shall comply with this Regulation.  
Article 6 
Harmonised standards 
1. Devices which are in conformity with the relevant harmonised standards, or parts 
thereof, the references of which have been  published in the Official Journal of the 
European Union shall be presumed to be in conformity with the requirements of this Regulation covered by those sta ndards or parts thereof.  
The first subparagraph shall also apply to  system or process requirements to be 
fulfilled by economic operators or sponsors in accordance with this Regulation, including those related to the quality ma nagement system, risk management, the 
post-market surveillance pla n, clinical investig ations, clinical evaluation or post-
market clinical follow-up.  
2. Reference to harmonised standards also includes the monographs of the European 
Pharmacopoeia adopted in ac cordance with the Conventi on on the Elaboration of a 
European Pharmacopoeia, notably on surgic al sutures and on interaction between 
medicinal products and materials used in devices containing such medicinal 
products. 
Article 7 
Common technical specifications 
1. Where no harmonised standards exist or wher e relevant harmonised standards are not 
sufficient, the Commission shall be empowered to adopt common technical 
specifications (CTS) in respect of the ge neral safety and performance requirements 
set out in Annex I, the technical document ation set out in Annex II or the clinical 
evaluation and post-market clinical follow-up set out in Annex XIII. The CTS shall  
EN 37   EN be adopted by means of implementing act s in accordance with the examination 
procedure referred to in Article 88(3). 
2. Devices which are in conformity with the CTS referred to in paragraph 1 shall be 
presumed to be in conformity with the requirements of this Regulation covered by 
those CTS or parts thereof. 
3. Manufacturers shall comply with the CTS unle ss they can duly justify that they have 
adopted solutions ensuring a level of safety and performance that is at least equivalent thereto. 
Article 8 
General obligations of the manufacturer 
1. When placing their devices on the market or  putting them into se rvice, manufacturers 
shall ensure that they have been designe d and manufactured in accordance with the 
requirements of this Regulation. 
2. Manufacturers shall draw up the techni cal documentation which shall allow 
assessment of the conformity of the device with the require ments of this Regulation. 
The technical documentation shall include the elements set out in Annex II.  
The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 89 amending or supplementing, in the light of technical progress, the 
elements in the technical docum entation set out in Annex II. 
3. Where compliance of a device with th e applicable requirements has been 
demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than cust om-made or investigational devices, shall 
draw up an EU declaration of  conformity in accordance w ith Article 17 and affix the 
CE marking of conformity in accordance with Article 18. 
4. Manufacturers shall keep the technical documentation, the EU declaration of 
conformity and, if applicable, a copy of  the relevant certificate including any 
supplement, issued in accordance with Article 45, available to the competent 
authorities for a period of at least five years after the last device covered by the 
declaration of conformity ha s been placed on the market. In the case of implantable 
devices, the period shall be at least 15 y ears after the last device has been placed on 
the market. 
Where the technical documentation is volumi nous or held in diffe rent locations, the 
manufacturer shall provide, upon request  by a competent authority, a summary 
technical documentation (STED) and grant ac cess to the full technical documentation 
upon request. 
5. Manufacturers shall ensu re that procedures are in place  to keep series production in 
conformity with the requirements of this  Regulation. Changes in product design or 
characteristics and changes in the harm onised standards or CTS by reference to 
which conformity of a product is declared  shall be adequately taken into account. 
Proportionate to the risk cla ss and the type of device, ma nufacturers of devices, other  
EN 38   EN than custom-made or investigational devices , shall institute and keep up to date a 
quality management system that shall a ddress at least the following aspects:  
(a) the responsibility of  the management;  
(b) resource management, including selecti on and control of suppliers and sub-
contractors; 
(c) product realisation;  
(d) processes for monitoring and measuremen t of output, data analysis and product 
improvement.  
6. Proportionate to the risk cla ss and the type of device, ma nufacturers of devices, other 
than custom-made devices, shall institute a nd keep up to date a systematic procedure 
to collect and review experience gained fr om their devices placed on the market or 
put into service and to apply any necessary  corrective action, hereinafter referred to 
as ‘post-market surveillance plan’. The post- market surveillance plan shall set out the 
process for collecting, recording and inve stigating complaints and reports from 
healthcare professionals, patien ts or users on suspected in cidents related to a device, 
keeping a register of non-conforming produc ts and product recall s or withdrawals, 
and if deemed appropriate due to the nature of the device, sample testing of marketed 
devices. Part of the post-market surveillan ce plan shall be a plan for post-market 
clinical follow-up in accordance with Pa rt B of Annex XIII. Where post-market 
clinical follow-up is not deemed neces sary, this shall be duly justified and 
documented in the post-market surveillance plan. 
If in the course of the post-market su rveillance a need for corrective action is 
identified, the manufacturer shall implement the appropriate measures. 
7. Manufacturers shall ensure that the device is accompanied by the information to be 
supplied in accordance with Section 19 of Annex I in an official Union language 
which can be easily understood  by the intended user or pa tient. The language(s) of 
the information to be supplied by the manufacturer may be determined by the law of the Member State where the device is ma de available to the user or patient. 
8. Manufacturers who consider or have reason to  believe that a device which they have 
placed on the market is not in conformity w ith this Regulation shall immediately take 
the necessary corrective action to bring that  product into conformity, withdraw it or 
recall it, as appropriate. They shall inform the distributors and, where applicable, the 
authorised representative accordingly.  
9. Manufacturers shall, in response to a reas oned request from a competent authority, 
provide it with all the in formation and documentation ne cessary to demonstrate the 
conformity of the device, in an offi cial Union language which can be easily 
understood by that authority. They shall coopera te with that authority, at its request, 
on any corrective action taken to eliminate the risks posed by devices which they have placed on the market or put into service.  
10. Where manufacturers have their devices desi gned and manufactured by another legal 
or natural person the information on the ident ity of that person shall be part of the 
information to be submitted in accordance with Article 25.   
EN 39   EN Article 9 
Authorised representative 
1. A manufacturer of a device that is placed on the Union market, or bears the CE 
marking without being placed on the Union market, who does not have a registered 
place of business in a Member State or doe s not carry out relevant activities at a 
registered place of business in a Member St ate, shall designate a single authorised 
representative.  
2. The designation shall be valid only when accepted in writing by the authorised 
representative and shall be e ffective at least for all devices of the same generic device 
group.  
3. The authorised representative shall perform the tasks specified in the mandate agreed 
between the manufacturer and th e authorised representative.  
The mandate shall allow and require the authorised representative to perform at least 
the following tasks in relation to the devices that it covers: 
(a) keep the technical documen tation, the EU declaration of conformity and, if 
applicable, a copy of the relevant certifi cate including any supplement issued in 
accordance with Article 45 at the dispos al of competent authorities for the 
period referred to in Article 8(4); 
(b) in response to a reasoned request fr om a competent authority, provide that 
competent authority with all the info rmation and documentation necessary to 
demonstrate the conformity of a device;  
(c) cooperate with the compet ent authorities on any co rrective action taken to 
eliminate the risk s posed by devices; 
(d) immediately inform the manufacturer about complaints and reports from 
healthcare professionals, patients and user s about suspected incidents related to 
a device for which they have been designated;  
(e) terminate the mandate if th e manufacturer acts contrary  to his obligations under 
this Regulation.  
To allow the authorised representative to fulfil the tasks mentioned in this paragraph, 
the manufacturer shall at least ensure th at the authorised representative has 
permanent immediate access to the necessary  documentation in one of the official 
Union languages. 
4. The mandate referred to in paragraph 3 shall not include the delegation of the 
manufacturer's obligations laid down in Ar ticle 8(1), (2), (5), (6), (7) and (8). 
5. An authorised representative who terminat es the mandate on the grounds referred to 
in point (e) of paragraph 3 shall immediately inform the competent authority of the 
Member State in which he is established and, where applicable, the notified body that 
was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefor.  
EN 40   EN 6. Any reference in this Regulation to the competent authority of the Member State 
where the manufacturer has his registered pl ace of business shall be understood as a 
reference to the competent authority of the Member State where the authorised 
representative, designated by a manufacturer  referred to in paragraph 1, has his 
registered place of business.  
Article 10 
Change of authorised representative 
The modalities of a change of authorised representative shall be clearly defined in an 
agreement between the manufacturer, the outgoing authorised representative and the incoming 
authorised representative. This agreement sh all address at least th e following aspects:  
(a) the date of termination of the mandate with the outgoing authorised 
representative and date of beginni ng of the mandate with the incoming 
authorised representative; 
(b) the date until which the outgoing authoris ed representative ma y be indicated in 
the information supplied by the manuf acturer, including any promotional 
material;  
(c) the transfer of documents, including conf identiality aspects and property rights; 
(d) the obligation of the outgoing authorised representative after the end of the 
mandate to forward to the manufacturer or  incoming authorised representative 
any complaints or reports from healthcar e professionals, patients or users about 
suspected incidents related to a device for which he had been designated as 
authorised representative. 
Article 11 
General obligations of importers  
1. Importers shall place on the Union market onl y devices that are in conformity with 
this Regulation. 
2. Before placing a device on the market im porters shall ensure the following:  
(a) that the appropriate conformity assessm ent procedure has been carried out by 
the manufacturer;  
(b) that an authorised representative in accordance with Article 9 has been 
designated by the manufacturer; 
(c) that the EU declaration of conform ity and the technical documentation has 
been drawn up by the manufacturer;  
(d) that the device bears the require d CE marking of conformity;  
(e) that the device is labelled in accordan ce with this Regulation and accompanied 
by the required instructio ns for use and EU declaration of conformity;  
EN 41   EN (f) that, where applicable, a Unique Device Identification has been assigned by the 
manufacturer in accordance with Article 24. 
Where an importer considers or has reason to believe that a device is not in 
conformity with the requirements of this Regulation, he shall not place the device on 
the market until it has been brought into c onformity. Where the device presents a 
risk, the importer shall inform the manufactur er and his authorised representative to 
that effect, as well as the competent author ity of the Member State in which he is 
established. 
3. Importers shall indicate their name, register ed trade name or registered trade mark 
and the address of their registered place of  business at which they can be contacted 
and their location can be established on th e device or on its packaging or in a 
document accompanying the device. They sha ll ensure that any additional label does 
not obscure any information on the label provided by the manufacturer. 
4. Importers shall ensure that the device is registered in the electronic system in 
accordance with Article 25(2).  
5. Importers shall ensure that, while a device  is under their respons ibility, storage or 
transport conditions do not je opardise its compliance with  the general safety and 
performance requirements set out in Annex I. 
6. When deemed appropriate with regard to the risks presented by a device, importers 
shall, in order to protect the health and sa fety of patients and users, carry out sample 
testing of marketed products , investigate complaints and keep a register of 
complaints, of non-conforming products and of product recalls a nd withdrawals, and 
shall keep the manufacturer, authorised re presentative and dist ributors informed of 
such monitoring.  
7. Importers who consider or have reason to  believe that a device which they have 
placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and his authorised  representative and, if appropriate, take 
the necessary corrective action to bring that device into conformity, withdraw or recall it. Where the device presents a risk, they shall also immediately inform the 
competent authorities of the Member States  in which they made the device available 
and, if applicable, the notified body that issued a certificate in accordance with 
Article 45 for the device in question, giving  details, in particular, of the non-
compliance and of any corrective action taken. 
8. Importers who have received complaints or reports from healthcare professionals, 
patients or users about suspected incidents re lated to a device whic h they have placed 
on the market shall immediately forward this  information to the manufacturer and his 
authorised representative. 
9. Importers shall, for the period referred to in Article 8(4), keep a copy of the EU 
declaration of conformity at the disposal of the market surveill ance authorities and 
ensure that the technical documentation a nd, if applicable, a copy of the relevant 
certificate including any supplement, issued  in accordance with Article 45, can be 
made available to those authorities, upon request. By written mandate, the importer  
EN 42   EN and the authorised representative for the device in question may agree that this 
obligation is delegated to the authorised representative. 
10. Importers shall, in response to a request from a competent national authority, provide 
it with all the information and documen tation necessary to demonstrate the 
conformity of a product. This obligation shall be considered fulfilled when the 
authorised representative for the de vice in question provides the required 
information. Importers shall cooperate with  a competent nationa l authority, at its 
request, on any action taken to eliminate th e risks posed by products which they have 
placed on the market. 
Article 12 
General obligations of distributors 
1. When making a device available on the market , distributors shall act  with due care in 
relation to the requi rements applicable. 
2. Before making a device available on the ma rket distributors shall verify that the 
following requirements are met: 
(a) the product bears the required CE marking of conformity;  
(b) the product is accompanied by the information to be supplied by the 
manufacturer in accordance with Article 8(7); 
(c) the manufacturer and, where applicable, the importer have complied with the 
requirements set out in Article 24 and Article 11(3) respectively. 
Where a distributor considers or has reas on to believe that a device is not in 
conformity with the requirements of this Regulation, he shall not make the device available on the market until it has been brought into conformity. Where the device 
presents a risk, the distributor shall info rm the manufacturer and, where applicable, 
his authorised representative and the importer to that effect, as well as the competent 
authority of the Member State in which he is established. 
3. Distributors shall ensu re that, while a device is under their responsibility, storage or 
transport conditions do not je opardise its compliance with  the general safety and 
performance requirements set out in Annex I. 
4. Distributors who consider or have reason to believe that a device which they have 
made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised 
representative and the importer and make sure  that the necessary corrective action to 
bring that device into conformity, withdraw  or recall it, if appropriate, is taken. 
Where the device presents a risk, they sha ll also immediately inform the competent 
authorities of the Member States in whic h they made the device available, giving 
details, in particular, of the non-complia nce and of any corre ctive action taken.  
5. Distributors who have receive d complaints or reports fr om healthcare professionals, 
patients or users about susp ected incidents related to a device they have made  
EN 43   EN available, shall immediately forward this information to the manufacturer and, where 
applicable, his authorised representative.  
6. Distributors shall, in response to a reque st from a competent authority, provide it 
with all the information and documentation necessary to demonstr ate the conformity 
of a device. This obligation shall be considered fulfilled when the authorised representative for the devi ce in question, where applicab le, provides the required 
information. Distributors shall cooperate with  competent national au thorities, at their 
request, on any action taken to eliminate th e risks posed by devices which they have 
made available on the market. 
Article 13 
Person responsible for regulatory compliance 
1. Manufacturers shall have available within their organisation at least one qualified 
person who possesses expert knowledge in th e field of medical devices. The expert 
knowledge shall be demonstrated by e ither of the following qualifications: 
(a) a diploma, certificate or other eviden ce of formal qualification awarded on 
completion of a university degree or of an  equivalent course of study, in natural 
sciences, medicine, pharmacy, engineering or another relevant discipline, and 
at least two years of prof essional experience in regulat ory affairs or in quality 
management systems relating to medical devices;  
(b) five years of professional experience in regulatory affairs or in quality 
management systems relating to medical devices.  
Without prejudice to national provisions regarding professional qualifications, 
manufacturers of custom-made devices may demonstrate their expert knowledge 
referred to in the first subparagraph by at least two years of pr ofessional experience 
within the relevant fi eld of manufacture.  
This paragraph shall not apply to manuf acturers of custom-made devices who are 
micro-enterprises as defined by Commission Recommendation 2003/361/EC
54. 
2. The qualified person shall at least be respons ible for ensuring the following matters:  
(a) that the conformity of the devices is a ppropriately assessed before a batch is 
released; 
(b) that the technical documentation and the declaration of conformity are drawn 
up and kept up-to-date;  
(c) that the reporting obligations in accord ance with Articles 61 to 66 are fulfilled; 
(d) in the case of investigationa l devices, that the statement referred to in point 4.1 
of Chapter II of Annex XIV is issued.  
                                                 
54 OJ L 124, 20.5.2003, p. 36  
EN 44   EN 3. The qualified person shall suffer no disa dvantage within the manufacturer's 
organisation in relation to the proper fulfilment of his duties. 
4. Authorised representatives shall have availa ble within their organisation at least one 
qualified person who possesses expert knowledge regarding the regulatory 
requirements for medical devices in the Union. The expert knowledge shall be demonstrated by either of the following qualifications: 
(a) a diploma, certificate or other eviden ce of formal qualification awarded on 
completion of a university degree or of an  equivalent course of study, in law, 
natural sciences, medicine, pharmacy, engineering or another relevant 
discipline, and at least two years of professional experience in regulatory 
affairs or in quality management sy stems relating to medical devices;  
(b) five years of professional experience in regulatory affairs or in quality 
management systems relating to medical devices. 
Article 14 
Cases in which obligations of manufacturers apply to importers, distributors or other persons 
1. A distributor, importer or othe r natural or legal person shall assume the obligations 
incumbent on manufacturers if he does any of the following: 
(a) makes available on the market a device under his name, registered trade name 
or registered trade mark;  
(b) changes the intended purpose of a devi ce already placed on the market or put 
into service;  
(c) modifies a device already placed on the ma rket or put into service in such a 
way that compliance with the applicab le requirements may be affected.  
The first subparagraph shall not apply to any person who,  while not considered a 
manufacturer as defined in num ber (19) of Article 2(1), assembles or adapts a device 
already on the market to its intende d purpose for an individual patient. 
2. For the purposes of point (c ) of paragraph 1, the following shall not be considered to 
be a modification of a device that could a ffect its compliance with the applicable 
requirements: 
(a) provision, including translation, of  the information supplied by the 
manufacturer in accordance with Secti on 19 of Annex I relating to a device 
already placed on the market and of further information which is necessary in order to market the product in  the relevant Member State; 
(b) changes to the outer packaging of a device already placed on the market, 
including a change of pack  size, if the repackaging is necessary in order to 
market the product in the relevant Member State and if it is carried out in such 
conditions that the original condition of  the device cannot be affected by it. In 
the case of devices placed on the mark et in sterile co ndition, it shall be 
presumed that the original condition of the device is adversely affected if the  
EN 45   EN package that shall ensure the sterile c ondition is opened, damaged or otherwise 
negatively affected by the repackaging. 
3. A distributor or importer who carries out any of the activities menti oned in points (a) 
and (b) of paragraph 2 shall indicate the act ivity carried out together with his name, 
registered trade name or registered trade mark and the address at which he can be 
contacted and his location can  be established on the devi ce or, where that is not 
possible, on its packaging or in a document accompanying the device.  
He shall ensure that he has in place a quality management system that includes 
procedures which ensure that the transla tion of information is accurate and up-to-
date, and that the activities mentioned in  points (a) and (b) of paragraph 2 are 
performed by means and under conditions that  preserve the original condition of the 
device and that the packaging of the repack aged device is not defective, of poor 
quality or untidy. Part of the quality management system shall be procedures 
ensuring that the distributor or importer is  informed of any corrective action taken by 
the manufacturer in relation to the device in  question in order to  respond to safety 
issues or to bring it in c onformity with this Regulation. 
4. Prior to making the relabelled or repackag ed device available, the distributor or 
importer referred to in paragraph 3 shall in form the manufacturer and the competent 
authority of the Member State where he plans to make the device available and, upon 
request, shall provide them with a sample  or a mock-up of the relabelled or 
repackaged device, including any translated label and instructions for use. He shall 
submit to the competent authority a certificat e, issued by a notified body referred to 
in Article 29, designated for the type of devices that are subject to activities 
mentioned in points (a) and (b) of paragra ph 2, attesting that the quality management 
system complies with the require ments laid down in paragraph 3. 
Article 15 
Single-use devices and their reprocessing 
1. Any natural or legal person who reprocesses a single-use device to make it suitable 
for further use within the Union shall be c onsidered to be the manufacturer of the 
reprocessed device and shall assume the obl igations incumbent on manufacturers laid 
down in this Regulation. 
2. Only single-use devices that have been placed on the Union market in accordance 
with this Regulation, or prior to [date of application of th is Regulation] in accordance 
with Directive 90/385/EEC or Directiv e 93/42/EEC may be reprocessed.  
3. In the case of reprocessing of single-use devices for critic al use, only reprocessing 
that is considered safe according to the late st scientific evidence  may be carried out.  
4. The Commission, by means of implementing acts, shall establish and regularly 
update a list of categories or groups of singl e-use devices for critical use which may 
be reprocessed in accordance with paragraph 3. Those implementing acts shall be adopted in accordance with the examination procedure refe rred to in Article 88(3).  
5. The name and address of the legal or natu ral person referred to in paragraph 1 and 
the other relevant information in accordan ce with Section 19 of  Annex I shall be  
EN 46   EN indicated on the label and, where applicab le, in the instructions for use of the 
reprocessed device.  
The name and address of the manufacturer of the original single-use device shall no 
longer appear on the label, but  shall be mentioned in the instructions for use of the 
reprocessed device.  
6. A Member State may maintain or introduce national provisions prohibiting, within 
its territory, on grounds of prot ection of public hea lth specific to th at Member State 
the following: 
(a) the reprocessing of single-use devices and the transfer of single-use devices to 
another Member State or to a third country with a view  to their reprocessing;  
(b) the making available of repr ocessed single-use devices. 
Member States shall notify the Commission and the other Member States of the 
national provisions and the grounds for introducing them. The Commission shall 
keep the information publicly available.  
Article 16 
Implant card 
1. The manufacturer of an implan table device shall provide t ogether with the device an 
implant card which shall be made available to the particular patient who has been 
implanted with the device.  
2. This card shall contain the following: 
(a) the information allowing identificati on of the device, including the Unique 
Device Identification; 
(b) any warnings, precautions or measures to be taken by the patient or a 
healthcare professional with regard to reciprocal inte rference with reasonably 
foreseeable external influences or environmental conditions; 
(c) any information about the expected life time of the device and any necessary 
follow-up. 
The information shall be written in a way that is readily understood by a lay person.  
Article 17 
EU declaration of conformity 
1. The EU declaration of conformity shall state that fulfilment of the requirements 
specified in this Regulation has been dem onstrated. It shall be continuously updated. 
The minimum content of the EU declaration of  conformity is set out in Annex III. It 
shall be translated into the official Un ion language or langua ges required by the 
Member State(s) in which the device is made available.   
EN 47   EN 2. Where, concerning aspects not covered by this Regulation, devi ces are subject to 
other Union legislation which also requi res a declaration of conformity by the 
manufacturer that fulfilment of the requ irements of that legislation has been 
demonstrated, a single EU declaration of c onformity shall be drawn up in respect of 
all Union acts applicable to the device containing all information required for identification of the Union legislation to which the declaration relates.  
3. By drawing up the EU declaration of co nformity, the manufacturer shall assume 
responsibility for compliance wi th the requirements of th is Regulation and all other 
Union legislation applicable to the device. 
4. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 89 amending or supplementing the min imum content of the EU declaration of 
conformity set out in Annex III in the light of technical progress.  
Article 18 
CE marking of conformity 
1. Devices, other than custom-made or investig ational devices, cons idered to be in 
conformity with the requirements of this  Regulation shall bear the CE marking of 
conformity, as presented in Annex IV. 
2. The CE marking shall be subject to the ge neral principles set out in Article 30 of 
Regulation (EC) No 765/2008. 
3. The CE marking shall be affi xed visibly, legibl y and indelibly to the device or its 
sterile pack. Where that is not possible or not warranted on account of th e nature of 
the device, it shall be affixed to the pack aging. The CE marking shall also appear in 
the instructions for use and on the sale s packaging where those are provided.  
4. The CE marking shall be affixed before the device is placed on the market. It may be 
followed by a pictogram or any other mark  indicating a special risk or use.  
5. Where applicable, the CE marking shall be followed by the identification number of 
the notified body responsible for the confor mity assessment procedures set out in 
Article 42. The identification number shall also be indicated in any promotional 
material which mentions that a device fulf ils the legal requirements for CE marking.  
6. Where devices are subject to other Union legislation concerning other aspects which 
also provide for the affixing of the CE ma rking, the CE marking shall indicate that 
the devices also fulfil the provi sions of the other legislation. 
Article 19 
Devices for special purposes 
1. Member States shall not create a ny obstacle to the following devices: 
(a) investigational devices wh ich are supplied to a docto r of medicine, a dental 
practitioner or an authorised person for th e purpose of clinical investigation if 
they meet the conditions laid down in Articles 50 to 60 and in Annex XIV;   
EN 48   EN (b) custom-made devices which are made available on the market if they comply 
with Article 42(7) and Annex XI. 
Those devices shall not bear the CE ma rking, with the exception of the devices 
referred to in Article 54.  
2. Custom-made devices shall be accompanied by the statement referred to in Annex XI 
which shall be made available to the particul ar patient or user identified by name, an 
acronym or a numerical code. 
Member States may require that the manuf acturer of a custom-made device submit to 
the competent authority a list of such devi ces which have been made available in 
their territory. 
3. At trade fairs, exhibitions, demonstrations or similar events, Member States shall not 
create any obstacle to the showing of devices which do  not comply with this 
Regulation, provided a visible sign clearly indicates that such devices are intended 
for presentation or demonstration purposes only and cannot be ma de available until 
they have been made to comply with this Regulation.  
Article 20 
Systems and procedure packs 
1. Any natural or legal person sh all draw up a statement referred to in paragraph 2 if he 
puts devices bearing the CE marking togeth er with the followi ng other devices or 
products, in accordance with the intended pu rpose of the devices or other products 
and within the limits of use specified by th eir manufacturers, in order to place them 
on the market as a system or procedure pack:  
– other devices bearing the CE marking; 
– in vitro  diagnostic medical devices  bearing the CE marking in conformity with 
Regulation (EU) […/…]; 
– other products which are in conformity with the legislation applicable to those 
products.  
2. In the statement, the person referred to in paragraph 1 shall declare the following: 
(a) that he verified the mutual compatibility  of the devices and, if applicable other 
products, in accordance with the manufacturer s' instructions and has carried out 
his operations in accordance with those instructions; 
(b) that he packaged the system or procedure pack and supplied relevant 
information to users incorporating th e information to be supplied by the 
manufacturers of the devices or other products which have been put together; 
(c) that the activity of putting devices and, if applicable, other products together as 
a system or procedure pack was subject  to appropriate methods of internal 
monitoring, verifica tion and validation.  
EN 49   EN 3. Any natural or legal person who sterilises systems or procedure packs referred to in 
paragraph 1 for the purpose of placing them on the market shall, at his choice, follow 
one of the procedures referred to in A nnex VIII or in Part A of Annex X. The 
application of those Annexes and the i nvolvement of the notified body shall be 
limited to the aspects of the procedure rela ting to ensuring steril ity until the sterile 
package is opened or damaged. The person shall draw up a statem ent declaring that 
sterilisation has been carried out in accordance with the manufacturer's instructions. 
4. Where the system or procedure pack incorporate devices which do not bear the CE 
marking or where the chosen combination of  devices is not compatible in view of 
their original intended purpose, the system or procedure pack sh all be treated as a 
device in its own right and shall be subjec ted to the relevant conformity assessment 
procedure pursuant to Article 42. 
5. The systems or procedure pack s referred to in paragraph 1 shall not themselves bear 
an additional CE marking but they shall b ear the name, registered trade name or 
registered trade mark of the person referred to in paragraph 1 as well as the address 
at which he can be contacted and his lo cation can be established. Systems or 
procedure packs shall be accompanied by the information referred to in Section 19 of 
Annex I. The statement referred to in paragra ph 2 of this Article sh all be kept at the 
disposal of the competent authorities, afte r the system or procedure pack has been 
put together, for the period that is appl icable to the devices  put together in 
accordance with Article 8(4). Where these periods differ, the longest period shall 
apply.  
Article 21 
Parts and components 
1. Any natural or legal person who makes avai lable on the market an article intended 
specifically to replace an identical or simila r integral part or component of a device 
that is defective or worn in order to maintain or re-establish the function of the device without significantly ch anging its performance or sa fety characteristics, shall 
ensure that the article does not adversely affect the safety and performance of the 
device. Substantiating evidence shall be ke pt available to the competent authorities 
of the Member States.  
2. An article that is intended specifically to  replace a part or component of a device and 
that significantly changes the performance or safety characteristics of the device shall 
be considered a device. 
Article 22 
Free movement 
Member States shall not refuse, prohibit or rest rict the making available or putting into service 
within their territory of devices which comp ly with the requirement s of this Regulation.  
EN 50   EN Chapter III 
Identification and traceability of devices, registrati on of devices 
and of economic operators, summ ary of safety and clinical 
performance, European data bank on medical devices  
Article 23 
Identification within  the supply chain 
For devices, other than custom-made or invest igational devices, economic  operators shall be 
able to identify the following, for th e period referred to in Article 8(4): 
(a) any economic operator to whom they have supplied a device; 
(b) any economic operator who has s upplied them with a device; 
(c) any health institution or healthcare professional to whom they have supplied a 
device. 
Upon request, they shall inform the competent authorities thereof.  
Article 24 
Unique Device Identification system 
1. For devices, other than custom-made a nd investigational devices, a system for 
Unique Device Identification shall be put  in place in the Union. The UDI system 
shall allow the identification and traceability of devices and shall consist of the following: 
(a) production of a UDI that comprises the following: 
(i) a device identifier specific to a manufacturer and a device model, 
providing access to the information la id down in Part B of Annex V;  
(ii) a production identifier that identifies data relate d to the unit of device 
production; 
(b) placement of the UDI on the label of the device; 
(c) storage of the UDI by the economic operators and the health institutions 
through electronic means; 
(d) establishment of an el ectronic system on UDI. 
2. The Commission shall designate one or seve ral entities that ope rate a system for 
assignment of UDIs pursuant to this Regulat ion and that satisfy all of the following 
criteria: 
(a) the entity is an organisati on with legal personality;  
EN 51   EN (b) its system for the assignment of UDIs is  adequate to identi fy a device through 
its distribution and use in accordance with  the requirements of this Regulation; 
(c) its system for the assignment of UDIs conforms to the relevant international 
standards; 
(d) the entity gives access to its system for the assignment of UDIs to all interested 
users according to a set of predetermi ned and transparent terms and conditions; 
(e) the entity undertakes the following: 
(i) to operate its system for the assignment of UDIs for the period to be 
determined in the designation which shall at least be three years after its designation;  
(ii) to make available to the Comm ission and to the Member States, upon 
request, information concerning its system for the assignment of UDIs 
and concerning manufacturers that place an UDI on the label of their 
device in accordance with  the entity's system; 
(iii) to remain in compliance with the criteria for designation and the terms of 
designation during the period fo r which it is designated.  
3. Before placing a device on the market, the ma nufacturer shall assign to the device a 
UDI provided by an entity designated by the Commission in accordance with 
paragraph 2, if that device belongs to th e devices, categories or groups of devices 
determined by a measure referred to  in point (a) of paragraph 7.  
4. The UDI shall be placed on the label of th e device, in accordance with the conditions 
laid down by a measure referred to in point (c) of paragraph 7. It  shall be used for 
reporting serious incidents and field safety  corrective actions in accordance with 
Article 61 and shall be included in the im plant card referred to in Article 16. The 
device identifier shall appear on the EU d eclaration of conformity referred to in 
Article 17 and in the tec hnical documentation refe rred to in Annex II.  
5. Economic operators and health institutions shall store and keep, by electronic means, 
the device identifier and the production id entifier of the devices which they have 
supplied or they have been supplied with, if  they belong to the devices, categories or 
groups of devices determined by a measure re ferred to in point (a) of paragraph 7. 
6. The Commission, in cooperation with the Me mber States, shall set up and manage an 
electronic system on UDI to co llate and process the information mentioned in Part B 
of Annex V. This information shall be accessible to the public. 
7. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 89:  
(a) determining the devices, categories or groups of devices wh ose identification 
shall be based on the UDI system as se t out in paragraphs  1 to 6, and the 
timelines for implementing this. Following a risk-based approach, implementation of the UDI system sha ll be gradual, starting with devices 
falling in the highe st risk class;  
EN 52   EN (b) specifying the data to be included in the production identifier which, following 
a risk based approach, may vary depending on the risk class of the device; 
(c) defining the obligations of economic operators, of health institutions and of 
professional users, in pa rticular regarding alloca tion of the numeric or 
alphanumeric characters, placement of  the UDI on the label, storage of 
information in the electronic system on UDI and use of the UDI in documentation and reporting related to the device provided for in this 
Regulation; 
(d) amending or supplementing the list of info rmation set out in Part B of Annex V 
in the light of technical progress. 
8. When adopting the measures referred to in  paragraph 7, the Commission shall take 
into account the following: 
(a) the protection of personal data; 
(b) the legitimate interest in protecting commercially sensitive information; 
(c) the risk-based approach; 
(d) the cost-effectiveness of the measures; 
(e) the convergence of UDI systems deve loped at international level.  
Article 25 
Electronic system on registration of devices and economic operators 
1. The Commission, in collaboration with the Member States, shall set up and manage 
an electronic system to collate and pr ocess information that is necessary and 
proportionate to describe and identify the device and to identify the manufacturer 
and, where applicable, the authorised repr esentative and the importer. The details 
regarding the information to be submitted by the economic operators are laid down in Part A of Annex V. 
2. Before a device, other than a custom-made or  investigational device, is placed on the 
market the manufacturer or his authoris ed representative shall submit to the 
electronic system the informati on referred to in paragraph 1.  
3. Within one week after placing a device, ot her than a custom-made or investigational 
device, on the market, importers shall submit to the electronic system the information referred to in paragraph 1.  
4. Within one week of any change occurring in relation to the information referred to in 
paragraph 1, the relevant economic operato r shall update the data in the electronic 
system. 
5. Not later than two years after submission of the information in accordance with 
paragraphs 2 and 3, and then every second year, the relevant economic operator shall 
confirm the accuracy of the data . In the event of failure to confirm within six months  
EN 53   EN of the due date, any Member State may ta ke measures to suspend or otherwise 
restrict the making available of the device in question within its territory until the 
obligation referred to in this paragraph is complied with.  
6. The data contained in the electronic sy stem shall be accessible to the public.  
7. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 89 amending the list of information to be submitted as set out in Part A of Annex V in the light of technical progress.  
Article 26 
Summary of safety and clinical performance 
1. In the case of devices classified as cla ss III and implantable devices, other than 
custom-made or investigational devices, the manufacturer shall draw up a summary 
of safety and clinical performance. It shall be written in a way that is clear to the intended user. The draft of this summary sh all be part of the documentation to be 
submitted to the notified body involved in the conformity assessment in accordance 
with Article 42 and shall be  validated by that body.  
2. The Commission may, by means of implementing acts, set out the form and the 
presentation of the data elements to be included in the summary of safety and clinical 
performance. Those implementing acts shal l be adopted in accordance with the 
advisory procedure referred  to in Article 88(2).  
Article 27 
European databank 
1. The Commission shall develop and manage  the European databank on medical 
devices (Eudamed) for the following purposes:  
(a) to enable the public to be adequately  informed about devices placed on the 
market, about the corres ponding certificates issued by notified bodies and 
about the relevant economic operators; 
(b) to enable traceability of devices  within the internal market; 
(c) to enable the public to be adequately in formed about clinical investigations and 
to enable sponsors of clinical investiga tions to be conducted in more than one 
Member State to comply with informa tion obligations under Articles 50 to 60; 
(d) to enable manufacturers to comply with  information obligations under Articles 
61 to 66; 
(e) to enable the competent authorities of the Member States and the Commission 
to carry out their tasks relating to this Regulation on a well informed basis and to enhance the cooperation between them.  
2. Eudamed shall include the follo wing as integral parts:  
EN 54   EN (a) the electronic system on UDI referred to in Article 24;  
(b) the electronic system on registrati on of devices and economic operators 
referred to in Article 25; 
(c) the electronic system on information on certi ficates referred to in Article 45(4);  
(d) the electronic system on clinical inve stigations referred to in Article 53, 
(e) the electronic system on vigilan ce referred to in Article 62; 
(f) the electronic system on market surv eillance referred to in Article 68. 
3. The data shall be entered into Eudame d by the Member States, notified bodies, 
economic operators and sponsors as specif ied in the provisions concerning the 
electronic systems referr ed to in paragraph 2. 
4. All the information collated and processed by Eudamed shall be accessible to the 
Member States and to the Commission. Th e information shall be accessible to 
notified bodies, economic operators, sponsors and the public to the extent defined in 
the provisions referred to in paragraph 2.  
5. Eudamed shall contain personal data only insofar as this is necessary for the 
electronic systems referred to in paragraph 2 to collate and process the information in 
accordance with this Regulation. Personal data shall be kept in a form which permits 
identification of the data subjects for no long er than the periods referred to in Article 
8(4).  
6. The Commission and the Member States sh all ensure that the data subjects may 
effectively exercise their rights to informa tion, to access, to rectify and to object in 
accordance with Regulation (EC) No 45/2001 and Directive 95/46/EC, respectively. 
They shall ensure that the data subjects ma y effectively exercise the right of access to 
data relating to them, and the right to have  inaccurate or incomp lete data corrected 
and erased. Within their respective respons ibilities, the Commission and the Member 
States shall ensure that inaccurate and unlawfully processed data is deleted, in accordance with the applicable legislation. Co rrections and deletions shall be carried 
out as soon as possible, but no later than within 60 days after a request is made by a 
data subject. 
7. The Commission shall, by means of im plementing acts, lay down the modalities 
necessary for the development and mana gement of Eudamed. Those implementing 
acts shall be adopted in accordance with the examination procedure referred to in 
Article 88(3). 
8. In relation to its responsibilit ies under this Article and the processing of personal data 
involved therein, the Commission shall be c onsidered controller of Eudamed and its 
electronic systems.  
EN 55   EN Chapter IV 
Notified bodies 
Article 28 
National authorities respons ible for notified bodies 
1. A Member State that intends to designate a conformity assessment body as a notified 
body, or has designated a notified body, to carry out third-party conformity assessment tasks under this Regulation shall designate an authority that shall be 
responsible for setting up and carrying out the necessary procedures for the assessment, designation and no tification of conformity a ssessment bodies and for the 
monitoring of notified bodies, including subc ontractors or subsidiaries of those 
bodies, hereinafter referred to as the ‘n ational authority res ponsible for notified 
bodies’. 
2. The national authority responsible for notifie d bodies shall be es tablished, organised 
and operated so as to safeguard  the objectivity and impartiality  of its activities and to 
avoid any conflicts of interests w ith conformity assessment bodies.  
3. It shall be organised so that each decisi on relating to notification of a conformity 
assessment body is taken by personnel different from those who carried out the assessment of the conformity assessment body. 
4. It shall not perform any activities that conformity assessmen t bodies perform nor 
provide consultancy services on a commercial or competitive basis.  
5. The national authority responsible fo r notified bodies shall safeguard the 
confidentiality of the information it obtains. However, it shall exchange information on a notified body with other Member States and the Commission.  
6. The national authority responsible for notif ied bodies shall have a sufficient number 
of competent personnel at its disposal for the proper performance of its tasks.  
Without prejudice to Article 33(3), where a national authority is responsible for the 
designation of notified bodies in  the field of products othe r than medical devices, the 
competent authority for medical devices shall be consulted on all aspects specifically related to medical devices.  
7. Member States shall provide the Commi ssion and the other Member States with 
information on their procedures for the as sessment, designation and notification of 
conformity assessment bodies and for the monitoring of notified bodies, and of any changes thereto. 
8. The national authority responsible for notif ied bodies shall be peer-reviewed every 
second year. The peer-review shall includ e an on-site visit to a conformity 
assessment body or a notified body under th e responsibility of the reviewed 
authority. In the case referred to in the second subparagraph of paragraph 6, the 
competent authority for medical devices shall participate in the peer-review.   
EN 56   EN The Member States shall draw up the annual plan for the peer-review, ensuring an 
appropriate rotation in respect  of reviewing and reviewed authorities, and submit it to 
the Commission. The Commission may particip ate in the review. The outcome of the 
peer-review shall be communicated to all Member States and to the Commission and 
a summary of the outcome shall be made publicly available. 
Article 29 
Requirements relating to notified bodies 
1. Notified bodies shall satisfy the organisa tional and general requirements and the 
quality management, resource and process re quirements that are necessary to fulfil 
their tasks for which they are designate d in accordance with this Regulation. 
Minimum requirements to be met by notif ied bodies are set out in Annex VI.  
2. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 89 amending or supplementing the minimum requirements in Annex VI, in 
the light of technical progress and consid ering the minimum requirements needed for 
the assessment of specific devices, or  categories or groups of devices. 
Article 30 
Subsidiaries and subcontracting 
1. Where a notified body subcontracts specif ic tasks connected with conformity 
assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcontractor or the subsidiary meets 
the relevant requirements set out in Annex VI and shall inform the national authority 
responsible for notified bodies accordingly. 
2. Notified bodies shall take full responsibility for the tasks performed on their behalf 
by subcontractors or subsidiaries. 
3. Conformity assessment activities may be subc ontracted or carried out by a subsidiary 
only with the agreement of th e legal or natural person th at applied for conformity 
assessment. 
4. Notified bodies shall keep at  the disposal of the nationa l authority responsible for 
notified bodies the relevant documents  concerning the verification of the 
qualifications of the subcontractor or the s ubsidiary and the work carried out by them 
under this Regulation. 
Article 31 
Application by a conformity assessment body for notification 
1. A conformity assessment body shall submit an  application for notification to the 
national authority responsible for notified bodi es of the Member State in which it is 
established. 
2. The application shall specify the conform ity assessment activities, the conformity 
assessment procedures and the devices for which the body claims to be competent,  
EN 57   EN supported by documentation proving complianc e with all the requirements set out in 
Annex VI.  
In respect of the organisational and general requirements and the quality 
management requirements set out in Sect ions 1 and 2 of Anne x VI, the relevant 
documentation may be submitted in form of  a valid certificate and the corresponding 
evaluation report delivered by a national accreditation body in accordance with 
Regulation (EC) No 765/2008. The conformity assessment body shall be presumed 
to be in conformity with the requiremen ts covered by the certificate delivered by 
such accreditation body. 
3. After being designated, the notified body sha ll update the docume ntation referred to 
in paragraph 2 whenever relevant change s occur in order to enable the national 
authority responsible for notified bodies  to monitor and verify continuous 
compliance with all the requirements set out in Annex VI.  
Article 32 
Assessment of the application 
1. The national authority responsible for notifie d bodies shall check that the application 
referred to in Article 31 is complete and draw up a preliminary assessment report.  
2. It shall submit the preliminary assessmen t report to the Commission which shall 
immediately transmit it to the Medical De vice Coordination Group established by 
Article 78 (‘MDCG’). Upon request by the Commission, the report shall be 
submitted by the authority in up to three official Union languages.  
3. Within 14 days of the submission referred to in paragraph 2, the Commission shall 
designate a joint assessment team made up of  at least two experts chosen from a list 
of experts who are qualifie d in the assessment of conf ormity assessment bodies. The 
list shall be drawn up by the Commission in  cooperation with the MDCG. At least 
one of these experts shall be a representa tive of the Commission who shall lead the 
joint assessment team. 
4. Within 90 days after designation of the jo int assessment team, the national authority 
responsible for notified bodies and the jo int assessment team shall review the 
documentation submitted with the application in accordance with Article 31 and conduct an on-site assessmen t of the applicant conformity assessment body and, 
where relevant, of any subsidiary or sub- contractor, located in side or outside the 
Union, to be involved in the conformity a ssessment process. Such on-site assessment 
shall not cover requirements for which the applicant conf ormity assessment body has 
received a certificate delivered by the national accreditation body as referred to in 
Article 31(2), unless the Commission repres entative mentioned in Article 32(3) 
requests the on-site assessment.  
Findings regarding non-compliance of a body with the requirement s set out in Annex 
VI shall be raised during the assessment  process and discussed between the national 
authority responsible for notif ied bodies and the joint assessm ent team with a view to 
finding common agreement with respect to the assessment of the application.  
EN 58   EN Divergent opinions shall be identified in the assessment report of the national 
authority responsible. 
5. The national authority responsible for not ified bodies shall submit its assessment 
report and its draft notification to the Commission which shall immediately transmit those documents to the MDCG and to the members of the joint assessment team. Upon request by the Commission, those documents shall be submitted by the authority in up to three o fficial Union languages.  
6. The joint assessment team shall provide its opinion regarding the assessment report 
and the draft notification within 21 days  of receipt of those documents and the 
Commission shall immediately submit this  opinion to the MDCG. Within 21 days 
after receipt of the opinion of the joint assessment team, the MDCG shall issue a 
recommendation with regard to the draft notification which the relevant national 
authority shall duly take into considerati on for its decision on the designation of the 
notified body. 
7. The Commission may, by means of implementi ng acts, adopt measures setting out 
the modalities for the application for notifi cation referred to in Article 31 and the 
assessment of the application set out in this  Article. Those implem enting acts shall be 
adopted in accordance with the examination procedure refe rred to in Article 88(3). 
Article 33 
Notification procedure 
1. Member States shall notify the Commission and the other Member States of the 
conformity assessment bodies they have desi gnated, using the elec tronic notification 
tool developed and managed by the Commission. 
2. Member States may notify only conformity assessment bodies which satisfy the 
requirements set out in Annex VI.  
3. Where a national authority responsible fo r notified bodies is  responsible for 
designation of notified bodies in  the field of products othe r than medical devices, the 
competent authority for medical devices sh all provide, prior to the notification, a 
positive opinion on the notification and its scope.  
4. The notification shall clearly specify th e scope of the desi gnation indicating the 
conformity assessment activities, the confor mity assessment procedures and the type 
of devices which the notified body is authorised to assess.  
The Commission may, by means of implementi ng acts, set up a list of codes and the 
corresponding types of devices to define the scope of the designation of notified 
bodies which the Member States shall indicate in their notification. Those 
implementing acts shall be adopted in ac cordance with the a dvisory procedure 
referred to in Article 88(2). 
5. The notification shall be accompanied by the final assessment report of the national 
authority responsible for no tified bodies, the opinion of  the joint assessment team 
and the recommendation of the MDCG. Wher e the notifying Member State does not  
EN 59   EN follow the recommendation of the MDCG, it shall provide a duly substantiated 
justification. 
6. The notifying Member State shall provide  the Commission and the other Member 
States with documentary evidence regarding the arrangements in place to ensure that 
the notified body will be monitored regula rly and will continue to satisfy the 
requirements set out in Annex VI. It sh all furthermore submit evidence of the 
availability of competent personnel for monitoring the notified body in accordance 
with Article 28(6). 
7. Within 28 days of a notification, a Memb er State or the Commission may raise 
written objections, setting out its arguments,  with regard either to the notified body 
or to its monitoring by the national au thority responsible for notified bodies. 
8. When a Member State or the Commission ra ises objections in accordance with 
paragraph 7, the effect of the notificati on shall be suspended. In this case, the 
Commission shall bring the matter before the MDCG within 15 days after expiry of the period referred to in paragraph 7. Af ter consulting the parties involved, the 
MDCG shall give its opinion at the latest  within 28 days afte r the matter has been 
brought before it. If the notifying Member State does not agree with the opinion of 
the MDCG, it may request the Commission to give its opinion.  
9. Where no objection is raised in accordance with paragraph 7 or where the MDCG or 
the Commission, after having been consulted in accordance with paragraph 8, is of the opinion that the notification may be accep ted fully or partially, the Commission 
shall publish the notification accordingly.  
10. The notification shall become valid the day after its public ation in the database of 
notified bodies developed and mana ged by the Commission. The published 
notification shall determine the scope of lawful activity of the notified body.  
Article 34 
Identification number and list of notified bodies 
1. The Commission shall assign an identification number to each notified body for 
which the notification is accepted in accord ance with Article 33. It shall assign a 
single identification number even when the body is notified under several Union acts. 
2. The Commission shall make the list of th e bodies notified unde r this Regulation, 
including the identification numbers that  have been assigned to them and the 
activities for which they have been notified, accessible to the public. The Commission shall ensure that th e list is kept up to date. 
Article 35 
Monitoring of notified bodies 
1. The national authority responsible for notif ied bodies shall con tinuously monitor the 
notified bodies to en sure ongoing compliance with the requirements set out in Annex 
VI. The notified bodies sha ll, on request, supply all relevant information and 
documents, required to enable the authority to verify compliance with those criteria.  
EN 60   EN Notified bodies shall, without delay, inform  the national authority responsible for 
notified bodies of any changes,  in particular regarding their personnel, facilities, 
subsidiaries or subcontractors, which may affect compliance with the requirements 
set out in Annex VI or their ability to conduct the conformity assessment procedures 
relating to the devices for whic h they have been designated. 
2. Notified bodies shall respond without dela y to requests relating to conformity 
assessments they have carried out, submitted by their or another Member State's authority or by the Commission. The nationa l authority responsible for notified 
bodies of the Member State in which the body is established sha ll enforce requests 
submitted by authorities of any other Me mber State or by the Commission unless 
there is a legitimate reason for not doing so  in which case both sides may consult the 
MDCG. The notified body or their national au thority responsible for notified bodies 
may request that any information transmitte d to the authorities of another Member 
State or to the Commission shall be treated confidential. 
3. At least once a year, the nati onal authority responsible fo r notified bodies shall assess 
whether each notified body under it s responsibility still satisfi es the requirements set 
out in Annex VI. This assessment shall incl ude an on-site visit to each notified body.  
4. Three years after notification of a no tified body, and again every third year 
thereafter, the assessment to determine whether the notified body still satisfies the requirements set out in Annex VI shall be conducted by the national authority 
responsible for notified bodies  of the Member State in which the body is established 
and a joint assessment team designated in accordance with the procedure described 
in Article 32(3) and (4). At the request of  the Commission or of a Member State, the 
MDCG may initiate the assessment process de scribed in this paragraph at any time 
when there is reasonable concern about  the ongoing compliance of a notified body 
with the requirements set out in Annex VI. 
5. The Member States shall report to the Commission and to the other Member States, 
at least once a year, on their monitoring activities. This report shall contain a 
summary which shall be made publicly available. 
Article 36 
Changes to notifications 
1. The Commission and the other Member States shall be no tified of any subsequent 
relevant changes to the notification. The pr ocedures described in Article 32(2) to (6) 
and in Article 33 shall apply to changes wher e they entail an extension of the scope 
of the notification. In al l other cases, the Commissi on shall immediately publish the 
amended notification in the electronic notifica tion tool referred to in Article 33(10). 
2. Where a national authority responsible for notified bodies has ascertained that a 
notified body no longer meets the requirements set out in Annex VI, or that it is 
failing to fulfil its obligations, the author ity shall suspend, restrict, or fully or 
partially withdraw the notif ication, depending on the seri ousness of the failure to 
meet those requirements or fulfil those ob ligations. A suspension shall not exceed a 
period of one year, renewable once for th e same period. Where the notified body has  
EN 61   EN ceased its activity, the national authorit y responsible for notified bodies shall 
withdraw the notification.  
The national authority responsible for notif ied bodies shall immediately inform the 
Commission and the other Member States  of any suspension, restriction or 
withdrawal of a notification. 
3. In the event of restriction, suspension or withdrawal of a notification, the Member 
State shall take appropriat e steps to ensure that th e files of the notified body 
concerned are either processed by another notified body or kept available for the 
national authorities responsible for notifie d bodies and for market surveillance at 
their request.  
4. The national authority res ponsible for notified bodies shall assess whether the 
reasons which gave rise to the change to the notification have an impact on the 
certificates issued by the notified body and, within three months after having notified 
the changes to the notific ation, shall submit a repor t on its findings to the 
Commission and the other Member States. Where necessary to ensure the safety of devices on the market, that authority shal l instruct the notifie d body to suspend or 
withdraw, within a reasona ble period of time determined by the authority, any 
certificates which were unduly i ssued. If the notified body fails to do so within the 
determined period of time, or has ceas ed its activity, the national authority 
responsible for notified bodies itself sha ll suspend or withdraw the certificates 
unduly issued. 
5. The certificates, other than those unduly i ssued, which were issued by the notified 
body for which the notification has been su spended, restricted or withdrawn shall 
remain valid in the following circumstances: 
(a) in the case of suspension of a notification: on condition that, within three 
months of the suspension, either the competent authority for medical devices of 
the Member State in which the manufact urer of the device covered by the 
certificate is established, or another no tified body confirm in writing that it is 
assuming the functions of the notified body during the period of suspension; 
(b) in the case of restriction or withdrawal of a notificat ion: for a period of three 
months after the restriction or withdraw al. The competent authority for medical 
devices of the Member State in which the manufacturer of the device covered 
by the certificate is established may extend  the validity of the certificates for 
further periods of three months, whic h altogether may not exceed twelve 
months, provided it is assuming the func tions of the notified body during this 
period. 
The authority or the notified body assu ming the functions of the notified body 
affected by the change of notification sh all immediately inform the Commission, the 
other Member States and the other notified bodies thereof.  
EN 62   EN Article 37 
Challenge to the competence of notified bodies 
1. The Commission shall investig ate all cases where concerns have been brought to its 
attention regarding the continued fulfilm ent by a notified body of the requirements 
set out in Annex VI or the obligations to which it is subject. It may also commence 
such investigations on its own initiative.  
2. The notifying Member State shall provide  the Commission, on request, with all 
information regarding the notifica tion of the notified body concerned.  
3. Where the Commission ascertains that  a notified body no longer meets the 
requirements for its notification, it shal l inform the notifying Member State 
accordingly and request it to take the n ecessary corrective measures, including the 
suspension, restriction or withdrawal of the notification if necessary.  
Where the Member State fails to take the necessary corrective measures, the 
Commission may, by means of implementing act s, suspend, restrict or withdraw the 
notification. Those implementing acts sh all be adopted in accordance with the 
examination procedure referred to in Article  88(3). It shall notify the Member State 
concerned of its decision and update th e database and list of notified bodies.  
Article 38 
Exchange of experience between national aut horities responsible for notified bodies 
The Commission shall provide for the organi sation of exchange of experience and 
coordination of administrative practice betwee n the national authorities responsible for 
notified bodies under this Regulation. 
Article 39 
Coordination of notified bodies 
The Commission shall ensure that appropriate  coordination and coope ration between notified 
bodies is put in place and opera ted in the form of a coordina tion group of notified bodies in 
the field of medical devices, including in vitro diagnostic medical devices. 
The bodies notified under this Regulation shall participate in the work of that group. 
Article 40 
Fees 
1. The Member State where the bodies are es tablished shall levy fees on applicant 
conformity assessment bodies and on notifie d bodies. These fees shall, wholly or 
partly, cover the costs relati ng to the activities exercised by the national authorities 
responsible for notified bodies in accordance with this Regulation. 
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 89 setting out the structure and the leve l of the fees referred to in paragraph 1, 
taking into account the objectives of protec tion of human health  and safety, support  
EN 63   EN of innovation and cost-effectivene ss. Particular attention shal l be paid to the interests 
of notified bodies that submitted a valid  certificate delivered by the national 
accreditation body as referred to in Article 31(2) and notified bodies that are small 
and medium-sized enterprises as defined by Commission Recommendation 
2003/361/EC.  
Chapter V 
Classification and conformity assessment 
SECTION 1 – CLASSIFICATION  
Article 41 
Classification of medical devices 
1. Devices shall be divided into classes I, IIa, IIb and III, taki ng into account their 
intended purpose and inherent risks. Classi fication shall be carried out in accordance 
with the classification criter ia set out in Annex VII.  
2. Any dispute between the manufacturer and the notified body con cerned, arising from 
the application of the classi fication criteria, shall be re ferred for a decision to the 
competent authority of the Member State where the manufacturer has his registered 
place of business. In cases where the ma nufacturer has no registered place of 
business in the Union and has not yet design ated an authorised representative, the 
matter shall be referred to the competent authority of the Member State where the authorised representative referred to in the last indent of point (b) of Section 3.2. of 
Annex VIII has his registered place of business.  
At least 14 days prior to any decision, the competent author ity shall notify the 
MDCG and the Commission of its envisaged decision. 
3. The Commission may, at the request of a Me mber State or on its own initiative, by 
means of implementing acts, decide on the application of the classification criteria 
set out in Annex VII to a given device, or category or group of devices, with a view 
to determining their classification.  
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to in Article 88(3). 
4. In the light of technical pr ogress and any information whic h becomes available in the 
course of the vigilance and market survei llance activities described in Articles 61 to 
75, the Commission shall be empowered to adopt delegated acts in accordance with 
Article 89 as regards the following:  
(a) deciding that a device, or category or group of devices, should, by way of 
derogation from the classification criteria set out in Annex VII, be classified in 
another class;  
(b) amending or supplementing the classificat ion criteria set out in Annex VII.  
EN 64   EN SECTION 2 – CONFORMITY ASSESSMENT  
Article 42 
Conformity assessment procedures 
1. Prior to placing a device on the market, manufacturers shall undertake an assessment 
of the conformity of that device. The conf ormity assessment procedures are set out in 
Annexes VIII to XI. 
2. Manufacturers of devices classified as class III, other than custom-made or 
investigational devices, sha ll be subject to a conformity assessment based on full 
quality assurance and design dossier exam ination as specified in Annex VIII. 
Alternatively, the manufacturer may choose to apply a conformity assessment based 
on type examination as specified in Annex IX coupled with a conformity assessment 
based on product conformity verification as specified in Annex X.  
In the case of devices referred to in the fi rst subparagraph of Article 1(4), the notified 
body shall follow the consultation procedure as specified in Section 6.1 of Chapter II of Annex VIII or Section 6 of  Annex IX, as applicable. 
In the case of devices that are covered by this Regulation in accordance with point 
(e) of Article 1(2), the no tified body shall follow the consultation procedure as 
specified in Section 6.2 of Chapter II of Annex VIII or Section 6 of Annex IX, as 
applicable. 
3. Manufacturers of devices classified as class IIb, other than custom-made or 
investigational devices, sha ll be subject to a conformity assessment based on full 
quality assurance as specified in Anne x VIII, except for its Chapter II, with 
assessment of the design documentation wi thin the technical documentation on a 
representative basis. A lternatively, the manufacturer may choose to apply a 
conformity assessment based on type examination as specified in Annex IX coupled with a conformity assessment based on produ ct conformity verification as specified 
in Annex X. 
4. Manufacturers of devices classified as class IIa, other than custom-made or 
investigational devices, sha ll be subject to a conformity assessment based on full 
quality assurance as specified in Anne x VIII, except for its Chapter II, with 
assessment of the design documentation wi thin the technical documentation on a 
representative basis. Alte rnatively, the manufacturer may choose to draw up the 
technical documentation set out in Annex II coupled with a conformity assessment 
based on product conformity verification as specified in Section 7 of Part A or 
Section 8 of Part B of Annex X. 
5. Manufacturers of devices classified as class I, other than custom-made or 
investigational devices, shall declare the conformity of their products by issuing the 
EU declaration of conformity referred to in Article 17 after drawing up the technical 
documentation set out in Annex II. If the devi ces are placed on the market in sterile 
condition or have a measuring function, the manufacturer shall apply the procedures  
EN 65   EN set out in Annex VIII, except for its Chapter II, or in Part A of Annex X. However, 
involvement of the notified body shall be limited:  
(a) in the case of devices placed on the market  in sterile condition, to the aspects of 
manufacture concerned with securing  and maintaining sterile conditions, 
(b) in the case of devices with a measuring function, to the aspects of manufacture 
concerned with the conformity of the devices with the metrological 
requirements. 
6. Manufacturers may choose to apply a confor mity assessment procedure applicable to 
devices of a higher class th an the device in question. 
7. Manufacturers of custom-made devices shall follow the procedur e set out in Annex 
XI and draw up the statement set out in that Annex before placing the device on the market. 
8. The Member State in which the notified body is established may determine that all or 
certain documents, including the technica l documentation, audit, assessment and 
inspection reports, relating to th e procedures referred to in paragraphs 1 to 6 shall be 
available in an official Union language. Otherwise they shall be available in an 
official Union language accep table to the notified body.  
9. Investigational devices shall be subject to the requirements set out  in Articles 50 to 
60. 
10. The Commission may, by means of implementing acts, specify the modalities and 
the procedural aspects with a view to  ensuring harmonised application of the 
conformity assessment procedures by the notified bodies for any of the following 
aspects:  
– the frequency and the sampling basis of the assessment of the design 
documentation within the technical documentation on a representative basis as set out in Sections 3.3(c) and 4.5 of A nnex VIII in the case of devices of 
classes IIa and IIb, and in Section 7.2 of  Part A of Annex X in the case of 
devices of class IIa;  
– the minimum frequency of unannounced f actory inspections and sample checks 
to be conducted by notified bodies in  accordance with Section 4.4 of Annex 
VIII, taking into account the risk -class and the type of device; 
– the physical, laboratory or ot her tests to be carried out  by notified bodies in the 
context of sample checks, design dossier  examination and type examination in 
accordance with Sections 4.4 and 5.3 of Annex VIII, Section 3 of Annex IX 
and Section 5 of Part B of Annex X. 
Those implementing acts shall be adopted  in accordance with the examination 
procedure referred to in Article 88(3). 
11. In the light of technical pr ogress and any information whic h becomes available in the 
course of the designat ion or monitoring of not ified bodies set out in Articles 28  to 40, 
or of the vigilance and market surveillan ce activities described in Articles 61 to 75,  
EN 66   EN the Commission shall be empowered to a dopt delegated acts in accordance with 
Article 89 amending or supplementing the conf ormity assessment procedures set out 
in Annexes VIII to XI. 
Article 43 
Involvement of notified bodies 
1. Where the conformity assessment procedur e requires the involve ment of a notified 
body, the manufacturer may apply to a notifie d body of his choice, provided that the 
body is notified for the conformity assessmen t activities, the c onformity assessment 
procedures and the devices concerned. An a pplication may not be lodged in parallel 
with more than one notified body for the same conformity assessment activity.  
2. The notified body concerned shall inform  the other notifie d bodies of any 
manufacturer who withdraws his applica tion prior to the notified body's decision 
regarding the conformity assessment.  
3. The notified body may require any informati on or data from the manufacturer which 
is necessary in order to properly conduct the chosen conformity assessment procedure. 
4. Notified bodies and the personne l of notified bodies shall carry out their conformity 
assessment activities with the highest de gree of professional integrity and the 
requisite technical competence in the spec ific field and shall be free from all 
pressures and inducements, particularly financial, which might influence their 
judgement or the results of their conform ity assessment activitie s, especially as 
regards persons or groups with an interest  in the results of those activities.  
Article 44 
Mechanism for scrutiny of certa in conformity assessments 
1. Notified bodies shall notify the Commissi on of applications for conformity 
assessments for devices classified as class II I, with the exception of applications to 
supplement or renew existing certificates. The notification shall be accompanied by 
the draft instructions for use referred to  in Section 19.3 of A nnex I and the draft 
summary of safety and clinical performa nce referred to in Article 26. In its 
notification the notified body shall indica te the estimated date by which the 
conformity assessment is  to be completed. The Commission shall immediately 
transmit the notification and the acco mpanying documents to the MDCG.  
2. Within 28 days of receipt of the informa tion referred to in paragraph 1, the MDCG 
may request the notified body to submit a su mmary of the preliminary conformity 
assessment prior to issuing a certificate. Upon suggestion by any of its members or 
by the Commission, the MDCG shall decide on making such request in accordance with the procedure set out in Article 78(4) . In its request the MDCG shall indicate 
the scientifically valid health reason for having selected the specific file for submission of a summary of the preliminar y conformity assessment. When selecting 
a specific file for submission, the principle of  equal treatment shall be duly taken into 
account.   
EN 67   EN Within 5 days after receipt of the re quest by the MDCG, the notified body shall 
inform the manufacturer thereof.  
3. The MDCG may submit comments on the summary of the preliminary conformity 
assessment at the latest 60 days after subm ission of this summary. Within that period 
and at the latest 30 days after submission, the MDCG ma y request the submission of 
additional information that for scientific ally valid grounds are necessary for the 
analysis of the notified body's preliminary conformity assessment. This may include 
a request for samples or an on-site vis it to the manufacturer's premises. Until 
submission of the additional information re quested, the period for comments referred 
to in the first sentence of  this subparagraph shall be suspended. Subsequent requests 
for additional information from the MDCG shall not suspend the period for the submission of comments. 
4. The notified body shall give due consid eration to any comments received in 
accordance with paragraph 3. It shall conve y to the Commission an explanation of 
how they have been taken into considera tion, including any due justification for not 
following the comments received, and its fi nal decision regarding the conformity 
assessment in question. The Commission shal l immediately transmit this information 
to the MDCG.  
5. Where deemed necessary for the protection of patient safety and public health, the 
Commission, may determine, by means of impl ementing acts, specif ic categories or 
groups of devices, other than devices of clas s III, to which paragraphs 1 to 4 shall 
apply during a predefined period of time. Those implementing acts shall be adopted in accordance with the examination pr ocedure referred to in Article 88(3). 
Measures pursuant to this paragraph may be justified only by one or more of the 
following criteria: 
(a) the novelty of the device or of the technology on which it is based and the 
significant clinical or public health impact thereof; 
(b) an adverse change in the risk-benefit pr ofile of a specific category or group of 
devices due to scientifically  valid health concerns in  respect of components or 
source material or in respect of the impact on health in case of failure;  
(c) an increased rate of serious incidents reported in accordance with Article 61 in 
respect of a specific category or group of devices; 
(d) significant discrepancies in the conform ity assessments carried out by different 
notified bodies on substantially similar devices;  
(e) public health concerns regarding a specifi c category or group of devices or the 
technology on which they are based. 
6. The Commission shall make a summary of the comments submitted in accordance 
with paragraph 3 and the outcome of the conformity assessment procedure accessible 
to the public. It shall not disclose any pers onal data or information of commercially 
confidential nature.  
EN 68   EN 7. The Commission shall set up the technical in frastructure for the data-exchange by an 
electronic means betwee n notified bodies and MDCG for th e purposes of this Article.  
8. The Commission, by means of implementing acts, may adopt the modalities and the 
procedural aspects concerning the submi ssion and analysis of the summary of the 
preliminary conformity assessment in acco rdance with paragraphs 2 and 3. Those 
implementing acts shall be adopted in acc ordance with the ex amination procedure 
referred to in Article 88(3).  
Article 45 
Certificates 
1. The certificates issued by th e notified bodies in accordance  with Annexes VIII, IX 
and X shall be in an official Union langua ge determined by the Member State in 
which the notified body is established or otherwise in an official Union language 
acceptable to the notified body. The minimum cont ent of the certificates is set out in 
Annex XII.  
2. The certificates shall be valid for the peri od they indicate, which shall not exceed 
five years. On application by the manufactur er, the validity of th e certificate may be 
extended for further periods, each not exceed ing five years, based on a re-assessment 
in accordance with the applicable conf ormity assessment procedures. Any 
supplement to a certificate sh all remain valid as long as  the certificate which it 
supplements is valid. 
3. Where a notified body finds that requirements of this Regulation are no longer met 
by the manufacturer, it shall, taking account  of the principle of proportionality, 
suspend or withdraw the certificate issu ed or impose any restrictions on it unless 
compliance with such requirements is ensure d by appropriate corr ective action taken 
by the manufacturer within an appropria te deadline set by the notified body. The 
notified body shall give the reasons for its decision. 
4. The Commission, in collaboration with the Member States, shall set up and manage 
an electronic system to collate and pro cess information on certificates issued by 
notified bodies. The notified body shall enter into this electronic system information 
regarding certificates issued, including am endments and supplements, and regarding 
suspended, reinstated, withdrawn or refused certificates and rest rictions imposed on 
certificates. This information sh all be accessible to the public. 
5. In the light of technical progress, the Commission shall be empowered to adopt 
delegated acts in accordance with Article 89 amending or supplementing the minimum content of the certificat es set out in Annex XII.  
Article 46 
Voluntary change of notified body 
1. In cases where a manufacturer terminates his contract with a notified body and enters 
into a contract with another notified body in  respect of the conformity assessment of 
the same device, the modaliti es of the change of no tified body shall be clearly 
defined in an agreement between the ma nufacturer, the outgoing notified body and  
EN 69   EN the incoming notified body. This agreement shall address at least the following 
aspects:  
(a) the date of invalidity of certificat es issued by the outgoing notified body; 
(b) the date until which the identificati on number of the outgoing notified body 
may be indicated in the information supplied by the manufacturer, including 
any promotional material;  
(c) the transfer of documents, including conf identiality aspects and property rights; 
(d) the date as of which the incoming notif ied body assumes full responsibility for 
the conformity assessment tasks. 
2. On their date of invalidit y, the outgoing notified body shal l withdraw th e certificates 
it has issued for the device concerned. 
Article 47 
Derogation from the conform ity assessment procedures 
1. By way of derogation from Article 42, any competent authority may authorise, on 
duly justified request, the placing on the mark et or putting into service within the 
territory of the Member State concerne d, of a specific device for which the 
procedures referred to in Artic le 42 have not been  carried out and use of which is in 
the interest of public hea lth or patient safety.  
2. The Member State shall inform the Commi ssion and the other Member States of any 
decision to authorise the placing on the market  or putting into service of a device in 
accordance with paragraph 1 where such aut horisation is granted for use other than 
for a single patient. 
3. Upon request by a Member State and where this is in the in terest of public health or 
patient safety in more than one Member  State, the Commission may, by means of 
implementing acts, extend for a determined period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 to the 
territory of the Union and set the conditions  under which the device may be placed 
on the market or put into service. Thos e implementing acts shall be adopted in 
accordance with the examination proce dure referred to in Article 88(3). 
On duly justified imperative grounds of urgenc y relating to the heal th and safety of 
humans, the Commission shall adopt immedi ately applicable implementing acts in 
accordance with the procedure referred to in Article 88(4). 
Article 48 
Certificate of free sale 
1. For the purpose of export and upon request by a manufacturer, the Member State in 
which the manufacturer has its registered place of business shall issue a certificate of 
free sale declaring that the manufacturer is properly established and that the device in 
question bearing the CE-marking in accordan ce with this Regulat ion may be legally  
EN 70   EN marketed in the Union. The certificate of free sale shall be valid for the period 
indicated on it which shall not exceed five  years and shall not exceed the validity of 
the certificate referred to  in Article 45 issued for the device in question.  
2. The Commission may, by means of implem enting acts, establish a model for 
certificates of free sale taking into account international practice as regards the use of 
certificates of free sale. Those implementing acts shall be adopted in accordance with 
the advisory procedure refe rred to in Article 88(2). 
Chapter VI 
Clinical evaluation and c linical investigations  
Article 49 
Clinical evaluation  
1. Manufacturers shall conduct a clinical eval uation in accordance with the principles 
set out in this Article and Part A of Annex XIII.  
2. A clinical evaluation shall follow a defi ned and methodologically sound procedure 
based on either of the following: 
(a) a critical evaluation of the relevant sc ientific literature currently available 
relating to the safety, performance, de sign characteristics and intended purpose 
of the device, where the follo wing conditions are satisfied: 
– it is demonstrated that the device s ubject to clinical evaluation and the 
device to which the data relate are equivalent,  
– the data adequately demonstrate compliance with the relevant general 
safety and performance requirements; 
(b) a critical evaluation of the results of all clinical investigations performed in 
accordance with Articles 50 to 60 and Annex XIV; 
(c) a critical evaluation of the combined clin ical data referred to in points (a) and 
(b). 
3. Where demonstration of conformity w ith general safety and performance 
requirements based on clinical data is not deemed appropriate, ad equate justification 
for any such exception shall be given based on the results of th e manufacturer's risk 
management and on consideration of the specifics of the interaction between the device and the human body, the clinical perfor mances intended and the claims of the 
manufacturer. The adequacy of demonstrati on of conformity with the general safety 
and performance requirements based on the results of non-clinic al testing methods 
alone, including performance evaluation, be nch testing and pre- clinical evaluation, 
has to be duly substantiate d in the technical documenta tion referred to in Annex II.  
EN 71   EN 4. The clinical evaluation and its documentation shall be updated throughout the life 
cycle of the device concerned with data obtained from the implementation of the 
manufacturer's post-market surveillan ce plan referred to in Article 8(6). 
5. The clinical evaluation and its outcome sha ll be documented in a clinical evaluation 
report referred to in Section 6 of Part A of Annex XIII which shall be included or fully referenced in the technical documenta tion referred to in A nnex II relating to the 
device concerned. 
Article 50 
General requirements regardi ng clinical investigations 
1. Clinical investigations shall be subject to Articles 50-60 and Annex XIV if they are 
conducted for one or more of the following purposes:  
(a) to verify that, under normal conditions of use, devices are designed, 
manufactured and packaged in such a way that they are suitable for one or more of the specific purposes of a medical  device referred to in number (1) of 
Article 2(1), and achieve the perfor mances intended as specified by the 
manufacturer; 
(b) to verify that devices achieve the intended benefits to the patient as specified 
by the manufacturer; 
(c) to determine any undesirable side-effect s, under normal conditions of use, and 
assess whether they constitute acceptable risks when weighed against the benefits to be achieved by the device.  
2. Where the sponsor is not established in th e Union, he shall ensure that a contact 
person is established in the Union. That co ntact person shall be the addressee for all 
communications with the sponsor provided for in this Regulation. Any communication to that contact person shal l be considered as communication to the 
sponsor. 
3. Clinical investigations shall be designe d and conducted in a way that the rights, 
safety and well-being of the subjects participating in a clinical investigation are 
protected and that the clinical  data generated in the clinical investigation are going to 
be reliable and robust.  
4. Clinical investigations shall be desi gned, conducted, recorded and reported in 
accordance with the provisions of Arti cles 50 to 60 and of Annex XIV.  
Article 51 
Application for clinical investigations 
1. Before making the first application, the sponsor shall procure from the electronic 
system referred to in Article 53 a single identification number for a clinical investigation conducted in one site or multiple  sites, in one or more than one Member 
State. The sponsor shall use this single identification number wh en registering the 
clinical investigation in  accordance with Article 52.  
EN 72   EN 2. The sponsor of a clinical investigation sh all submit an application to the Member 
State(s) in which the investigation is to be conducted accompanied by the documentation referred to in Chapter II of A nnex XIV. Within six days after receipt 
of the application, the Member State concerned shall notify the sponsor whether the clinical investigation falls within the scope of this Regulation and whether the 
application is complete.  
Where the Member State has not notified the sponsor within the time period referred 
to in the first subparagraph, the clinical i nvestigation shall be c onsidered as falling 
within the scope of this Re gulation and the application sh all be considered complete. 
3. Where the Member State finds that the clinical investigation applied for does not fall 
within the scope of this Regulation or that the application is not complete, it shall inform the sponsor thereof and shall set a maximum of six days for the sponsor to comment or to complete the application.  
Where the sponsor has not provided comments  nor completed the application within 
the time-period referred to in the firs t subparagraph, the application shall be 
considered as withdrawn.  
Where the Member State has not notified the sponsor according to paragraph 2 
within three days following receipt of the co mments or of the completed application, 
the clinical investigation shall be consider ed as falling within the scope of this 
Regulation and the application sh all be considered complete. 
4. For the purposes of this Chapter, the da te on which the spons or is notified in 
accordance with paragraph 2 shall be the va lidation date of the application. Where 
the sponsor is not notif ied, the validation date shall be the last day of the time periods 
referred to in paragraphs 2 and 3. 
5. The sponsor may start the c linical investigation in th e following circumstances:  
(a) in the case of investigational devices clas sified as class III and implantable or 
long-term invasive devices classified as class IIa or IIb, as soon as the Member 
State concerned has notified the sponsor of its approval; 
(b) in the case of investigational devices ot her than those referred to in point (a) 
immediately after the date of applica tion provided that the Member State 
concerned has so decided and that eviden ce is provided that the rights, safety 
and well-being of the subjects to the c linical investigati on are protected; 
(c) after the expiry of 35 days after the valid ation date referred to in paragraph 4, 
unless the Member State concerned has no tified the sponsor w ithin that period 
of its refusal based on considerations of  public health, patient safety or public 
policy.  
6. Member States shall ensure that the pers ons assessing the application do not have 
conflicts of interest and that they are inde pendent of the sponsor, the institution of the 
investigation site(s) and the investigators involved, as well as free of any other undue 
influence.   
EN 73   EN Member States shall ensure that the assessment is done jointly by a reasonable 
number of persons who collectively ha ve the necessary qualifications and 
experience. In the assessment, the view of at least one person whose primary area of 
interest is non-scientific shall be taken in to account. The view of at least one patient 
shall be taken into account. 
7. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 89 amending or supplementing, in th e light of technical progress and global 
regulatory developments, the requirements for the documentation to be submitted with the application for the clinical inves tigation that is laid down in Chapter II of 
Annex XIV. 
Article 52  
Registration of clinical investigations 
1. Before commencing the clinical investig ation, the sponsor shall enter in the 
electronic system referred to in Articl e 53 the following information regarding the 
clinical investigation:  
(a) the single identification number of the clinical investigation; 
(b) the name and contact details of the s ponsor and, if appli cable, his contact 
person established in the Union; 
(c) the name and contact details of the natu ral or legal person responsible for the 
manufacture of the investigational de vice, if different from the sponsor; 
(d) the description of the investigational device; 
(e) the description of the comp arator(s), if applicable; 
(f) the purpose of the clin ical investigation; 
(g) the status of the clin ical investigation.  
2. Within one week of any change occurring in relation to the information referred to in 
paragraph 1, the sponsor sha ll update the relevant data  in the electronic system 
referred to in Article 53. 
3. The information shall be accessible to th e public, through the electronic system 
referred to in Article 53, unless, for all or parts of that informa tion, confidentiality of 
the information is justified on any of the following grounds: 
(a) protection of personal data in accordance with Regulation (EC) No 45/2001; 
(b) protection of commercially  sensitive information; 
(c) effective supervision of th e conduct of the c linical investigat ion by the Member 
State(s) concerned.  
EN 74   EN 4. No personal data of subjects participating in  clinical investigations shall be publicly 
available. 
Article 53 
Electronic system on clinical investigations 
1. The Commission shall, in collaboration w ith the Member States, set up and manage 
an electronic system to create the single identification numbers for clinical investigations referred to in Article 51( 1) and to collate and process the following 
information:  
(a) the registration of clinical investig ations in accordance with Article 52; 
(b) the exchange of information between th e Member States and between them and 
the Commission in accordance with Article 56; 
(c) the information related to clinical inve stigations conducted in more than one 
Member State in case of a single appl ication in accordance with Article 58; 
(d) reports on serious adverse events and devi ce deficiencies referred to in Article 
59(2) in case of a single applica tion in accordance with Article 58.  
2. When setting up the electronic system referred in paragraph 1, the Commission shall 
ensure that it is interoperable with the EU  database for clinical trials on medicinal 
products for human use set up in accordance with Article […] of Regulation (EU) No 
[…/…]. With the exception of the info rmation referred to in Article 52, the 
information collated and processed in the el ectronic system shal l be accessible only 
to the Member States and to the Commission.  
3. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 89 determining which other inform ation regarding clinic al investigations 
collated and processed in the electronic sy stem shall be publicly  accessible to allow 
interoperability with the EU database for clinical trials on medicinal products for 
human use set up by Regulation (EU) No [… /…]. Article 52(3) and (4) shall apply. 
Article 54 
Clinical investigations with devices  authorised to bear the CE marking 
1. Where a clinical investigation is to be conducted to further assess a device which is 
authorised in accordance with Article 42 to bear the CE marking and within its 
intended purpose referred to in the rele vant conformity assessment procedure, 
hereinafter referred to as ‘post-market c linical follow-up investigation’, the sponsor 
shall notify the Member States concerned at least 30 days prior to their commencement if the investigation would subm it subjects to additionally invasive or 
burdensome procedures. Article 50(1) to (3), Article 52, Article 55, Article 56(1), 
Article 57(1), the first subpara graph of Article 57(2) and the relevant provisions of 
Annex XIV shall apply.  
2. If the aim of the clinical investigation regarding a devi ce which is authorised in 
accordance with Article 42 to bear the CE marking is to  assess such device for a  
EN 75   EN purpose other than that referred to in the information supplied by the manufacturer in 
accordance with Section 19 of Annex I and in the relevant conformity assessment 
procedure, Articles 50 to 60 shall apply. 
Article 55 
Substantial modifications to a clinical investigation 
1. If the sponsor introduces modifications to a clinical investigation that are likely to 
have a substantial impact on the safety or rights of the subjects or on the robustness 
or reliability of the clinical data genera ted by the investigati on, he shall notify the 
Member State(s) concerned of the reasons for and the content of those modifications. 
The notification shall be accompanied by an updated version of the relevant 
documentation referred to in Chapter II of Annex XIV. 
2. The sponsor may implement the modifications referred to in paragraph 1 at the 
earliest 30 days after notification, unless the Member State concerned has notified 
the sponsor of its refusal base d on considerations of public  health, patient safety or 
public policy. 
Article 56 
Information exchange betw een Member States 
1. Where a Member State has refused, suspended or terminated a clin ical investigation, 
or has called for a substantial modifica tion or temporary halt of a clinical 
investigation, or has been notified by the sponsor of the early termination of a 
clinical investigation on safety grounds, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission by 
means of the electronic system  referred to in Article 53. 
2. Where an application is w ithdrawn by the sponsor prior to a decision by a Member 
State, that Member State shall inform  all the other Member States and the 
Commission of that fact, by means of the el ectronic system referred to in Article 53.  
Article 57 
Information by the sponsor in the event of temporary halt or  termination of a clinical 
investigation 
1. If the sponsor has temporarily halted a c linical investigation on safety grounds, he 
shall inform the Member States concerne d within 15 days of the temporary halt. 
2. The sponsor shall notify each Member Stat e concerned of the end of a clinical 
investigation in relation to that Member State, providing a justification in the event 
of early termination. That notification shall be made within 15 days from the end of 
the clinical investigation in relation to that Member State. 
If the investigation is conduc ted in more than one Memb er State the sponsor shall 
notify all Member States concerned of the overall end of the clinical investigation. 
That notification shall be made within 15 da ys from the overall end of the clinical 
investigation.  
EN 76   EN 3. Within one year from the end of the clini cal investigation, the s ponsor shall submit to 
the Member States concerned a summary of the results of the clinical investigation in form of a clinical investig ation report referred to in  Section 2.7 of Chapter I of 
Annex XIV. Where, for scien tific reasons, it is not possible to submit the clinical 
investigation report within one year, it shall be submitted as soon as it is available. In this case, the clinical investigation plan referred to in Secti on 3 of Chapter II of 
Annex XIV shall specify when the results of the clinical investigation are going to be submitted, together with an explanation.  
Article 58 
Clinical investigations conducted in more than one Member State 
1. By means of the electronic system referred to in Article 53, the s ponsor of a clinical 
investigation to be conducted in more th an one Member State may submit, for the 
purpose of Article 51, a single applica tion that, upon receipt, is transmitted 
electronically to the Member States concerned.  
2. In the single application, the sponsor shall propose one  of the Member States 
concerned as coordinating Memb er State. If that Member State does not wish to be 
the coordinating Member State, it shall agr ee, within six days of submission of the 
single application, with anothe r Member State concerned that  the latter shall be the 
coordinating Member State. If no other Memb er State accepts to be the coordinating 
Member State, the Member State proposed by the sponsor shall be the coordinating 
Member State. If another Member Stat e than the one proposed by the sponsor 
becomes coordinating Member State, the dead line referred to in Article 51(2) shall 
start on the day following the acceptance. 
3. Under the direction of the c oordinating Member State referr ed to in paragraph 2, the 
Member States concerned shall coordinate their assessment of the application, in 
particular of the documentation submitted in accordance with Chapter II of Annex XIV, except for Sections 3.1.3, 4.2, 4.3 and 4.4 thereof which shall be assessed 
separately by each Member State concerned.  
The coordinating Member State shall:  (a) within 6 days of receipt of the single application notify the sponsor whether the 
clinical investigation falls within the scope of this Regulation and whether the 
application is complete, except for th e documentation submitted in accordance 
with Sections 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XIV for which 
each Member State shall verify the comp leteness. Article 51(2) to (4) shall 
apply to the coordinating Member State in  relation to the verification that the 
clinical investigation falls within the scope of this Regulation and that the application is complete, except for the documentation submitted in accordance 
with Sections 3.1.3, 4.2, 4.3 and 4.4 of Chapte r II of Annex XIV. Article 51(2) 
to (4) shall apply to each Member State in relation to the verification that the 
documentation submitted in accordance with Sections 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XIV is complete;   
EN 77   EN (b) establish the results of the coordinated assessment in a report to be taken into 
account by the other Member States con cerned when deciding on the sponsor’s 
application in accordance with Article 51(5).  
4. The substantial modifications referred to in Article 55 shall be notified to the 
Member States concerned by means of the el ectronic system referred to in Article 53. 
Any assessment as to whether there are groun ds for refusal as referred to in Article 
55 shall be carried out under the direc tion of the coordinating Member State. 
5. For the purpose of Article 57 (3), the sponsor shall submit the clinical investigation 
report to the Member States concerned by m eans of the electronic system referred to 
in Article 53. 
6. The Commission shall provide secretarial s upport to the coordinating Member State 
in the accomplishment of its tasks provided for in this Chapter.  
Article 59 
Recording and reporting of events occurring during clinical investigations 
1. The sponsor shall fully record any of the following: 
(a) an adverse event identified in the clini cal investigation plan as critical to the 
evaluation of the results of the clinical investigation in view of the purposes 
referred to in Article 50(1);  
(b) a serious adverse event;  
(c) a device deficiency that might have led to a serious adverse event if suitable 
action had not been taken, intervention ha d not occurred, or circumstances had 
been less fortunate; 
(d) new findings in relation to any event referred to in points (a) to (c). 
2. The sponsor shall report to all Member States where a clinical investigation is 
conducted without delay any of the following: 
(a) a serious adverse event that has a causal  relationship with the investigational 
device, the comparator or the investig ation procedure or where such causal 
relationship is reasonably possible; 
(b) a device deficiency that might have led to a serious adverse event if suitable 
action had not been taken, intervention ha d not occurred, or circumstances had 
been less fortunate; 
(c) new findings in relation to any event referred to in points (a) to (b). 
The time period for reporting shall take acc ount of the severity of the event. Where 
necessary to ensure timely reporting, the sponsor may submit an initial incomplete report followed up by a complete report.  
EN 78   EN 3. The sponsor shall also report to the Member States con cerned any event referred to 
in paragraph 2 occurring in third countries  in which a clinical investigation is 
performed under the same clini cal investigation plan as the one applying to a clinical 
investigation covered by this Regulation.  
4. In the case of a clinical investigation for which the sponsor has used the single 
application referred to in Article 58, the s ponsor shall report any event as referred to 
in paragraph 2 by means of the electroni c system referred to in Article 53. Upon 
receipt, this report shall be transmitted electronically to all Member States concerned.  
Under the direction of the coordinating Member  State referred to in Article 58(2), the 
Member States shall coordinate their assessm ent of serious adverse events and device 
deficiencies to determine whether a clini cal investigation needs to be terminated, 
suspended, temporarily halted or modified. 
This paragraph shall not affect  the rights of the other Memb er States to perform their 
own evaluation and to adopt measures in accordance with this Regulation in order to ensure the protection of public health a nd patient safety. The coordinating Member 
State and the Commission shall be kept informed of the outcome of any such 
evaluation and the adoption of any such measures. 
5. In the case of post-market clinical follow- up investigations referred to in Article 
54(1), the provisions on vigilance contained in Articles 61 to 66 shall apply instead 
of this Article. 
Article 60 
Implementing acts 
The Commission may, by means of implementing acts, adopt the modalities and procedural 
aspects necessary for the implementation of  this Chapter as regards the following: 
(a) harmonised forms for the application fo r clinical investigations and their 
assessment as referred to in Articles 51 and 58, taking into account specific categories or groups of devices;  
(b) the functioning of the electronic sy stem referred to in Article 53; 
(c) harmonised forms for the notification of post-market clinical follow-up 
investigations as referred to in Article  54(1), and of substantial modifications 
as referred to in Article 55; 
(d) the exchange of information between Memb er States as referred to in Article 
56; 
(e) harmonised forms for the reporting of serious adverse events and device 
deficiencies as referred  to in Article 59;  
(f) the timelines for the reporting of serious adverse events and device 
deficiencies, taking into acc ount the severity of the ev ent to be reported as 
referred to in Article 59.   
EN 79   EN Those implementing acts shall be adopted in  accordance with the examination procedure 
referred to in Article 88(3). 
Chapter VII 
Vigilance and market surveillance 
SECTION 1 – VIGILANCE  
Article 61 
Reporting of incidents and field  safety corrective actions 
1. Manufacturers of devices othe r than custom-made or inve stigational devices, shall 
report through the electroni c system referred to in Article 62 the following: 
(a) any serious incident in respect of devi ces made available on the Union market;  
(b) any field safety corrective action in re spect of devices made available on the 
Union market, including any field safety corrective action undertaken in a third 
country in relation to a device which is also legally made available on the Union market if the reason for the field safety corrective action is not limited to the device made available in the third country. 
Manufacturers shall make the report referre d to in the first subparagraph without 
delay, and no later than 15 days after they  have become aware of the event and the 
causal relationship with their device or that such causal relationship is reasonably 
possible. The time period for reporting shal l take account of the severity of the 
incident. Where necessary to ensure timel y reporting, the ma nufacturer may submit 
an initial incomplete report followed up by a complete report. 
2. For similar serious incidents occurring with the same device or device type and for 
which the root cause has been identifie d or the field safety corrective action 
implemented, manufacturers may provide periodic summary reports instead of 
individual incident reports, on condition that the competent authorities referred to in 
points (a), (b) and (c) of Article 62(5) ha ve agreed with the manufacturer on the 
format, content and frequency of  the periodic summary reporting. 
3. The Member States shall take all appropr iate measures to encourage healthcare 
professionals, users and patien ts to report to their competent authorities suspected 
serious incidents referred to in point (a) of paragraph 1. They shall record such 
reports centrally at national level. Where a competent authority of a Member State 
obtains such reports, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident. The manufacturer shall ensure 
the appropriate follow-up.  
The Member States shall coordinate between  them the development of standard web-
based structured forms for reporting of serious incident s by healthcare professionals, 
users and patients.  
EN 80   EN 4. Manufacturers of custom-made devices shal l report any serious incidents and field 
safety corrective actions referred to in pa ragraph 1 to the competent authority of the 
Member State in which the device in question has been made available.  
Article 62 
Electronic system on vigilance  
1. The Commission shall, in collaboration w ith the Member States, set up and manage 
an electronic system to collate a nd process the following information:  
(a) the reports by manufacturers  on serious incidents an d field safety corrective 
actions referred to in Article 61(1);  
(b) the periodic summary reports by manufact urers referred to in Article 61(2); 
(c) the reports by competent au thorities on serious incidents referred to in the 
second subparagraph of Article 63(1); 
(d) the reports by manufacturers on tren ds referred to in Article 64; 
(e) the field safety notices by manufactur ers referred to in Article 63(5); 
(f) the information to be exchanged betw een the competent authorities of the 
Member States and between them and the Commission in accordance with Article 63(4) and (7).  
2. The information collated and processed by the electronic system shall be accessible 
to the competent authorities of the Member States, to the Commission and to the notified bodies. 
3. The Commission shall ensure that health care professionals and the public have 
appropriate levels of access to the electronic system. 
4. On the basis of arrangements between the Commission and competent authorities of 
third countries or international orga nisations, the Commission may grant those 
competent authorities or in ternational organisations access to the database at the 
appropriate level. Those ar rangements shall be based on reciprocity and make 
provision for confidentiality and data protecti on equivalent to those applicable in the 
Union.  
5. The reports on serious incidents and field sa fety corrective actions referred to in 
points (a) and (b) of Article 61(1), the period ic summary reports referred to in Article 
61(2), the reports on serious incidents referred to in the second subparagraph of 
Article 63(1) and the trend re ports referred to in Article 64 shall be automatically 
transmitted upon receipt via the electronic syst em to the competent authorities of the 
following Member States:  
(a) the Member State where the incident occurred;  
(b) the Member State where the field safety corrective action is being or is to be 
undertaken;   
EN 81   EN (c) the Member State where the manufacturer has his registered place of business;  
(d) where applicable, the Member State where the notified body, that issued a 
certificate in accordance with Article 45 for the device in question, is 
established. 
Article 63 
Analysis of serious incidents and field safety corrective actions 
1. Member States shall take the necessary steps to ensure that any information 
regarding a serious incident th at has occurred within their territory or a field safety 
corrective action that has been or is to be undertaken within their territory, and that is 
brought to their knowledge in accordance wi th Article 61 is, at national level, 
evaluated centrally by their competent au thority, if possible together with the 
manufacturer.  
If in the case of reports received in acco rdance with Article 61(3) the competent 
authority ascertains that the reports relate to  a serious incident it shall notify without 
delay those reports to the el ectronic system referred to in  Article 62, unless the same 
incident has already been reported by the manufacturer. 
2. The national competent authorities shall carr y out a risk assessment with regard to 
reported serious incidents or  field safety corrective actions, taking into account 
criteria such as causality, detectability and probability of recurrence of the problem, frequency of use of the device, probability  of occurrence of ha rm and severity of 
harm, clinical benefit of the device, intended and potential users, and population 
affected. They shall also evaluate the ade quacy of the field safety corrective action 
envisaged or undertaken by the manufacturer  and the need for and kind of any other 
corrective action. They shall monitor the manufacturer’s investigation of the incident.  
3. In the case of devices referred to in the fi rst subparagraph of Ar ticle 1(4) and where 
the serious incident or field safety corre ctive action may be re lated to a substance 
which, if used separately, would be cons idered to be a medicinal product, the 
evaluating competent authority or the coordi nating competent authority referred to in 
paragraph 6 shall inform the relevant comp etent authority for medicinal products, or 
the European Medicines Agency (EMA), that was consulted by the notified body in 
accordance with the second subpa ragraph of Article 42(2). 
In the case of devices covered by this Regulation in accordance with point (e) of 
Article 1(2) and where the serious incident  or field safety corrective action may be 
related to the tissues or cells of human or igin utilised for the manufacture of the 
device, the competent authorit y or the coordinating competen t authority referred to in 
paragraph 6 shall inform the relevant comp etent authority for human tissues and cells 
that was consulted by the notified body in accordance with the third subparagraph of Article 42(2). 
4. After carrying out the assessment, the evaluating competent authority shall, through 
the electronic system referred to in Artic le 62, inform without delay the other 
competent authorities of the corrective acti on taken or envisaged by the manufacturer  
EN 82   EN or imposed on him to minimise the risk of recurrence of a serious incident, including 
information on the underlying events a nd the outcome of its assessment. 
5. The manufacturer shall ensure that the user s of the device in question are informed 
without delay of the corrective action taken by means of a field safety notice. Except 
in case of urgency, the content of the draft field safety notice shall be submitted to the evaluating competent authority or, in cas es referred to in paragraph 6 of this 
Article, the coordinating competent author ity to allow them to make comments. 
Unless duly justified by the situation of th e individual Member St ate, the content of 
the field safety notice shall be consistent in all Member States. 
The manufacturer shall enter the field safety  notice in the electronic system referred 
to in Article 62 through which that no tice shall be accessibl e to the public.  
6. The competent authorities shall designate  a coordinating comp etent authority to 
coordinate their assessments referred to in paragraph 2 in the following cases: 
(a) where similar serious incident s related to the same devi ce or type of device of 
the same manufacturer occur in more than one Member State; 
(b) where the field safety corrective action is being or is to be undertaken in more 
than one Member State. 
Unless otherwise agreed between the co mpetent authorities, the coordinating 
competent authority shall be the one of the Member State wher e the manufacturer 
has his registered place of business.  
The coordinating competent authority sha ll inform the manufacturer, the other 
competent authorities and the Commissi on that it has assumed the role of 
coordinating authority. 
7. The coordinating competent authority sh all carry out the fo llowing tasks:  
(a) to monitor the investigation of the seri ous incident by the manufacturer and the 
corrective action to be taken;  
(b) to consult with the notified body that i ssued a certificate in accordance with 
Article 45 for the device in question re garding the impact  of the serious 
incident on the certificate; 
(c) to agree with the manufacturer and the other competent aut horities referred to 
in points (a) to (c) of Article 62(5) on the format, content and frequency of periodic summary reports in accordance with Article 61(2); 
(d) to agree with the manufacturer and othe r competent authorit ies concerned on 
the implementation of the appropriate  field safety corrective action; 
(e) to inform the other competent author ities and the Commission, through the 
electronic system referred to in Article  62, of the progress in and the outcome 
of its assessment.  
EN 83   EN The designation of a coordinating competent authority shall not affect the rights of 
the other competent authorities to perf orm their own assessment and to adopt 
measures in accordance with this Regulatio n in order to ensure the protection of 
public health and patient safety. The c oordinating competent authority and the 
Commission shall be kept informed of th e outcome of any such assessment and the 
adoption of any such measures.  
8. The Commission shall provide secretarial support to the coordinating competent 
authority in the accomplishment of  its tasks under this Chapter. 
Article 64 
Trend reporting 
Manufacturers of devices classified in class II b and III shall report to the electronic system 
referred to in Article 62 any stat istically significant increase in the frequency or severity of 
incidents that are not serious incidents or of expected undesirable side-effects that have a significant impact on the risk-benefit analysis re ferred to in Sections 1 and 5 of Annex I and 
which have led or may lead to una cceptable risks to the health or  safety of patients, users or 
other persons when weighted against the intended  benefits. The significa nt increase shall be 
established in comparison to the foreseeable fr equency or severity of such incidents or 
expected undesirable side-effects in respect of the device, or category or group of devices, in 
question during a specific time period as es tablished in the manufacturer’s conformity 
assessment. Article 63 shall apply. 
Article 65 
Documentation of vigilance data 
Manufacturers shall update their technical documentation with information on incidents 
received from healthcare professionals, patients  and users, serious incidents, field safety 
corrective actions, periodic summary reports refe rred to in Article 61, tr end reports referred to 
in Article 64 and field safety notices referred to in Article 63(5). They shall make this documentation available to their notified bodi es, which shall assess the impact of the 
vigilance data on the conformity as sessment and the certificate issued. 
Article 66 
Implementing acts 
The Commission may, by means of implementing acts, adopt the modalities and procedural 
aspects necessary for the implementation of Articles 61 to 65 as re gards the following:  
(a) typology of serious incidents and field sa fety corrective acti ons in relation to 
specific devices, or categories  or groups of devices; 
(b) harmonised forms for the reporting of serious incidents and field safety 
corrective actions, periodic summar y reports and trend reports by 
manufacturers as referred to  in Articles 61 and 64;  
(c) timelines for the reporting of serious incidents and field safety corrective 
actions, periodic summary reports and trend reports by manufacturers, taking  
EN 84   EN into account the severity of the event to be reported as referred to in Articles 61 
and 64; 
(d) harmonised forms for the exchange of information between competent 
authorities as referre d to in Article 63. 
Those implementing acts shall be adopted in  accordance with the examination procedure 
referred to in Article 88(3). 
SECTION 2 – MARKET SURVEILLANCE  
Article 67 
Market surveillance activities 
1. The competent authorities shall perform a ppropriate checks on the characteristics and 
performance of devices including, where a ppropriate, review of documentation and 
physical or laboratory checks on the basis of  adequate samples. They shall take 
account of established principles regardin g risk assessment and risk management, 
vigilance data and complaints. The comp etent authorities may require economic 
operators to make available the documentation and information necessary for the purpose of carrying out their activities and, where necessary and justified, enter the 
premises of economic operators and take the necessary samples of devices. They may destroy or otherwise render inoperable  devices presenting a serious risk where 
they deem it necessary. 
2. The Member States shall periodically re view and assess the functioning of their 
surveillance activities. Such reviews and a ssessments shall be carried out at least 
every four years and the results thereof shall be communicated to the other Member States and the Commission. The Member St ate concerned shall make a summary of 
the results accessi ble to the public. 
3. The competent authorities of the Member States shall coordinate their market 
surveillance activities, cooperate with each other and share with each other and with 
the Commission the results thereof. Where appropriate, the competent authorities of the Member States shall agree on work-sharing a nd specialisation. 
4. Where more than one authority in a Me mber State is responsible for market 
surveillance and external border controls, t hose authorities shall cooperate with each 
other, by sharing information releva nt to their role  and functions.  
5. The competent authorities of the Member St ates shall cooperate with the competent 
authorities of third countries with a view  to exchanging inform ation and technical 
support and promoting activities re lating to market surveillance. 
Article 68 
Electronic system on market surveillance 
1. The Commission, in collaboration with the Member States, shall set up and manage 
an electronic system to collate and process the following information:  
EN 85   EN (a) information in relation to non-compliant de vices presenting a ri sk to health and 
safety referred to in Article 70(2), (4) and (6); 
(b) information in relation to compliant devices presenting a risk to health and 
safety referred to in Article 72(2); 
(c) information in relation to formal non-compliance of products referred to in 
Article 73(2); 
(d) information in relation to preventive hea lth protection measures referred to in 
Article 74(2). 
2. The information mentioned in paragraph 1 shall be immediately transmitted through 
the electronic system to all competent aut horities concerned and be accessible to the 
Member States and to the Commission. 
Article 69 
Evaluation regarding devices presenting a risk  to health and safety at national level 
Where the competent authorities of a Member  State, based on vigi lance data or other 
information, have sufficient reason to believe that  a device presents a ri sk to the health or 
safety of patients, users or ot her persons, they shall carry out an evaluation in relation to the 
device concerned covering all th e requirements laid down in this  Regulation that  are relevant 
to the risk presented by the device. The rele vant economic operators shall cooperate as 
necessary with the co mpetent authorities. 
Article 70 
Procedure for dealing with non-compliant devi ces presenting a risk to health and safety 
1. Where, having performed an evaluation pursuant to Article 69, the competent 
authorities find that the device, which presen ts a risk to the health or safety of 
patients, users or other pers ons, does not comply with the requirements laid down in 
this Regulation, they shall without delay requir e the relevant economic operator to 
take all appropriate and duly justified co rrective action to bring the device into 
compliance with those requirements, to prohi bit or restrict the making available of 
the device on the market, to subject the maki ng available of the device to specific 
requirements, to withdraw the device from  the market, or to recall it within a 
reasonable period, proportionate to  the nature of the risk.  
2. Where the competent authorities consider that non-compliance is not restricted to 
their national territory, they shall info rm the Commission and the other Member 
States of the results of the evaluation and of the actions which they have required the 
economic operators to take, by means of the electronic system referred to in Article 
68. 
3. The economic operators shall en sure that all appr opriate corrective act ion is taken in 
respect of all the devices c oncerned that they have made  available on the market 
throughout the Union.   
EN 86   EN 4. Where the relevant economic operator doe s not take adequate corrective action 
within the period referred to in paragraph 1, the competent authorities shall take all 
appropriate provisional measures to prohibi t or restrict the device’s being made 
available on their national market, to wit hdraw the device from that market or to 
recall it. 
They shall notify the Commission and the other Member States , without delay, of 
those measures, by means of the electroni c system referred to in Article 68.  
5. The notification referred to in paragraph 4 shall include  all available details, in 
particular the data necessary for the iden tification of the non-co mpliant device, the 
origin of the device, the na ture of and the reasons for the non-compliance alleged and 
the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.  
6. Member States other than the Member St ate initiating the pro cedure shall without 
delay inform the Commission and the ot her Member States of any additional 
information at their disposal relating to the non-compliance of the device concerned 
and of any measures adopted by them in relation to the device concerned. In the 
event of disagreement with the notified na tional measure, they shall without delay 
inform the Commission and the other Member States of their obje ctions, by means of 
the electronic system re ferred to in Article 68. 
7. Where, within two months of receipt of the notification refe rred to in paragraph 4, no 
objection has been raised by either a Member  State or the Commission in respect of a 
provisional measure taken by a Member St ate, that measure shall be deemed 
justified.  
8. All Member States shall ensure that a ppropriate restrictive measures are taken 
without delay in respect of  the device concerned. 
Article 71 
Procedure at Union level 
1. Where, within two months of receipt of th e notification referred to in Article 70(4), 
objections are raised by a Member Stat e against a provisional measure taken by 
another Member State, or where the Co mmission considers the measure to be 
contrary to Union legislation, the Commissi on shall evaluate the national measure. 
On the basis of the results of that eval uation, the Commission shall decide, by means 
of implementing acts, whether or not th e national measure is justified. Those 
implementing acts shall be adopted in acc ordance with the ex amination procedure 
referred to in Article 88(3). 
2. If the national measure is considered justified, Article 70(8) shall apply. If the 
national measure is considered unjustified, the Member State concerned shall withdraw the measure. Where, in the situ ations referred to in  Articles 70 and 72, a 
Member State or the Commission consider that the risk to health and safety 
emanating from a device cannot be contai ned satisfactorily by means of measures 
taken by the Member State(s) concerned, the Commission, at the request of a 
Member State or on its own initiative, may take, by means of implementing acts, the  
EN 87   EN necessary and duly justified measures to en sure the protection of  health and safety, 
including measures restrict ing or prohibiting the placi ng on the market and putting 
into service of the device concerned. Thos e implementing acts shall be adopted in 
accordance with the examination proce dure referred to in Article 88(3). 
3. On duly justified imperative grounds of urgenc y relating to the heal th and safety of 
humans, the Commission shall adopt imme diately applicable implementing acts 
referred to in paragraphs 1 and 2 in accord ance with the procedure referred to in 
Article 88(4). 
Article 72 
Procedure for dealing with compliant devices presenting a risk to health and safety 
1. Where, having performed an evaluation pursu ant to Article 69, a Member State finds 
that although a device has been legally pla ced on the market or put into service, it 
presents a risk to the health or safety of patients, users or other persons or to other 
aspects of the protection of public hea lth, it shall require the relevant economic 
operator or operators to take all appropriate  provisional measures to ensure that the 
device concerned, when placed on the market or put into service, no longer presents 
that risk, to withdraw the device from the market or to recall it within a reasonable 
period, proportionate to the nature of the risk. 
2. The Member State shall immediately notif y the Commission and the other Member 
States of the measures taken, by means of th e electronic system referred to in Article 
68. That information shall include the data  necessary for the id entification of the 
device concerned, the origin and the supply chain of the device, the findings of the 
Member State's evaluation specifying the natu re of the risk involved and the nature 
and duration of the national measures taken.  
3. The Commission shall evaluate the provisional national meas ures taken. On the basis 
of the results of that evaluation, th e Commission shall decide, by means of 
implementing acts, whether or not the meas ure is justified. Those implementing acts 
shall be adopted in accordance with the exam ination procedure referred to in Article 
88(3). On duly justified imperative grounds of urgency relating to the he alth and 
safety of humans, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 88(4). 
4. Where the national measure is considered justified, Article 70(8) shall apply. If the 
national measure is considered unjustified, the Member State concerned shall withdraw the measure.  
Article 73 
Formal non-compliance 
1. Without prejudice to Article 70, a Member State shall require the relevant economic 
operator to put an end to the non-compliance concerned within a reasonable period that is proportionate to the non-complia nce where it makes one of the following 
findings:  
EN 88   EN (a) that the CE marking has been affixed in  violation of the formal requirements 
laid down in Article 18; 
(b) that the CE marking has not been affixe d to a device contrary to Article 18; 
(c) that the CE marking has been inappr opriately affixed in accordance with 
procedures in this Regulation on a pr oduct that is not covered by this 
Regulation;  
(d) that the EU declaration of conform ity has not been drawn up or is not 
complete; 
(e) that the information to be supplied by the manufacturer on the label or in the 
instructions for use is not available,  not complete or not provided in the 
language(s) required;  
(f) that the technical documentation, incl uding the clinical evaluation, is not 
available or not complete. 
2. Where the economic operator does not put an  end to the non-compliance within the 
period referred to in paragraph 1, the Member State concerned shall take all 
appropriate measures to rest rict or prohibit the product being made available on the 
market or to ensure that it is recalled or withdrawn from the market. That Member 
State shall inform the Commission and the other Member States without delay of 
those measures, by means of the electroni c system referred to in Article 68. 
Article 74 
Preventive health protection measures 
1. Where a Member State, after having perf ormed an evaluation which indicates a 
potential risk related to a de vice or a specific category or group of devices considers 
that the making available on the market or putting into service of such device or 
specific category or group of devices should be prohibited, restricted or made subject 
to particular requirements or that such device or category or group of devices should 
be withdrawn from the market or recalled in order to protect the he alth and safety of 
patients, users or other pers ons or other aspects of public  health, it may take any 
necessary and justifie d provisional measures. 
2. The Member State shall immediately notif y the Commission and all other Member 
States, giving the reasons for its decision, by means of the electronic system referred 
to in Article 68.  
3. The Commission shall assess the prov isional national measures taken. The 
Commission shall decide, by means of im plementing acts, whether the national 
measures are justified or not. Those implementing acts shall be adopted in 
accordance with the examination proce dure referred to in Article 88(3).  
On duly justified imperative grounds of urgenc y relating to the heal th and safety of 
humans, the Commission may adopt immediat ely applicable implementing acts in 
accordance with the procedure referred to in Article 88(4).  
EN 89   EN 4. Where the assessment referred to in para graph 3 demonstrates that the making 
available on the market or putting into se rvice of a device, sp ecific category or group 
of devices should be prohibited, restricted or made subject to particular requirements 
or that such device or ca tegory or group of devices s hould be withdrawn from the 
market or recalled in all Member States in order to protect the he alth and safety of 
patients, users or other persons or other aspects of public hea lth, the Commission 
shall be empowered to adopt de legated acts in accordance wi th Article 89 to take the 
necessary and duly justified measures. 
Where in this case imperative grounds of ur gency so require, the procedure provided 
for in Article 90 shall apply to delegated acts adopted pursuant to this paragraph. 
Article 75 
Good administrative practice 
1. Any measure adopted by the competent author ities of the Member States pursuant to 
Articles 70 to 74 shall stat e the exact grounds on which it is based. Where it is 
addressed to a specific economic operator, it shall be notified without delay to the 
economic operator concerned, who shall at the same time be informed of the 
remedies available to him under the law of  the Member State concerned and of the 
time limits to which such remedies are subject. Where the measure is of general 
scope, it shall be appropriately published.  
2. Except in cases where immediate action is n ecessary for reasons of serious risk to 
human health or safety, the economic operator concerned shall be given the 
opportunity to make submissions to the co mpetent authority within an appropriate 
period of time before any measure is a dopted. If action has been  taken without the 
economic operator’s being heard, he shal l be given the opportunity to make 
submissions as soon as possible and the ac tion taken shall be reviewed promptly 
thereafter. 
3. Any measure adopted shall be immedi ately withdrawn or amended upon the 
economic operator’s demonstrating that he  has taken effective corrective action. 
4. Where a measure adopted pursuant to Article s 70 to 74 concerns a product for which 
a notified body has been involved in the conformity assessment, the competent authorities shall inform the relevant  notified body of the measure taken.  
Chapter VIII 
Cooperation between Member States, Medical Device 
Coordination Group, EU reference  laboratories, device registers 
Article 76 
Competent authorities  
1. The Member States shall designate the comp etent authority or au thorities responsible 
for the implementation of this Regulation. Th ey shall entrust thei r authorities with 
the powers, resources, equipment and knowledge necessary for the proper  
EN 90   EN performance of their tasks pursuant to this Regulation. The Member States shall 
communicate the competent authorities to the Commission which shall publish a list of competent authorities.  
2. For the implementation of Articles 50 to 60, the Member States may designate a 
national contact point other than a national authority. In this case, references to a 
competent authority in this Regulation sh all be understood as including the national 
contact point. 
Article 77 
Cooperation  
1. The competent authorities of the Member St ates shall cooperate with each other and 
with the Commission and exchange with e ach other the information necessary to 
enable this Regulation to  be applied uniformly. 
2. Member States and the Commission shall pa rticipate in initiatives developed at 
international level with the aim of ensuring cooperation between regulatory 
authorities in the field of medical devices. 
Article 78 
Medical Device Coordination Group 
1. A Medical Device Coordi nation Group (MDCG) is hereby established.  
2. Each Member State shall appoint, for a th ree-year term which may be renewed, one 
member and one alternate providing expertise in the field of this Regulation, and one 
member and one alternate providing expert ise in the field of Regulation (EU) No 
[…/…] [on in vitro  diagnostic medical devices]. A Member State may choose to 
appoint only one member and one altern ate providing expertise in both fields.  
The members of the MDCG shall be chosen  for their competence and experience in 
the field of medical devices and in vitro  diagnostic medical devices. They shall 
represent the competent authorities of th e Member States. The names and affiliation 
of members shall be made  public by the Commission. 
The alternates shall represent and vote for the members in their absence.  
3. The MDCG shall meet at regular interval s and, where the situation requires, on a 
request from the Commission or a Member State. The meetings shall be attended 
either by the members appointed for their ro le and expertise in the field of this 
Regulation, or by the members appointed for their expertise in the field of Regulation 
(EU) No […/…] [on in vitro  diagnostic medical devices], or by the members 
appointed for both Regula tions, as appropriate.  
4. The MDCG shall use its best endeavours to  reach consensus. If such consensus 
cannot be reached, the MDCG shall decide by the major ity of its members. Members 
with diverging positions may request that their positions and the grounds on which they are based are recorded in the MDCG's position.  
EN 91   EN 5. The MDCG shall be chaired by a represen tative of the Commission. The chair shall 
not take part in votes of the MDCG.  
6. The MDCG may invite, on a case-by-case basi s, experts and other third parties to 
attend meetings or provide written contributions. 
7. The MDCG may establish standing or te mporary sub-groups. Where appropriate, 
organisations representing the interests of  the medical device industry, healthcare 
professionals, laboratories, patients and cons umers at Union level shall be invited in 
such sub-groups in the capacity of observers.  
8. The MDCG shall establish its rules of pro cedure which shall, in particular, lay down 
procedures for the following: 
– the adoption of opinions or recommenda tions or other positions by the MDCG, 
including in cases of urgency;  
– the delegation of tasks to reporting and co-reporting members; 
– the functioning of sub-groups.  
The rules of procedure shall enter into force after receiving a favourable opinion 
from the Commission. 
Article 79 
Support by the Commission 
The Commission shall support the functioning of  the cooperation between national competent 
authorities and provide technica l, scientific and logistic s upport to the MDCG and its sub-
groups. It shall organise  the meetings of the MDCG and it s sub-groups, participate in those 
meetings and ensure the appropriate follow-up. 
Article 80 
Tasks of the MDCG 
The MDCG shall have the following tasks: 
(a) to contribute to the asse ssment of applicant conformity assessment bodies and 
notified bodies pursuant to the pr ovisions set out in Chapter IV; 
(b) to contribute to the scrutiny of certain  conformity assessments pursuant to 
Article 44; 
(c) to contribute to the development of guidance aimed at ensuring effective and 
harmonised implementation of this Regul ation, in particular regarding the 
designation and monitoring of notified bodies , application of the general safety 
and performance requirements and conduct of the clinical evaluation by manufacturers and the asse ssment by notified bodies;  
EN 92   EN (d) to assist the competent authorities of the Member States in their coordination 
activities in the fields of clinical investigations, vigilance and market 
surveillance; 
(e) to provide advice and assist the Commissi on, at its request, in its assessment of 
any issue related to the impleme ntation of this Regulation; 
(f) to contribute to harmonised administrative practice with regard to medical 
devices in the Member States. 
Article 81 
European Union reference laboratories 
1. For specific devices, or a cate gory or group of devices, or for specific hazards related 
to a category or group of devices, the Commission may designate, by means of 
implementing acts, one or more European Union reference laboratories, hereinafter 
referred to as 'EU reference laboratories', that  satisfy the criteria set out in paragraph 
3. The Commission shall only designate labo ratories for which a Member State or 
the Commission's Joint Research Centre have submitted an application for designation. 
2. Within the scope of their designation, the EU reference laboratories shall, where 
appropriate, have the following tasks: 
(a) to provide scientific and technical a ssistance to the Commission, the Member 
States and notified bodies in relation to the implementation of this Regulation; 
(b) to provide scientific advice regarding the state of the art in relation to specific 
devices, or a category or group of devices; 
(c) to set up and manage a network of nati onal reference labora tories and publish a 
list of the participating national refere nce laboratories and their respective 
tasks; 
(d) to contribute to the development of appr opriate testing and an alysis methods to 
be applied for conformity assessment procedures and market surveillance; 
(e) to collaborate with notifie d bodies in the development of best practices for the 
performance of conformity assessment procedures; 
(f) to contribute to the development of  standards at international level; 
(g) to provide scientific opinions in respons e to consultations by notified bodies in 
accordance with this Regulation. 
3. EU reference laboratories shall satisfy the following criteria: 
(a) to have appropriately qualified staff w ith adequate knowledge and experience 
in the field of the medical device s for which they are designated;  
EN 93   EN (b) to possess the necessary equipment and refe rence material to carry out the tasks 
assigned to them; 
(c) to have the necessary know ledge of international stan dards and best practices; 
(d) to have an appropriate administ rative organisation and structure; 
(e) to ensure that their staff observe the c onfidentiality of the information and data 
obtained in carrying out their tasks. 
4. EU reference laboratories may be gran ted a Union financ ial contribution. 
The Commission may adopt, by means of implementing acts, the modalities and the 
amount of the grant of a Union financial c ontribution to EU reference laboratories, 
taking into account the objectiv es of protection of health and safety, support of 
innovation and cost-effectiven ess. Those implementing act s shall be adopted in 
accordance with the examination proce dure referred to in Article 88(3). 
5. Where notified bodies or Member States request  scientific or technical assistance or 
a scientific opinion from an EU reference laboratory, they may be required to pay 
fees to wholly or partially cover the cost s incurred by that labor atory in carrying out 
the requested task according to a set of predetermined and transparent terms and 
conditions.  
6. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 89 for the following purposes: 
(a) amending or supplementing the tasks of EU  reference laboratories referred to 
in paragraph 2 and the criteria to be satisfied by EU reference laboratories 
referred to in paragraph 3.  
(b) setting out the structure and the level of  the fees referred to in paragraph 5 
which may be levied by an EU Refere nce Laboratory for providing scientific 
opinions in response to cons ultations by notified bodies in  accordance with this 
Regulation, taking into account the objec tives of protection of human health 
and safety, support of innovati on and cost-effectiveness.  
7. EU reference laboratories shall be subject to controls, including on-site visits and 
audits, by the Commission to verify compliance with the requirements of this Regulation. If these controls find that a laboratory is not complying with those 
requirements for which they have been designated, the Commission, by means of 
implementing acts, shall take appropriate m easures, including the withdrawal of the 
designation. 
Article 82 
Conflict of interests 
1. Members of the MDCG and staff of the EU  reference laboratories shall not have 
financial or other interests in the medical device industr y which could affect their 
impartiality. They shall undertak e to act in the p ublic interest and in an independent 
manner. They shall declare any direct and indirect interests they may have in the  
EN 94   EN medical device industry and update this de claration whenever a relevant change 
occurs. Upon request, the declaration of in terests shall be acces sible to the public. 
This Article shall not apply to the repr esentatives of stakeholder organisations 
participating in the sub-groups of the MDCG. 
2. Experts and other third part ies invited by the MDCG on a case-by-case basis shall be 
requested to declare their inte rests in the issue in question. 
Article 83 
Device registers 
The Commission and the Member States shall take  all appropriate measures to encourage the 
establishment of registers for specific types of devices to gather post-market experience related to the use of such devices. Such re gisters shall contribute to the independent 
evaluation of the long-term safety  and performance of devices. 
Chapter IX 
Confidentiality, data prot ection, funding, penalties  
Article 84 
Confidentiality 
1. Unless otherwise provided in this Regula tion and without prejudice to existing 
national provisions and practices in the Memb er States on medica l confidentiality, all 
parties involved in the application of this  Regulation shall resp ect the confidentiality 
of information and data obtained in carryi ng out their tasks in order to protect the 
following:  
(a) personal data in compliance with Direct ive 95/46/EC and Re gulation (EC) No 
45/2001;  
(b) commercial interests of a natural or  legal person, incl uding intellectual 
property rights;  
(c) the effective implementation of this Regul ation, in particular for the purpose of 
inspections, investigat ions or audits.  
2. Without prejudice to paragraph 1, info rmation exchanged between competent 
authorities and between competent author ities and the Commission on condition of 
confidentiality shall remain confidential unl ess the originating au thority has agreed 
to its disclosure.  
3. Paragraphs 1 and 2 shall no t affect the rights and oblig ations of the Commission, 
Member States and notified bodies with rega rd to exchange of information and the 
dissemination of warnings, nor the obligati ons of the persons concerned to provide 
information under criminal law.   
EN 95   EN 4. The Commission and Member States may ex change confidential information with 
regulatory authorities of third countries with  which they have c oncluded bilateral or 
multilateral confidentiality arrangements. 
Article 85 
Data protection 
1. Member States shall apply Directive 95/46/ EC to the processing of personal data 
carried out in the Member Stat es pursuant to this Regulation. 
2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried 
out by the Commission pursuant to this Regulation. 
Article 86 
Levy of fees 
This Regulation shall be without prejudice to the possibility fo r Member States to levy fees 
for the activities set out in this Regulation, provi ded that the level of the fees is set in a 
transparent manner and on the basis of cost r ecovery principles. They shall inform the 
Commission and the other Member States at least three months before the structure and level 
of fees is to be adopted. 
Article 87 
Penalties 
The Member States shall lay down the provisions on penalties applicable for infringement of 
the provisions of this Regulation and shall take all measures necessary to ensure that they are 
implemented. The penalties provided for must be  effective, proportionate, and dissuasive. The 
Member States shall notify thos e provisions to the Commission by [3 months prior to the date 
of application of the Regulation] and shal l notify it without delay of any subsequent 
amendment affecting them. 
Chapter X 
Final provisions 
Article 88 
Committee procedure 
1. The Commission shall be assisted by a Committee on Medical Devices. That 
Committee shall be a committee within the meaning of Regulation (EU) No 
182/2011. 
2. Where reference is made to this paragr aph, Article 4 of Regulation (EU) No 
182/2011 shall apply. 
3. Where reference is made to this paragr aph, Article 5 of Regulation (EU) No 
182/2011 shall apply.  
EN 96   EN 4. Where reference is made to this paragr aph, Article 8 of Regulation (EU) No 
182/2011, in conjunction with Article 4 or Article 5, as approp riate, shall apply. 
Article 89 
Exercise of the delegation 
1. The power to adopt the delegated acts referred  to in Articles 2(2) and (3), 4(5), 8(2), 
17(4), 24(7), 25(7), 29(2), 40(2), 41(4), 42( 11), 45(5), 51(7), 53(3), 74(4) and 81(6) 
is conferred on the Commission subject to th e conditions laid down in this Article.  
2. The delegation of power referred to in Artic les 2(2) and (3), 4( 5), 8(2), 17(4), 24(7), 
25(7), 29(2), 40(2), 41(4), 42( 11), 45(5), 51(7), 53(3), 74( 4) and 81(6) shall be 
conferred on the Commission for an indeterm inate period of time from the date of 
entry into force of this Regulation. 
3. The delegation of power referred to in Artic les 2(2) and (3), 4( 5), 8(2), 17(4), 24(7), 
25(7), 29(2), 40(2), 41(4), 42(11), 45(5), 51(7), 53(3), 74(4) and 81(6) may be 
revoked at any time by the European Par liament or by the Council. A decision of 
revocation shall put an end to the delegation of the power specified in that decision. 
It shall take effect the day following its publication in the Official Journal of the 
European Union or at a later date specified therein. It shall not affect the validity of 
any delegated acts already in force. 
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council.  
5. A delegated act adopted pursuant to any of  the Articles listed in  paragraph 1 shall 
enter into force only if no objection has been expressed either by the European 
Parliament or by the Council within a period of two months of notif ication of that act 
to the European Parliament and the Council or  if, before the expiry  of that period, the 
European Parliament and the Council have both informed the Commission that they 
will not object. That period may be extended by two months at the initiative of the 
European Parliament or the Council. 
Article 90 
Urgency procedure for delegated acts 
1. Delegated acts adopted under this Article shall enter into force without delay and 
shall apply as long as no objection is expr essed in accordance with paragraph 2. The 
notification of a delegated ac t to the European Parliame nt and to the Council shall 
state the reasons for the use of the urgency procedure. 
2. Either the European Parliament or the Council may object to a delegated act in 
accordance with the procedure referred to in Article 89. In such a case, the 
Commission shall repeal th e act without delay followi ng the notification of the 
decision to object by the European  Parliament or the Council.   
EN 97   EN Article 91 
Amendments to Directive 2001/83/EC 
In Annex I of Directive 2001/83/EC, point 12 of  Section 3.2. is replaced by the following:  
‘(12) Where a product is governed by this Directive in accordance with the second 
subparagraph of Article 1(4) or  the second subparagraph of Artic le 1(5) of Regulation (EU) 
[…/…] on medical devices55, the marketing authorisation dossier shall include, where 
available, the results of the assessment of the c onformity of the device part with the relevant 
general safety and performance requirements of Annex I of that Regulation contained in the 
manufacturer’s EU declaration of  conformity or the relevant certificate issued  by a notified 
body allowing the manufacturer to affix a CE marking to the medical device.  
If the dossier does not include th e results of the conformity assessment referred to in the first 
subparagraph and where for the conformity assessm ent of the device, if used separately, the 
involvement of a notified body is required in accordance with Regulation (EU) […/…], the 
authority shall require the applican t to provide an opinion on the conformity of the device part 
with the relevant general safety and performa nce requirements of Anne x I of that Regulation 
issued by a notified body designated in accordance w ith that Regulation for the type of device 
in question, unless the authority is advised by its  experts for medical devices that involvement 
of a notified body is not required.’ 
Article 92 
Amendments to Regulation (EC) No 178/2002 
In the third subparagraph of Article 2 of Re gulation (EC) No 178/2002, the following point (i) 
is added:  
‘(i) medical devices within the m eaning of Regulation (EU) […/…]56.’ 
Article 93 
Amendments to Regulation (EC) No 1223/2009 
In Article 2 of Regulation (EC) No 1223/ 2009, the following paragraph is added:  
‘4. In accordance with the regulatory procedure referred to in Article 32(2), the Commission 
may, at the request of a Member State or on its own initiative, adopt the necessary measures 
to determine whether or not a specific product or  group of products falls within the definition 
‘cosmetic product’.’  
                                                 
55 OJ L […], […], p. […]. 
56 OJ L […], […], p. […].  
EN 98   EN Article 94 
Transitional provisions  
1. From the date of applicati on of this Regulation any publi cation of a notification in 
respect of a notified body in accordance w ith Directives 90/385/EEC and 93/42/EEC 
shall become void.  
2. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 
93/42/EEC prior to the entry into force of th is Regulation shall remain valid until the 
end of the period indicated on the certificate, except fo r certificates issued in 
accordance with Annex 4 of Directive 90 /385/EEC or Annex IV of Directive 
93/42/EEC which shall become void at the latest two years after the date of 
application of this Regulation.  
Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 
93/42/EEC after the entry into force of this Regulation shall become void at the latest 
two years after the date of a pplication of this Regulation.  
3. By way of derogation from Directives  90/385/EEC and 93/42/EEC, devices which 
comply with this Regulation may be placed on the market before its date of application.  
4. By way of derogation from Directives  90/385/EEC and 93/42/EEC, conformity 
assessment bodies which comply with this Regulation may be designated and notified before its date of applicati on. Notified bodies which are designated and 
notified in accordance with this Regulation may apply the conformity assessment 
procedures laid down in this Regulation and issue certificates  in accordance with this 
Regulation before its date of application. 
5. By way of derogation from Article 10a and point (a) of Article 10b(1) of Directive 
90/385/EEC and Article 14(1) and (2) and po ints (a) and (b) of  Article 14a(1) of 
Directive 93/42/EEC, manufacturers, aut horised representatives, importers and 
notified bodies who, during the period from [date of applicati on] until [18 months 
after date of application], comply with Article 25(2) and (3) and Article 45(4) of this Regulation shall be considered to comply with the laws and regulations adopted by 
Member States in accordance with, re spectively, Article 10a of Directive 
90/385/EEC or Article 14(1) a nd (2) of Directive 93/42/ EEC and with, respectively, 
point (a) of Article 10b(1) of Directive 90/385/EEC or points (a) and (b) of Article 
14a(1) of Directive 93/42/EEC as speci fied in Commission Decision 2010/227/EU. 
6. Authorisations granted by competent author ities of the Member States in accordance 
with Article 9(9) of Dir ective 90/385/EEC or Article 11(13) of Directive 93/42/EEC 
shall keep the valid ity indicated in th e authorisation.  
7. Devices falling within the scope of this Re gulation in accordance with point (e) of 
Article 1(2) which have been legally placed  on the market or put into service in 
accordance with the rules in force in the Me mber States prior to the application of 
this Regulation may continue to be placed on the market and put into service in the 
Member States concerned.   
EN 99   EN 8. Clinical investigations which have started to be conducted in accordance with Article 
10 of Directive 90/385/EEC or Article 15 of Directive 93/42/EEC prior to the 
application of this Regulation may continue to be conducted. As of the application of 
this Regulation, however, the reporting of  serious adverse events and device 
deficiencies shall be ca rried out in accordance with this Regulation.  
Article 95 
Evaluation 
No later than seven years after the date of  application, the Commission shall assess the 
application of this Regulation and establish an evaluation report on the progress towards 
achievement of the objectives of the Regulation including an assessment of resources required 
to implement this Regulation.  
Article 96 
Repeal 
Council Directives 90/385/EEC and 93/42/EEC are repealed with effect from [date of 
application of this Regulation] , with the exception of Article 10a and point (a) of Article 
10b(1) of Directive 90/385/EEC and Article 14(1) and (2) and points (a) and (b) of Article 
14a(1) of Directive 93/42/EEC whic h are repealed with effect fr om [18 months after date of 
application]. 
References to the repealed C ouncil Directives shall be unde rstood as reference to this 
Regulation and shall be read in accordance wi th the correlation table laid down in Annex 
XVI. 
Article 97 
Entry into force and date of application 
1. This Regulation shall enter into force on th e twentieth day after its publication in the 
Official Journal of the European Union . 
2. It shall apply from [three y ears after entry into force]. 
3. By way of derogation from paragr aph 2 the following shall apply: 
(a) Article 25(2) and (3) and Article 45(4) sh all apply from [18 months after date 
of application referred to in paragraph 2]; 
(b) Articles 28 to 40 and Articl e 78 shall apply from [six months after entry into 
force]. However, prior to [date of applic ation as referred to in paragraph 2], the 
obligations on notified bodies emanating fr om the provisions in Articles 28 to 
40 shall apply only to those bodies which submit an application for notification 
in accordance with Article 31 of this Regulation.  
This Regulation shall be binding in  its entirety and directly applicable in all Member States.  
EN 100   EN Done at Brussels, 26.9.2012 
For the European Parliament For the Council 
The President The President  
EN 101   EN ANNEX I 
GENERAL  SAFETY  AND  PERFORMANCE  REQUIREMENTS 
I. General requirements  
1. Devices shall achieve the pe rformance intended by the ma nufacturer and be designed 
and manufactured in such a way that, duri ng normal conditions of use, they are 
suitable for their intended purpose, taking into account the generally acknowledged 
state of the art. They shall not compromise  the clinical condition or the safety of 
patients, or the safety and health of users or, where applicable, other persons, 
provided that any risks which may be associat ed with their use constitute acceptable 
risks when weighed against the benefits to the patient and are compatible with a high 
level of protection of health and safety. 
This shall include:  – reducing as far as possible the risk of us e error due to  ergonomic features of the 
device and the environment in which the de vice is intended to be used (design 
for patient safety), and  
– consideration of the technical knowledge , experience, education and training, 
and the medical and physical conditions  of intended users (design for lay, 
professional, disabled or other users).  
2. The solutions adopted by the manufacturer for the design and manufacture of the 
devices shall conform to safety princi ples, taking account of the generally 
acknowledged state of the art. To reduce risks, the manufacture r shall manage the 
risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. The manufacturer shall apply the following 
principles in the pr iority order listed: 
(a) identify known or foreseeable hazards and estimate the associated risks arising 
from the intended use and foreseeable misuse; 
(b) eliminate risks as far as possible through inherently safe design and 
manufacture; 
(c) reduce as far as possible the remaini ng risks by taking adequate protection 
measures, including alarms; and 
(d) provide training to user s and/or inform users of any residual risks. 
3. The characteristics and performances of the device shall not be adversely affected to 
such a degree that the health or safety  of the patient or the user and, where 
applicable, of other persons are compromi sed during the lifetime of the device, as 
indicated by the manufacturer,  when the device is subjected to the stresses which can 
occur during normal conditions of use a nd has been properly maintained in 
accordance with the manufacturer’s instructions . When no lifetime is stated, the same  
EN 102   EN applies for the lifetime reasonably to be expected of a device of that kind, having 
regard to the intended purpose and th e anticipated use of the device.  
4. Devices shall be designed, manufactured and packaged in such a way that their 
characteristics and performances during th eir intended use will  not be adversely 
affected by transport and storage conditions (f or example, fluctuations of temperature 
and humidity) taking account of the instru ctions and information provided by the 
manufacturer. 
5. All known and foreseeable risks, and an y undesirable side-effects, shall be 
minimised and be acceptable when weighed ag ainst the benefits to the patient of the 
achieved performance of the device during normal conditions of use. 
6. For devices listed in Annex XV for which the manufacturer does not claim a medical 
purpose, the general requirements set out in Sections 1 and 5 shall be understood that 
the device, when used under the conditions and for the purposes intended, shall not 
present any risk or only the minimum accep table risks related to the product’s use 
which is consistent with a high level of protection for the safety and health of persons. 
II. Requirements regarding design and construction  
7. Chemical, physical and biological properties 
7.1. The devices shall be designe d and manufactured in such  a way as to ensure the 
characteristics and performance referred to  in Chapter I ‘General Requirements’. 
Particular attention shall be paid to: 
(a) the choice of materials used, particul arly as regards toxicity and, where 
appropriate, flammability; 
(b) the compatibility between the materials used and biological tissues, cells, and 
body fluids taking account of the intended purpose of the device; 
(c) where appropriate, the results of bi ophysical or modelli ng research whose 
validity has been demonstrated beforehand;  
(d) the choice of materials used, reflecti ng, where appropriate, matters such as 
hardness, wear and fatigue strength. 
7.2. The devices shall be designed, manufactured  and packaged in such a way as to 
minimise the risk posed by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons involved in the transport, 
storage and use of the devices. Particular a ttention shall be paid to tissues exposed 
and to the duration and frequency of exposure. 
7.3. The devices shall be designed and manufactured  in such a way that they can be used 
safely with the materials and substances, including gases, with which they enter into contact during their normal use or during routine procedures; if the devices are 
intended to administer medicinal products they shall be designe d and manufactured 
in such a way as to be compatible with  the medicinal products concerned according 
to the provisions and restri ctions governing these medi cinal products and that both  
EN 103   EN the performance of the medicinal products and of the devices are maintained in 
accordance with their respective indications and intended use. 
7.4. The devices shall be designed and manufactured  in such a way as to reduce as far as 
possible and appropriate the risks posed by s ubstances that may leach or leak from 
the device. Special attention shall be give n to substances which are carcinogenic, 
mutagenic or toxic to reproduction, in acco rdance with Part 3 of Annex VI to 
Regulation (EC) No 1272/2008 of the European  Parliament and of the Council of 16 
December 2008 on classification, labelling and packaging of substances and 
mixtures, amending and repealing Dire ctives 67/548/EEC and 1999/45/EC, and 
amending Regulation (EC) No 1907/200657, and to substances having endocrine 
disrupting properties for which there is scie ntific evidence of pr obable serious effects 
to human health and which are identified in accordance with the procedure set out in 
Article 59 of Regulation (EC) No 1907/2006 of  the European Parliament and of the 
Council of 18 December 2006 concerning th e Registration, Evaluation, Authorisation 
and Restriction of Chemicals (REACH)58. 
If devices, or parts thereof, that are intended  – to be invasive devices and to come into  contact with the body of the patient for 
short- or long-term, or  
– to (re)administer medicines, body liquids  or other substances, including gases, 
to/from the body, or  
– to transport or store such medicines, body fluids or substances, including gases, 
to be (re)administered to the body  
contain, in a concentration of 0.1% by mass of the plasticised material or above, 
phthalates which are classified as carcinoge nic, mutagenic or toxic to reproduction of 
category 1A or 1B in accordance with Pa rt 3 of Annex VI to  Regulation (EC) No 
1272/2008, these devices shall be labelled on the device itself and/or on the 
packaging for each unit or, where appropria te, on the sales packaging as devices 
containing phthalates. If the intended us e of such devices includes treatment of 
children or treatment of pregnant or nursi ng women, the manufacturer shall provide a 
specific justification for the use of these s ubstances with regard to compliance with 
the general safety and performance requireme nts, in particular of this paragraph, 
within the technical document ation and, within the instruc tions for use, information 
on residual risks for these patient groups  and, if applicable, on appropriate 
precautionary measures. 
7.5. Devices shall be designed and manufactured in such a way as to reduce as far as 
possible and appropriate ri sks posed by the unintentiona l ingress or egress of 
substances into or from the device taking in to account the device and the nature of 
the environment in which it is intended to be used. 
7.6. The devices shall be designed and manufact ured in such a way as to reduce to a 
minimum the risks linked to the size and the properties of particles used. Special care 
                                                
 
57 OJ L 353, 31.12.2008, p. 1. 
58 OJ L 136, 29.5.2007, p.3.  
EN 104   EN shall be applied when devices contain or consist of nanomat erial that can be released 
into the patient’s or user's body. 
8. Infection and microbial contamination 
8.1. The devices and manufacturing processes sh all be designed in such a way as to 
eliminate or to reduce as far as possible the risk of infection to patients, users and, where applicable, other pe rsons. The design shall: 
(a) allow easy handling, 
and, where necessary, (b) reduce as far as possible and appropriate any microbial leakage from the device 
and/or microbial exposure during use, 
(c) prevent microbial contamination of the device or specimen. 
8.2. Devices labelled as having a special mi crobiological state shall be designed, 
manufactured and packaged to ensure that they remain so when placed on the market and remain so under the transport and storage conditions specified by the manufacturer. 
8.3. Devices delivered in a sterile state shall be designed, manufactured and packaged in 
a non-reusable pack, and/or a ccording to appropriate proce dures, to ensure that they 
are sterile when placed on the market a nd remain sterile, under the transport and 
storage conditions indicated by the manuf acturer, until the protective packaging is 
damaged or opened.  
8.4. Devices labelled either as sterile or as having a special microbiological state shall 
have been processed, manufactured and, if  applicable, sterilis ed by appropriate, 
validated methods. 
8.5. Devices intended to be sterilised shall be manufactured in appropriately controlled 
(e.g. environmental) conditions. 
8.6. Packaging systems for non-sterile devices shall maintain the integrity and cleanliness 
of the product and, if the devices  are to be sterilised prior to use, minimise the risk of 
microbial contamination; the packaging sy stem shall be suitable taking account of 
the method of sterilisation indicated by the manufacturer. 
8.7. The labelling of the device shall distinguish between id entical or similar products 
placed on the market in both ster ile and non-sterile condition. 
9. Devices incorporating a substance considered to be a medicinal product and 
devices composed of substances or combination of substances intended to be ingested, inhaled or administered rectally or vaginally  
9.1. In the case of devices referred to in the fi rst subparagraph of Artic le 1(4), the quality, 
safety and usefulness of the substance which, if used separately, would be considered 
to be a medicinal product within the meaning of Artic le 1 of Directive 2001/83/EC, 
shall be verified by analogy with the met hods specified in Annex I to Directive  
EN 105   EN 2001/83/EC, as laid down in the applicable conformity asse ssment procedure in this 
Regulation. 
9.2. Devices that are composed of substances or  combination of substa nces intended to be 
ingested, inhaled or administ ered rectally or vaginally and that are absorbed by or 
dispersed in the human body shall comply, by analogy, with the relevant requirements laid down in A nnex I to Directive 2001/83/EC. 
10. Devices incorporating materi als of biological origin 
10.1. For devices manufactured uti lising tissues or cells, or th eir derivatives, of human 
origin which are covered by this Regulati on in accordance with point (e) of Article 
1(2) the following applies:  
(a) Donation, procurement and testing of tissues  and cells of human  origin used for 
the manufacture of devices shall be made in accordance with Directive 
2004/23/EC. 
(b) The processing, preservation and any othe r handling of those tissues and cells 
shall be carried out so as to provide optimal safety for patients, users and, 
where applicable, other persons. In particul ar, safety with regard to viruses and 
other transmissible agents shall be a ddressed by implementation of validated 
methods of elimination or inactivation in the course of the manufacturing 
process.  
(c) It shall be ensured that the traceab ility system for de vices manufactured 
utilising those human tissues or cells is complementary and compatible with the traceability and data protection requirements laid down in Directive 2004/23/EC and in Directive 2002/98/EC of  the European Parliament and of 
the Council of 27 January 2003 setting sta ndards of quality and safety for the 
collection, testing, processing, storage and distribution of human blood and 
blood components and amending Directive 2001/83/EC
59.  
10.2. For devices manufactured uti lising tissues or cells, or th eir derivatives, of animal 
origin which are non-viable or rende red non-viable the following applies: 
(a) Where feasible taking into account the animal species, tissues and cells of 
animal origin shall originate from animals that have been subjected to veterinary controls that are adapte d to the intended use of the tissues. 
Information on the geographical origin of the animals shall be retained. 
(b) Processing, preservation, te sting and handling of tissues, cells and substances 
of animal origin shall be car ried out so as to  provide optimal safety for patients, 
users and, where applicable, other persons. In particular safety  with regard to 
viruses and other transmissi ble agents shall be addre ssed by implementation of 
validated methods of elimination or vi ral inactivation in the course of the 
manufacturing process. 
                                                
 
59 OJ L 33, 8.2.2003, p. 30.  
EN 106   EN (c) In the case of devices manufactured utilising tissues or cells of animal origin as 
referred to in Commission Regulat ion (EU) No 722/2012 of 8 August 2012 
concerning particular requirements as re gards the requirements laid down in 
Council Directives 90/385/EEC and 93/42/EEC with respect to active 
implantable medical devices and medi cal devices manufactured utilising 
tissues of animal origin60, the particular requirements laid down in that 
Regulation shall apply. 
10.3. For devices manufactured utilising othe r non-viable biologi cal substances the 
following applies:  
In the case of biological substances other than those referred to  in Sections 10.1. and 
10.2., the processing, preservation, testing and handling of those substances shall be 
carried out so as to provid e optimal safety for patients,  users and, where applicable, 
other persons. In particular, safety with regard to viruses and other transmissible 
agents shall be addressed by implementation of validated methods of elimination or 
inactivation in the course of  the manufacturing process. 
11. Interaction of devices with their environment 
11.1. If the device is intended for use in combin ation with other devices or equipment the 
whole combination, including the connection system shall be safe and shall not 
impair the specified performance of the devices. Any restrictions on use applying to such combinations shall be indicated on the label and/or in the instructions for use. 
Connections which the user ha s to handle, such as fluid, gas transfer or mechanical 
coupling, shall be designed a nd constructed in such a way as to minimize all possible 
risks from incorrect connection. 
11.2. Devices shall be designed and manufactured in such a way as to remove or reduce as 
far as possible and appropriate: 
(a) the risk of injury to the patient, user or other persons in connection with their 
physical and ergonomic features; 
(b) the risk of use error due to the er gonomic features, human factors and the 
environment in which the device is intended to be used; 
(c) risks connected with reasonably foreseeable external influences or 
environmental conditions, such as magne tic fields, external  electrical and 
electromagnetic effects, electrostatic discharge, radiation associated with 
diagnostic or therapeutic procedures , pressure, humidity, temperature, 
variations in pressure and accelera tion or radio signal interferences; 
(d) the risks associated with the use of the device when it comes into contact with 
materials, liquids, and substances, incl uding gases, to wh ich it is exposed 
during normal conditions of use; 
(e) the risk associated with the possible ne gative interaction between software and 
the environment within which it operates and interacts; 
                                                
 
60 OJ L 212, 9.8.2012, p. 3.   
EN 107   EN (f) the risks of accidental ingress of  substances into the device; 
(g) the risks of reciprocal in terference with other devices normally used in the 
investigations or for the treatment given; 
(h) risks arising where maintenance or calibration are not possible (as with 
implants), from ageing of materials used  or loss of accuracy of any measuring 
or control mechanism. 
11.3. Devices shall be designed and manufactured in such a way as to minimise the risks 
of fire or explosion during normal use a nd in single fault condition. Particular 
attention shall be pa id to devices whose intended purpose includes exposure to or use 
in association with flammable substan ces or substances which could cause 
combustion. 
11.4. Devices shall be designed and manufactur ed in such a way that adjustment, 
calibration, and maintenance, where such is  necessary to achieve the performances 
intended, can be done safely. 
11.5. Devices that are intended to be operated toge ther with other devices or products shall 
be designed and manufactured in such as way that the interoperability is reliable and 
safe. 
11.6. Any measurement, monitoring or display scale shall be designed in line with 
ergonomic principles, taking account of the intended purpose of the device. 
11.7. Devices shall be designed and manufactured in such a way as to facilitate the safe 
disposal of the device and/or of any wast e substances by the user, patient or other 
person. 
12. Devices with a diagnostic or measuring function 
12.1. Diagnostic devices and devices with a m easuring function, shall be designed and 
manufactured in such a way as to provide sufficient accuracy, pr ecision and stability 
for their intended purpose, based on appropr iate scientific and technical methods. 
The limits of accuracy shall be indicated by the manufacturer. 
12.2. The measurements made by devices with a measuring function and expressed in 
legal units shall conform to the prov isions of Council Directive 80/181/EEC61. 
13. Protection against radiation 
13.1. General 
(a) Devices shall be designed and manufactured and packaged in such a way that 
exposure of patients, users and other pe rsons to any emitted radiation shall be 
reduced as far as possible and appropr iate, compatible with the intended 
purpose, whilst not restricting the applica tion of appropriate specified levels for 
therapeutic and diagnostic purposes. 
                                                 
61 OJ L 39, 15.2.1980.  
EN 108   EN (b) The operating instructions for devices emitting radiation shall give detailed 
information as to the nature of the emitted radiation, means of protecting the 
patient and the user and on ways of a voiding misuse and of eliminating the 
risks inherent in installation. 
13.2. Intended radiation 
(a) Where devices are designed to emit h azardous, or potentially hazardous, levels 
of visible and/or invisible radiation necessary for a specific medical purpose 
the benefit of which is considered to  outweigh the risks inherent in the 
emission, it shall be possible  for the user to control the emissions. Such devices 
shall be designed and manufactured to ensure reproducibility of relevant 
variable parameters within an acceptable tolerance. 
(b) Where devices are intended to emit pot entially hazardous, visible and/or 
invisible radiation, they shall be fitte d, where possible, with visual displays 
and/or audible warnings  of such emissions. 
13.3. Unintended radiation 
Devices shall be designed and manufactured in such a way that exposure of patients, 
users and other persons to the emission of unintended, stray or sc attered radiation is 
reduced as far as possible and appropriate. 
13.4. Ionising radiation 
(a) Devices intended to emit ionising radiat ion shall be designe d and manufactured 
in such a way as to ensure that, where possible, the quantity, geometry and energy distribution (or quality) of ra diation emitted can be varied and 
controlled taking into ac count the intended use. 
(b) Devices emitting ionising radiation inte nded for diagnostic radiology shall be 
designed and manufactured in such a wa y as to achieve appropriate image 
and/or output quality for the inte nded medical purpose whilst minimising 
radiation exposure of the patient and user. 
(c) Devices emitting ionising radiation, inte nded for therapeutic radiology shall be 
designed and manufactured in  such a way as to enab le reliable monitoring and 
control of the delivered dose, the beam  characteristics in terms of type of 
radiations, energy and, where appr opriate, energy distribution. 
14. Software incorporated in devices and standalone software 
14.1. Devices that incorporate electronic progr ammable systems, including software, or 
standalone software that are devices in themselves, shall be designed to ensure repeatability, reliability and performance a ccording to the intended use. In the event 
of a single fault condition, a ppropriate means shall be adopt ed to eliminate or reduce 
as far as possible and appr opriate consequent risks. 
14.2. For devices that incorporate software or fo r standalone software that are devices in 
themselves, the software shall be develope d and manufactured according to the state  
EN 109   EN of the art taking into account the princi ples of development life cycle, risk 
management, verification and validation. 
14.3. Software referred to in this Section that ar e intended to be used in combination with 
mobile computing platforms shall be design ed and manufactured taking into account 
the specific features of the mobile platform (e.g. size and contrast ratio of the screen) 
and the external factors related to their us e (varying environment as regards to level 
of light or noise). 
15. Active devices and devices connected to them  
15.1. For active devices, in the even t of a single fault condition, appropriate means shall be 
adopted to eliminate or reduce as far as possible and appropriate consequent risks. 
15.2. Devices where the safety of the patients depends on an in ternal power su pply shall be 
equipped with a means of determining the state of the power supply. 
15.3. Devices where the safety of the patients depends on an external  power supply shall 
include an alarm system to  signal any power failure. 
15.4. Devices intended to monitor one or more c linical parameters of a patient shall be 
equipped with appropriate alarm systems to alert the user of situations which could 
lead to death or severe deteriorati on of the patient's state of health. 
15.5. Devices shall be designed and manufactured in such a way as to reduce as far as 
possible and appropriate the risks of cr eating electromagnetic  interference which 
could impair the operation of this or ot her devices or equipm ent in the intended 
environment. 
15.6. Devices shall be designed and manufactured in such a way as to provide an adequate 
level of intrinsic immunity to electromagnetic disturbance to enable them to operate as intended. 
15.7. Devices shall be designed a nd manufactured in such a wa y as to avoid, as far as 
possible, the risk of accidental electric shocks to the patien t, user or any other person, 
both during normal use of the device and in  the event of a single fault condition in 
the device, provided the device is insta lled and maintained as indicated by the 
manufacturer. 
16. Protection against mechanic al and thermal risks 
16.1. Devices shall be designed a nd manufactured in such a way as to protect the patient 
and user against mechanical risks connected with, for example, resistance to movement, instability and moving parts. 
16.2. Devices shall be designed and manufactured in such a way as to reduce to the lowest 
possible level the risks arising from vi bration generated by the devices, taking 
account of technical progress and of the means available for limiting vibrations, 
particularly at source, unle ss the vibrations are part of  the specified performance. 
16.3. Devices shall be designed and manufactured in such a way as to reduce to the lowest 
possible level the risks arising from th e noise emitted, taking account of technical  
EN 110   EN progress and of the means available to reduc e noise, particularly at source, unless the 
noise emitted is part of the specified performance. 
16.4. Terminals and connectors to the electric ity, gas or hydraulic and pneumatic energy 
supplies which the user or other pers on has to handle shall be designed and 
constructed in such a way as to  minimise all possible risks. 
16.5. Errors likely to be made when fitting or  refitting, or connecting or reconnecting, 
certain parts before or duri ng use which could be a source  of risk must be made 
impossible by the design and construction of such parts or, failing this, by 
information given on the parts th emselves and/or their housings. 
The same information must be given on m oving parts and/or th eir housings where 
the direction of movement needs to be known in order to avoid a risk. 
16.6. Accessible parts of the devices (excluding th e parts or areas intended to supply heat 
or reach given temperatures) and their surroundings shall not attain potentially 
dangerous temperatures under normal conditions of use. 
17. Protection against the risks posed to the patient or user by supplied energy or 
substances 
17.1. Devices for supplying the patient with ener gy or substances sh all be designed and 
constructed in such a way that the deli vered amount can be set and maintained 
accurately enough to assure the safety  of the patient and of the user. 
17.2. Devices shall be fitted with the mean s of preventing and/or indicating any 
inadequacies in the delivered amount wh ich could pose a danger. Devices shall 
incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy or substances from an energy and/or substance source. 
17.3. The function of the controls and indicators shall be clearly specified on the devices. 
Where a device bears instructions required for its operation or i ndicates operating or 
adjustment parameters by means of a visu al system, such information shall be 
understandable to the user and, as appropriate, the patient. 
18. Protection against the risks posed by medical devices intended by the 
manufacturer for use by lay persons  
18.1. Devices for use by lay persons  shall be designed and ma nufactured in such a way 
that they perform appropria tely for their in tended purpose taking into account the 
skills and the means available to lay pe rsons and the influence resulting from 
variation that can reasonabl y be anticipated in the lay person’s technique and 
environment. The information and instructi ons provided by the ma nufacturer shall be 
easy for the lay person to understand and apply. 
18.2. Devices for use by lay persons  shall be designed and manufactured in such a way as 
to  
–
 ensure that the device is easy to use by the intended user at all stages of the 
procedure, and  
EN 111   EN – reduce as far as possible the risk of erro r by the intended user in the handling of 
the device and, if applicable, in the interpretation of the results. 
18.3. Devices for use by lay persons  shall, where reasonably possi ble, include a procedure 
by which the lay person 
– can verify that, at the time of use, the device will perform as intended by the 
manufacturer, and 
– if applicable, is warned if the devi ce has failed to provide a valid result. 
III. Requirements regarding the information supplied with the device 
19. Label and instructions for use 
19.1. General requirements regarding the info rmation supplied by the manufacturer  
Each device shall be accompanied by the in formation needed to identify the device 
and its manufacturer, and communicate safe ty and performance related information 
to the user, professional or lay, or other person, as appropriate. Such information may 
appear on the device itself, on the packaging or  in the instructions for use, taking into 
account the following:  
(a) The medium, format, content, legibility, and location of the label and 
instructions for use shall be appropriate to the part icular device, its intended 
purpose and the technical knowledge, expe rience, education or training of the 
intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams. Some devi ces may include separate information 
for the professional user and the lay person. 
(b) The information required on the label shall be provided on the device itself. If 
this is not practicable or appropriate, so me or all of the information may appear 
on the packaging for each unit, and/or on the packaging of multiple devices. 
Where multiple devices are supplied to a single user and/or location, a single 
copy of the instructions for use may be provided if so agr eed by the purchaser 
who in any case may request further copies to be provided.  
(c) For devices of class I and IIa, instructi ons for use are not needed or may be 
abbreviated if the device can be used safely and as intended by the manufacturer without any su ch instructions for use. 
(d) Labels shall be provided in a human-read able format but may be supplemented 
by machine-readable forms, such as ra dio-frequency identification (RFID) or 
bar codes. 
(e) Instructions for use may be provided to  the user in non-paper format (e.g. 
electronic) to the extent and under the conditions set out in Commission  
EN 112   EN Regulation (EU) No 207/2012 on electronic instructions for use of medical 
devices62.  
(f) Residual risks which are required to be communicated to the user and/or other 
person shall be included as limitations, contraindications, precautions or warnings in the information supplied by the manufacturer. 
(g) Where appropriate, this information shoul d take the form of internationally 
recognised symbols. Any sym bol or identification colour used shall conform to 
the harmonised standards or CTS. In areas for which no standards or CTS 
exist, the symbols and col ours shall be described in the documentation supplied 
with the device.  
19.2. Information on the label  
The label shall bear the following particulars: 
(a) The name or trade name of the device.  
(b) The details strictly necessary for a user to identify the device, the contents of 
the packaging and, where it is not obvious  for the user, the intended purpose of 
the device. 
(c) The name, registered trade name or regi stered trade mark of the manufacturer 
and the address of his regist ered place of business at which he can be contacted 
and his location be established. 
(d) For imported devices, the name, registered trade name or registered trade mark 
of the authorised representative established within the Union and the address of his registered place of business at whic h he can be contacted and his location 
be established.  
(e) Where applicable, an indication that th e device contains or incorporates  
– a medicinal substance, including a hu man blood or plasma derivative, or 
– tissues or cells, or their deri vatives, of human origin, or 
– tissues or cells, or their derivatives, of animal origin as referred to in 
Commission Regulati on (EU) No 722/2012. 
(f) Where applicable, an indication that the device incorporates or consists of 
nanomaterial unless the nanomaterial is encapsulated or bound in such a manner that it cannot be released into the patient’s or user's body when the device is used within its intended purpose. 
(g) The batch code/lot number or the serial  number of the device preceded by the 
word LOT or SERIAL NUMBER or an equivalent symbol, as appropriate. 
                                                
 
62 OJ L 72, 10.3.2012, p. 28.  
EN 113   EN (h) Where applicable, the unique device identification (UDI). 
(i) An unambiguous indication of the date until when the device may be used 
safely, expressed at least as the year  and month, where this is relevant.  
(j) Where there is no indication of the date until when it may be used safely, the 
year of manufacture. This year of ma nufacture may be included as part of the 
batch or serial number, provided th e date is clearly identifiable. 
(k) An indication of any speci al storage and/or handli ng condition that applies. 
(l) If the device is supplied sterile, an indication of its sterile state and the 
sterilisation method. 
(m) Warnings or precautions to be taken that need to be brought to the immediate 
attention of the user of the device as  relevant, and to any other person where 
appropriate. This information may be ke pt to a minimum in which case more 
detailed information should appear in the instructions for use. 
(n) If the device is intended for single use, an indication of that fact. A 
manufacturer's indication of single use shall be consistent across the Union. 
(o) If the device is a single use device that  has been reprocessed, an indication of 
that fact, the number of reprocessi ng cycles already performed, and any 
limitation as regards the number  of reprocessing cycles.  
(p) If the device is custom made, an indication of that fact. 
(q) If the device is intended for clinical investigation only, an indication of that 
fact. 
19.3. Information in the instructions for use 
The instructions for use shall co ntain the following particulars: 
(a) The particulars referred to in point s 19.2. a), c), e), f), k), l) and n). 
(b) The device’s intended purpose including the intended user (e.g. professional or 
lay person), as appropriate.  
(c) The performance of the device intended by the manufacturer. 
(d) Any residual risks, cont raindications and any expected and foreseeable 
undesirable side-effects, incl uding information to be c onveyed to the patient in 
this regard. 
(e) Specifications the user requires to use the device appropriately, e.g. if the 
device has a measuring function, the de gree of accuracy claimed for it.  
(f) Details of any preparatory treatment or ha ndling of the device before it is ready 
for use (e.g. sterilisation, fina l assembly, calibration, etc.).  
EN 114   EN (g) Any requirements for special facilities , or special training, or particular 
qualifications of the device user and/or other persons. 
(h) The information needed to verify whethe r the device is properl y installed and is 
ready to perform safely and as inte nded by the manufacturer, together with, 
where relevant: 
– details of the nature, and freque ncy, of preventative and regular 
maintenance, and of any prepar atory cleaning or disinfection;  
– identification of any consumable components and how to replace them;  
– information on any necessary calibra tion to ensure that the device 
operates properly and safely during its intended lifetime ; 
– methods of eliminating the risks encountered by persons involved in 
installing, calibrating or servicing devices. 
(i) If the device is supplied sterile, instructions in the event of the sterile 
packaging being damaged before use.  
(j) If the device is supplied non- sterile with the intention th at it is sterilised before 
use, the appropriate instructions for sterilisation. 
(k) If the device is reusable, informati on on the appropriate processes to allow 
reuse, including cleaning, disinfection, decontamination, packaging and, where 
appropriate, the validated method of re -sterilisation. Information should be 
provided to identify when the device s hould no longer be reused, e.g. signs of 
material degradation or the maxi mum number of allowable reuses. 
(l) If the device bears an indication that th e device is for single use, information 
on known characteristics and technical fact ors known to the manufacturer that 
could pose a risk if the device were to be  re-used. If in accordance with point c) 
of Section 19.1 no instructions for use are needed, the information shall be 
made available to the user upon request. 
(m) For devices intended for use together with  other devices and/or general purpose 
equipment: 
– information to identify such devices or equipment, in order to obtain a 
safe combination, and/or 
– information on any known restrictions  to combinations of devices and 
equipment. 
(n) If the device emits hazardous, or potent ially hazardous levels  of radiation for 
medical purposes:  
– detailed information as to the nature, type and where appropriate, the 
intensity and distribution of the emitted radiation;  
EN 115   EN – the means of protecting the patient, user, or other person from unintended 
radiation during use of the device. 
(o) Information that allows the user and/or patient to be informed of any warnings, 
precautions, measures to be taken and limitations of use regarding the device. This information should cover, where appropriate: 
– warnings, precautions and/or measures to be taken in the event of 
malfunction of the device or changes in  its performance that may affect 
safety; 
– warnings, precautions and/or measures  to be taken in regards to the 
exposure to reasonably foreseeable exte rnal influences or environmental 
conditions, such as magnetic fi elds, external electrical and 
electromagnetic effects, electrostatic discharge, radiation associated with 
diagnostic or therapeutic procedures, pressure, humidity, or temperature; 
– warnings, precautions and/or measures to  be taken in rega rds to the risks 
of interference posed by the reasona bly foreseeable presence of the 
device during specific diagnostic investigations, evaluations, or 
therapeutic treatment or other procedures (e.g. electromagnetic 
interference emitted by the device affecting other equipment); 
– if the device is intended to administer  medicinal products, tissues or cells, 
or their derivatives, of human or anim al origin or biological substances, 
any limitations or incompatibility in  the choice of substances to be 
delivered; 
– warnings, precautions and/or limita tions related to the medicinal 
substance or biological material that is  incorporated into the device as an 
integral part of the device; 
– precautions related to materials incorporated into the device that are 
carcinogenic, mutagenic or toxic, or  that have endocrine disrupting 
properties or that could re sult in sensitisation or allergic reaction of the 
patient or user. 
(p) Warnings or precautions to be taken in or der to facilitate the safe disposal of 
the device, its accessories and the consum ables used with it, if any. This 
information should cover, where appropriate: 
– infection or microbial hazards (e.g. explants, needles or surgical 
equipment contaminated with potential ly infectious substances of human 
origin); 
– physical hazards (e.g. from sharps). 
(q) For devices intended for use by lay persons, the circumstances when the user 
should consult with a he althcare professional.  
EN 116   EN (r) For devices listed in Annex XV for whic h the manufacturer  does not claim a 
medical purpose, information regarding th e absence of a clinical benefit and 
the risks related to the use of the device. 
(s) Date of issue of the instructions for use or, if they have been revised, date of 
issue and identifier of the latest re vision of the instructions for use. 
(t) A notice to the user and/or patient that any serious incident that has occurred in 
relation to the device should be reported to the manufacturer and the competent 
authority of the Member State where the user and/or patient is established.   
EN 117   EN ANNEX II  
TECHNICAL  DOCUMENTATION 
The technical documentation and, if applic able, the summary technical documentation 
(STED) to be drawn up by the manufacturer shall include in particular the following 
elements: 
1. DEVICE DESCRIPTION AND SPECIFICATION , INCLUDING VARIANTS AND 
ACCESSORIES  
1.1. Device description and specification 
(a) product or trade name and a general de scription of the device including its 
intended purpose, 
(b) the UDI device identifier as referred to in  item (i) of point (a) of Article 24(1) 
attributed by the manufacturer to the device in question, as soon as 
identification of this devi ce shall be based on a UDI system, or otherwise clear 
identification by means of product code, catalogue nu mber or other 
unambiguous reference allowing traceability; 
(c) the intended patient population and medi cal condition to be diagnosed and/or 
treated and other consid erations such as patient selection criteria; 
(d) principles of operation of the device; 
(e) risk class and the applicable classi fication rule according to Annex VII; 
(f) an explanation of any novel features; 
(g) a description of th e accessories, other medical de vices and other products that 
are not medical devices, which are intended to be used in combination with it; 
(h) a description or complete list of the various configuratio ns/variants of the 
device that will be made available;  
(i) a general description of the key functi onal elements, e.g. its parts/components 
(including software if appropriate),  its formulation, its composition, its 
functionality. Where appropriate, this  shall include labelled pictorial 
representations (e.g. diagrams, photographs , and drawings), clearly indicating 
key parts/components, including suffi cient explanation to understand the 
drawings and diagrams; 
(j) a description of the (raw) materials inco rporated into key functional elements 
and those making either direct contact with the human body or indirect contact 
with the body, e.g., during extracorpo real circulation of body fluids; 
(k) technical specifications (f eatures, dimensions and performance attributes) of 
the medical device and any variants a nd accessories that would typically  
EN 118   EN appear in the product specification ma de available to the user, e.g. in 
brochures, catalogues and the like. 
1.2. Reference to previous and simila r generations of the device  
(a) an overview of the manufacturer’s previous  generation(s) of the device, if such 
exist;  
(b) an overview of the manufacturer’s sim ilar devices available on the EU or 
international markets, if such exist. 
2. INFORMATION SUPPLIED BY THE MANUFACTURER  
(a) a complete set of  
– the label(s) on the device and on its packaging; 
– the instructions for use; 
(b) a list of the language  variants for the Member States where the device is 
envisaged to be marketed. 
3. DESIGN AND MANUFACTURING INFORMATION  
(a) Information to allow a general understandi ng of the design stages applied to the 
device and the manufacturing processes such as production, assembly, final 
product testing, and packaging of the finished device. More detailed 
information needs to be provided for the audit of the quality management 
system or other applicable conf ormity assessment procedures;  
(b) identification of all sites, including suppliers and sub- contractors, where design 
and manufacturing activ ities are performed.  
4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS  
The documentation shall contain information regarding the solutions adopted to meet 
the general safety and performance requi rements laid down in Annex I. This 
information may take the form  of a checklist identifying  
(a) the general safety and performance requi rements that apply to the device and 
why others do not apply; 
(b) the method(s) used to demonstrate conformity with each applicable general 
safety and performance requirement;  
(c) the harmonised standards or CTS app lied or other method(s) employed; 
(d) the precise identity of the contro lled documents offe ring evidence of 
conformity with each harmonised standard, CTS or other method employed to demonstrate conformity with the genera l safety and performance requirements.  
EN 119   EN This information shall incorporate a cross-reference to the location of such 
evidence within the full technical documentation and, if applicable, the 
summary technical documentation.  
5. RISK/BENEFIT ANALYSIS AND RISK MANAGEMENT  
The documentation shall contain a summary of  
(a) the risk/benefit analysis referred to in  Sections 1 and 5 of Annex I, and  
(b) the solutions adopted and the results of the risk management referred to in 
Section 2 of Annex I. 
6. PRODUCT VERIFICATION AND VALIDATION  
The documentation shall contain the results  of verification a nd validation testing 
and/or studies undertaken to demonstrat e conformity of the device with the 
requirements of this Regulation and in part icular the applicable general safety and 
performance requirements.  
6.1. Pre-clinical and clinical data  
(a) results of (engineering, laboratory, simula ted use, animal) tests and evaluation 
of published literature applicable to th e device or substantia lly similar devices 
regarding the pre-clinical safety of th e device and its conformity with the 
specifications;  
(b) detailed information regarding test de sign, complete test or study protocols, 
methods of data analysis, in addition to data summari es and test conclusions 
regarding  
– biocompatibility (identifying all materi als in direct or indirect contact 
with the patient or user); 
– physical, chemical and microbi ological characterisation; 
– electrical safety and electromagnetic compatibility; 
– software verification and validation (d escribing the software design and 
development process and evidence of the validation of the software, as 
used in the finished device. This in formation should typically include the 
summary results of all verification, validation and testing performed both 
in-house and in a simulated or actua l user environment prior to final 
release. It should also ad dress all of the different hardware configurations 
and, where applicable, operating system s identified in the information 
supplied by the manufacturer);  
– stability/shelf life.  
EN 120   EN Where applicable, conformity with th e provisions of Directive 2004/10/EC of 
the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and ad ministrative provisions relating to the 
application of the principles of good la boratory practice and the verification of 
their applications for tests on chemical substances
63 shall be demonstrated.  
Where no new testing has been undertaken, the documentation shall 
incorporate a rationale for that decisi on, e.g. biocompatibility testing on the 
identical materials was conducted when th ese were incorporated in a previous 
version of the device that has been le gally placed on the market or put into 
service;  
(c) the report on the clinical evaluation in  accordance with Article 49(5) and Part 
A of Annex XIII; 
(d) the PMCF plan and PMCF evaluation report in accordance with Part B of 
Annex XIII or any justif ication why a PMCF is not deemed necessary or 
appropriate. 
6.2. Additional information in specific cases 
(a) Where a device incorporates, as an integral part, a substance which, if used 
separately, may be considered to be a medicinal product within the meaning of 
Article 1 of Directive 2001/83/EC, incl uding a medicinal pr oduct derived from 
human blood or human plasma, referred to in the first subpar agraph of Article 
1(4), a statement indicating this fact. In this case, the documentation shall 
identify the source of that substance and contain the data of the tests conducted 
to assess its safety, quality and usef ulness, taking account of the intended 
purpose of the device. 
(b) Where a device is manufactured utilising tis sues or cells of human or animal 
origin, or their derivatives, that are covered by this Regulation in accordance 
with point (e) of Article 1(2), a statemen t indicating this fact. In this case, the 
documentation shall identify all materials of human or animal origin used and provide detailed information concerning th e conformity with Sections 10.1. or 
10.2., respectively, of Annex I.  
(c) In the case of devices placed on the market in a sterile or defined 
microbiological condition a description of the environmental conditions for the 
relevant manufacturing steps. In the cas e of devices placed on the market in a 
sterile condition, a descri ption of the methods used, including the validation 
reports, with respect to packaging, ster ilisation and maintenance of sterility. 
The validation report shall address biobur den testing, pyroge n testing and, if 
applicable, testing for sterilant residues.  
(d) In the case of devices placed on the market with a measuring function, a 
description of the methods used in order to ensure the accuracy as given in the 
specifications. 
                                                
 
63 OJ L 50, 20.2.2004, p. 44.  
EN 121   EN (e) If the device is to be connected to other device(s) in order to operate as 
intended, a description of th is combination including proof  that it conforms to 
the general safety and performance requi rements when connected to any such 
device(s) having regard to the charact eristics specified by the manufacturer.  
EN 122   EN ANNEX III 
EU DECLARATION  OF CONFORMITY 
1. Name, registered trade name or registered  trade mark of the manufacturer and, if 
applicable, his authorised representative, a nd the address of their registered place of 
business where they can be contacted and their location be established; 
2. A statement that the declara tion of conformity is issued  under the sole responsibility 
of the manufacturer; 
3. The UDI device identifier as referred to in item (i) of point (a) of Article 24(1) as 
soon as identification of the device that is  covered by the declaration shall be based 
on a UDI system;  
4. Product or trade name, product code, cat alogue number or other unambiguous 
reference allowing identification and traceabil ity of the device that is covered by the 
declaration (it may include a photograph, where appropriate). Except for the product 
or trade name, the information allowing identification and traceability may be 
provided by the device identifier referred to in point 3;  
5. Risk class of the device in accordance with Annex VII; 
6. A statement that the device that is covered by  the present declarati on is in conformity 
with this Regulation and, if applicable, w ith other relevant Un ion legislation that 
make provision for the issuing of a declaration of conformity;  
7. References to the relevant harmonised stan dards or CTS used in relation to which 
conformity is declared; 
8. Where applicable, name and identificatio n number of the notif ied body, description 
of the conformity assessment procedur e performed and identification of the 
certificate(s) issued; 
9. Where applicable, additional information; 
10. Place and date of issue, name and function of the person who signs as well as 
indication for and on behalf of whom he/she signs, signature.  
EN 123   EN ANNEX IV 
CE MARKING  OF CONFORMITY 
1. The CE marking shall consist of the in itials ‘CE’ taking the following form:  
 
2. If the CE marking is reduced or enla rged the proportions given in the above 
graduated drawing shall be respected. 
3. The various components of the CE marking sh all have substantially  the same vertical 
dimension, which may not be less than 5 mm. This minimum dimension may be 
waived for small-scale devices.  
EN 124   EN ANNEX V 
INFORMATION  TO BE SUBMITTED  WITH  THE  REGISTRATION  OF 
DEVICES  AND  ECONOMIC  OPERATORS  IN ACCORDANCE  WITH  
ARTICLE  25 
AND   
DATA  ELEMENTS  OF THE  UDI  DEVICE  IDENTIFIER  IN 
ACCORDANCE   
WITH  ARTICLE  24 
PART A 
INFORMATION TO BE SUBMITTED WITH THE REGISTRATION OF DEVICES IN ACCORDANCE 
WITH ARTICLE 25  
Manufacturers or, when applicable, authoris ed representatives, and, when applicable, 
importers shall submit the following information: 
1. economic operator's role (manufacturer, aut horised representative, or importer),  
2. name, address and contact details of the economic operator, 
3. where submission of information is comple ted by another person on behalf of any of 
the economic operators mentioned under poi nt 1, the name, address and contact 
details of this person, 
4. UDI device identifier, or wher e identification of the device  is not yet based on a UDI 
system, the data elements laid down in points 5 to 21 of Part B of this Annex, 
5. type, number and expiry date of certificate and name or identification number of the 
notified body that has issued the certif icate (and link to the information on the 
certificate entered by the notif ied body in the electronic system on certificates), 
6. Member State where the device shall or ha s been placed on the market in the Union, 
7. in case of devices classified as classes IIa, IIb or III: Member States where the device 
is or shall be made available, 
8. in case of imported devi ce: country of origin, 
9. risk class of the device, 
10. reprocessed single use device (y/n), 
11. presence of a substance which, if used separately, may be considered to be a 
medicinal product and name of this substance,  
EN 125   EN 12. presence of a substance whic h, if used separately, may be considered a medicinal 
product derived from human blood or human plasma and name of this substance, 
13. presence of human tissues or ce lls, or their derivatives (y/n), 
14. presence of animal tissues or cells, or th eir derivatives, as referred to in Commission 
Regulation (EU) No 722/2012 (y/n), 
15. where applicable, single identification number of the clinical investigation(s) 
conducted in relation to the device (or link to  the clinical investigation registration in 
the electronic system regardi ng clinical inve stigations), 
16. in case of devices listed in Annex XV, sp ecification whether the intended purpose of 
the device is other than a medical purpose,  
17. in case of devices designed and manufactur ed by another legal or natural person as 
referred in Article 8(10), the name, address a nd contact details of that legal or natural 
person,  
18. in case of devices classified as class III or implantable devices, the summary of 
safety and clinical performance, 
19. status of the device (on the market, no longer manufactured, withdrawn from the 
market, recalled). 
PART B 
DATA ELEMENTS OF THE UDI  DEVICE IDENTIFIER IN ACCORDANCE WITH ARTICLE 24 
The UDI device identifier shall provide access to the following information related to the 
manufacturer and the device model: 
1. quantity per package configuration, 
2. if applicable, alternative or additional identifier(s),  
3. the way how the device production is controlled (expiration date or manufacturing date, 
lot or batch number, serialisation number),  
4. if applicable, the unit of use device identifier (when a UDI is not assigned to the device 
at the level of its unit of use, a 'unit of use'  device identifier shall be assigned to associate 
the use of a device with a patient),  
5. name and address of the manufact urer (as indicated on the label), 
6. if applicable, name and address of the au thorised representative (as indicated on the 
label), 
7. Global Medical Device Nomenc lature (GMDN) code or internationally recognised 
nomenclature code, 
8. if applicable, trade/brand name,  
EN 126   EN 9. if applicable, device model, re ference, or catalogue number, 
10. if applicable, clinical size (incl uding volume, length, gauge, diameter), 
11. additional product desc ription (optional), 
12. if applicable, storag e and/or handling condi tions (as indicated on the label or in the 
instructions for use), 
13. if applicable, additional tr ade names of the device,  
14. labelled as single use device (y/n), 
15. if applicable, restricted number of reuses, 
16. device packaged sterile (y/n), 
17. need for sterilisation before use (y/n), 
18. labelled as containing latex (y/n), 
19. labelled as containing DEHP (y/n), 
20. URL for additional information, e.g. electr onic instructions for use (optional), 
21. if applicable, critical warn ings or contraindications.  
EN 127   EN ANNEX VI  
MINIMUM  REQUIREMENTS  TO BE MET  BY NOTIFIED  BODIES 
1. ORGANISATIONAL AND GENERAL REQUIREMENTS  
1.1. Legal status and organisational structure  
1.1.1.  A notified body shall be esta blished under the national law of a Member State, or 
under the law of a third country  with which the Union has concluded an agreement in 
this respect, and shall have full documentati on of its legal personality and status. This 
shall include information about ownership a nd the legal or natura l persons exercising 
control over the notified body.  
1.1.2.  If the notified body is a legal en tity that is part of a larg er organisation, the activities 
of this organisation as well as its orga nisational structure and governance, and the 
relationship with the notified body shall be clearly documented. 
1.1.3.  If the notified body wholly or partly owns legal entities established in a Member 
State or in a third country, the activities and responsibilities of those entities, as well 
as their legal and operational relationships  with the notified body, shall be clearly 
defined and documented. 
1.1.4.  The organisational structure,  distribution of responsibilities and operation of the 
notified body shall be such that it assure s confidence in the performance and results 
of the conformity assessment activities conducted.  
The organisational structure and the functi ons, responsibilities and authority of its 
top-level management and of other pers onnel with influence upon the performance 
and results of the conformity assessment activities shall be clearly documented. 
1.2. Independence and impartiality 
1.2.1.  The notified body shall be a third-party body th at is independent of the manufacturer 
of the product in relation to which it perf orms conformity assessment activities. The 
notified body shall also be independent of  any other economic operator having an 
interest in the product as well as of any competitor of the manufacturer.  
1.2.2.  The notified body shall be organised a nd operated so as to safeguard the 
independence, objectivity and impartiality of its activities. The notified body shall 
have procedures in place that effectivel y ensure identification, investigation and 
resolution of any case in which a conflict of interests may arise, including involvement in consultancy serv ices in the field of medica l devices prior to taking up 
employment with the notified body. 
1.2.3.  The notified body, its top-level manageme nt and the personnel responsible for 
carrying out the conformity assessment tasks shall not  
– be the designer, manufacturer, supplier, installer, purchaser, owner, user or 
maintainer of the products, nor the auth orised representative of any of those  
EN 128   EN parties. This shall not preclude the purc hase and use of assessed products that 
are necessary for the operations of the notified body (e.g. measuring 
equipment), the conduct of the confor mity assessment or the use of such 
products for personal purposes; 
– be directly involved in th e design, manufacture or c onstruction, the marketing, 
installation, use or maintena nce of the products which th ey assess, or represent 
the parties engaged in thos e activities. They shall not engage in any activity 
that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified;  
– offer or provide any service which ma y jeopardise the confidence in their 
independence, impartiality or objectivity. In particular, they shall not offer or 
provide consultancy services to the manu facturer, his authorised representative, 
a supplier or a commercial competitor  as regards the design, construction, 
marketing or maintenance of the products  or processes under assessment. This 
does not preclude general training ac tivities relating to medical device 
regulations or related standards that are not client specific.  
1.2.4.  The impartiality of the notified bodies, of  their top level management and of the 
assessment personnel shall be guarantee d. The remuneration of the top level 
management and assessment personnel of a notified body shall not depend on the results of the assessments. 
1.2.5.  If a notified body is owned by a public en tity or institution, independence and 
absence of any conflict of interests must be ensured and documented between, on the one hand, the national authority responsible  for notified bodies and/or competent 
authority and, on the othe r hand, the notified body.  
1.2.6.  The notified body shall ensure and document that  the activities of its  subsidiaries or 
subcontractors, or of any a ssociated body, do not affect its independence, impartiality 
or objectivity of its conform ity assessment activities.  
1.2.7.  The notified body shall operate in accordance  with a set of consistent, fair and 
reasonable terms and conditions, taking in to account the interests of small and 
medium-sized enterprises as de fined by Commission Recommendation 
2003/361/EC. 
1.2.8.  The requirements of this section in no way preclude exchanges of technical 
information and regulatory guidance be tween a notified body and a manufacturer 
seeking their conformity assessment. 
1.3. Confidentiality  
The personnel of a notified body shall observe professional secrecy w ith regard to all 
information obtained in carrying out thei r tasks under this Regulation, except in 
relation to the national authorities re sponsible for notified bodies, competent 
authorities or the Commission. Proprietary righ ts shall be protected. To this end, the 
notified body shall have documen ted procedures in place.  
EN 129   EN 1.4. Liability 
The notified body shall take out appropriate liability insurance that corresponds to 
the conformity assessment activities for which it is notified, including the possible suspension, restriction or wit hdrawal of certificates, and the geographic scope of its 
activities, unless liability is assumed by th e State in accordance with national law, or 
the Member State itself is directly res ponsible for the conformity assessment.  
1.5. Financial requirements 
The notified body shall have at its dispos al the financial resources required to 
conduct its conformity assessment activities and related business operations. It shall 
document and provide evidence of its financial capacity and its sustainable economic viability, taking into account specific circumstances duri ng an initial start-up phase. 
1.6. Participation in coordination activities 
1.6.1.  The notified body shall participate in, or ensure that its a ssessment personnel is 
informed of the relevant standardisation activities and the activities of the notified 
body coordination group and that its asse ssment and decision making personnel are 
informed of all relevant le gislation, guidance and best practice documents adopted in 
the framework of this Regulation.  
1.6.2.  The notified body shall adhere to a code of  conduct, addressing among other things, 
ethical business practices for notified bodies in the field of medi cal devices that is 
accepted by the national authorities respons ible for notified bodies. The code of 
conduct shall provide for a mechanism of  monitoring and verification of its 
implementation by notified bodies. 
2. Q
UALITY MANAGEMENT REQUIREMENTS  
2.1. The notified body shall establish, document,  implement, maintain and operate a 
quality management system that is appropr iate to the nature, area and scale of its 
conformity assessment activ ities and capable of suppor ting and demonstrating the 
consistent achievement of the re quirements of this Regulation.  
2.2. The quality management system of the notified body shall at least address the 
following: 
– policies for assignment of personnel to activities and their responsibilities; 
– decision-making process in accordance with the tasks, responsibilities and role 
of the top-level management and other notified body personnel; 
– control of documents;  
– control of records;  
– management review;  
– internal audits;   
EN 130   EN – corrective and preventive actions;  
– complaints and appeals. 
3. RESOURCE REQUIREMENTS  
3.1. General 
3.1.1.  A notified body shall be capable  of carrying out all the ta sks assigned to it by this 
Regulation with the highest degree of professional integrity  and the requisite 
technical competence in the specific field, whether those tasks are carried out by the 
notified body itself or on its beha lf and under its responsibility.  
In particular, it shall have the necessary pe rsonnel and shall possess or have access to 
all equipment and facilities needed to perform properly the technical and 
administrative tasks entailed in the conformity assessment activities in relation to which it has been notified.  
This presupposes the availability within its organisation of sufficient scientific 
personnel who possess experience and knowledge  sufficient to assess the medical 
functionality and performa nce of devices for which it has been notified, having 
regard to the requirements of  this Regulation and, in pa rticular, those set out in 
Annex I. 
3.1.2.  At all times and for each conformity asse ssment procedure and each kind or category 
of products in relation to wh ich it has been notified, a no tified body shall have within 
its organisation the necessary administrative , technical and scientific personnel with 
technical knowledge and sufficient and a ppropriate experience relating to medical 
devices and the corresponding technologies to perform the conformity assessment 
tasks, including the assessment of clinical data. 
3.1.3.  The notified body shall clearly document the extent and the limits of the duties, 
responsibilities and authoritie s in relation of the personn el involved in conformity 
assessment activities and inform th e personnel concerned about it.  
3.2. Qualification criteria in relation to personnel  
3.2.1.  The Notified Body shall establish and documen t qualification criteria and procedures 
for selection and authoris ation of persons involved in conformity assessment 
activities (knowledge, experience and other competen ce required) and the required 
training (initial and ongoing training). The qua lification criteria shall address the 
various functions within the conformity assessment process (e.g. auditing, product 
evaluation/testing, design dossier/file re view, decision-making) as well as the 
devices, technologies and areas (e.g. biocompatibility, steri lisation, tissues and cells 
of human and animal origin, clinical evaluation) covered by the scope of designation. 
3.2.2.  The qualification criteria sha ll refer to the scope of th e notified body's designation in 
accordance with the scope description used by the Member State for the notification 
referred to in Article 33, providing suffi cient level of detail for the required 
qualification within the subdivisi ons of the scope description.   
EN 131   EN Specific qualification criteria shall be defined for the assessment of biocompatibility 
aspects, clinical evaluation and the diffe rent types of steri lisation processes. 
3.2.3.  The personnel responsible for authorising other pers onnel to perform specific 
conformity assessment activities and the pers onnel with overall re sponsibility for the 
final review and decision-making on certif ication shall be employed by the notified 
body itself and shall not be subcontracted. These personnel alt ogether shall have 
proven knowledge and experience in the following: 
– Union medical devices legislation and relevant guidance documents; 
– the conformity assessment procedures in accordance with this Regulation; 
– a broad base of medical device technologi es, the medical device industry and 
the design and manufactur e of medical devices; 
– the notified body’s quality management system and related procedures; 
– the types of qualifications (knowledge , experience and other competence) 
required for carrying out conformity asse ssments in relation to medical devices 
as well as the relevant qualification criteria; 
– training relevant to personnel involved in  conformity assessment activities in 
relation to medical devices; 
– the ability to draw up certificates, reco rds and reports demonstrating that the 
conformity assessments have b een appropriately carried out. 
3.2.4.  Notified bodies shall have available personnel with clinical expertise. This personnel 
shall be integrated in the notified body's decision-making process in a steady way in 
order to: 
– identify when specialist input is requi red for the assessmen t of the clinical 
evaluation conducted by the manufacturer and identify appropriately qualified 
experts; 
– appropriately train external clinical expe rts in the relevant requirements of this 
Regulation, delegated and/or implemen ting acts, harmonised standards, CTS 
and guidance documents and ensure that th e external clinical  experts are fully 
aware of the context and implication of  their assessment and advice provided; 
– be able to discuss the clinical data c ontained within the manufacturer's clinical 
evaluation with the manufact urer and with external clinical experts and to 
appropriately guide external clinical experts in the assessment of the clinical evaluation; 
– be able to scientifically challenge the c linical data presente d, and the results of 
the external clinical experts' assessm ent of the manufacturer's clinical 
evaluation; 
– be able to ascertain the comparabil ity and consistency of the clinical 
assessments conducted by clinical experts;  
EN 132   EN – be able to make an objective clinical  judgement about the assessment of the 
manufacturer's clinical evaluation an d make a recommendation to the notified 
body's decision maker. 
3.2.5.  The personnel responsible for carrying out product related review (e.g. design dossier 
review, technical documentati on review or type examina tion including aspects such 
as clinical evaluation, biological safety, st erilisation, software va lidation) shall have 
the following proven qualification: 
– successful completion of a university or a technical college degree or 
equivalent qualification in relevant st udies, e.g. medicine, natural science or 
engineering;  
– four years professional expe rience in the field of hea lthcare products or related 
sectors (e.g. industry, audit,  healthcare, research e xperience) whilst two years 
of this experience shall be in the de sign, manufacture, testing or use of the 
device or technology to be assessed or re lated to the scientific aspects to be 
assessed; 
– appropriate knowledge of the general safe ty and performance requirements laid 
down in Annex I as well as related delegated and/or implementing acts, 
harmonised standards, CTS and guidance documents; 
– appropriate knowledge and experience of risk management and related medical 
device standards and guidance documents; 
– appropriate knowledge and experience of the conformity assessment 
procedures laid down in Annexes VIII to X, in particular of those aspects for 
which they are authorised, and ade quate authority to carry out those 
assessments. 
3.2.6.  The personnel responsible for carrying out audits of the manufacturer's quality 
management system shall have the following proven qualification: 
– successful completion of a university or a technical college degree or 
equivalent qualification in relevant st udies, e.g. medicine, natural science or 
engineering; 
– four years professional expe rience in the field of hea lthcare products or related 
sectors (e.g. industry, audit,  healthcare, research e xperience) whilst two years 
of this experience shall be in the area of quality management; 
– appropriate knowledge of the medical de vices legislation as well as related 
delegated and/or implemen ting acts, harmonised standards, CTS and guidance 
documents; 
– appropriate knowledge and experience of risk management and related medical 
device standards and guidance documents; 
– appropriate knowledge of quality manage ment systems and related standards 
and guidance documents   
EN 133   EN – appropriate knowledge and experience of the conformity assessment 
procedures laid down in Annexes VIII to X, in particular of those aspects for 
which they are authorised, and adequate  authority to carry out the audits; 
– training in auditing techniques enabling th em to challenge quality management 
systems. 
3.3. Documentation of qualification, traini ng and authorisation of personnel  
3.3.1.  The notified body shall have a process in pl ace to fully document the qualification of 
each personnel involved in conformity asse ssment activities and the satisfaction of 
the qualification criteria referred to in Section 3.2. Where in exceptional 
circumstances the fulfilment of the qualifica tion criteria set out in Section 3.2 cannot 
be fully demonstrated, the notified body shal l appropriately  justify the authorisation 
of these personnel to carry out specific  conformity assessment activities.  
3.3.2.  For its personnel referred to in Sec tions 3.2.3 to 3.2.6, th e notified body shall 
establish and maintain up to date: 
– a matrix detailing the re sponsibilities of the pers onnel in respect of the 
conformity assessment activities;  
– records demonstrating the required  knowledge and experience for the 
conformity assessment activity for which they are authorised.  
3.4. Subcontractors and external experts  
3.4.1.  Without prejudice to the limitations eman ating from Section 3.2., notified bodies 
may subcontract clearly defined parts of the conformity assessment activities. The 
subcontracting of the auditing of quality management systems or of product related 
reviews as a whole is not allowed. 
3.4.2.  Where a notified body subcontracts conformity  assessment activitie s either to an 
organisation or an individual, it shall ha ve a policy describi ng the conditions under 
which subcontracting may take place. Any s ubcontracting or consu ltation of external 
experts shall be properly documented and be  subject to a written agreement covering, 
among others, confidentiality and conflict of interests. 
3.4.3.  Where subcontractors or extern al experts are used in the context of the conformity 
assessment, in particular regarding novel,  invasive and implantable medical devices 
or technologies, the notified body shall have adequate own competence in each product area for which it is de signated to lead the conform ity assessment, to verify 
the appropriateness and validity of expe rt opinions and make the decision on the 
certification. 
3.4.4.  The notified body shall establish proce dures for assessing and monitoring the 
competence of all subcontractors  and external experts used. 
3.5. Monitoring of competences and training  
3.5.1.  The notified body shall appropriately monito r the satisfactory performance of the 
conformity assessment activ ities by its personnel.   
EN 134   EN 3.5.2.  It shall review the competence of its pers onnel and identify traini ng needs in order to 
maintain the required level of qualification and knowledge.  
4. PROCESS REQUIREMENTS  
4.1. The notified body's decision-making process shall be clearly doc umented, including 
the process for the issue, suspension, rein statement, withdrawal or refusal of 
conformity assessment certificates, their modi fication or restriction and the issue of 
supplements. 
4.2. The notified body shall have in place a documented process for the conduct of the 
conformity assessment procedures for which it is designated taking into account their 
respective specificities, including legally re quired consultations, in respect of the 
different categories of devices covered by the scope of notification, ensuring 
transparency and the ability of reproduction of those procedures. 
4.3. The notified body shall have in place docum ented procedures covering at least:  
– the application for conformity asse ssment by a manufacturer or by an 
authorised representative, 
– the processing of the app lication, including the verifi cation of the completeness 
of the documentation, th e qualification of the product as device and its 
classification, 
– the language of the application, of  the correspondence and of the 
documentation to be submitted,  
– the terms of the agreement with the manu facturer or authorised representative, 
– the fees to be charged for conformity assessment activities,  
– the assessment of relevant changes to be submitted for prior approval,  
– the planning of surveillance,  
– the renewal of certificates.   
EN 135   EN ANNEX VII 
CLASSIFICATION  CRITERIA  
I. SPECIFIC DEFINITIONS FOR THE CLASSIFICATION RULES  
1. DURATION OF USE  
1.1. ‘Transient’ means normally intended for c ontinuous use for less than 60 minutes. 
1.2. ‘Short term’ means normally intended fo r continuous use for between 60 minutes 
and 30 days. 
1.3. ‘Long term’ means normally intended for continuous use for more than 30 days. 
2. INVASIVE AND ACTIVE DEVICES  
2.1. ‘Body orifice’ means any natural opening in  the body, as well as the external surface 
of the eyeball, or any permanent artific ial opening, such as a stoma or permanent 
tracheotomy. 
2.2. ‘Surgically invasive device’ means  
(a) an invasive device which penetrates in side the body through the surface of the 
body, with the aid or in the cont ext of a surgical operation; 
(b) a device which produces penetration other than through a body orifice. 
2.3. ‘Reusable surgical instrument’ means an instrument intended for surgical use by 
cutting, drilling, sawing, sc ratching, scraping, clampi ng, retracting, clipping or 
similar procedures, without connection to  any active medical device and which are 
intended by the manufacturer to be reused after appropriate procedures for cleaning 
and/or sterilization ha ve been carried out. 
2.4. ‘Active therapeutic device’ means any active medical device, whether used alone or 
in combination with other medical devices , to support, modify, replace or restore 
biological functions or structures with a view to treatment or alleviation of an illness, injury or disability. 
2.5. ‘Active device intended for diagnosis’ means any active medical device, whether 
used alone or in combination with other medical devices, to supply information for 
detecting, diagnosing, monitoring or treat ing physiological conditions, states of 
health, illnesses or congenital deformities. 
2.6. ‘Central circulatory system’ means the fo llowing blood vessels: arteriae pulmonales, 
aorta ascendens, arcus aorta, aorta descende ns to the bifurcatio aortae, arteriae 
coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna,  
EN 136   EN arteriae cerebrales, truncus brachiocephalic us, venae cordis, venae pulmonales, vena 
cava superior, vena cava inferior. 
2.7. ‘Central nervous system’ means the brain, meninges and spinal cord.  
II. Implementing rules for the classification rules  
1. Application of the classification rules sha ll be governed by the intended purpose of 
the devices. 
2. If the device is intended to be used in combination with another device, the 
classification rules shall apply separately to each of the devices. Accessories are 
classified in their own right separately from the device with which they are used. 
3. Stand alone software, which drives a device or influences the us e of a device, falls 
automatically in the same class as the devi ce. If stand alone soft ware is independent 
of any other device, it is clas sified in its own right.  
4. If the device is not intended to be used solely or principally in a specific part of the 
body, it shall be considered and classified on the basis of the most critical specified 
use. 
5. If several rules, or within the same rule several sub-rules, apply to the same device 
based on the device’s intended purpose, the stri ctest rule and/or sub-rule resulting in 
the higher classification shall apply. 
6. In calculating the dura tion referred to in Chapter I, S ection 1 continuous use means:  
(a) The entire duration of use of the same  device without regard to temporary 
interruption of use during a procedure or temporary removal for purposes such 
as cleaning or disinfection of the device.  Whether the interruption of use or the 
removal is temporary shall be establishe d in relation to the duration of the use 
prior and after the period when the use is interrupted or the device removed.  
(b) The accumulated use of a device that is intended by the manufacturer to be 
replaced immediately with another of the same type. 
7. A device is considered to allow direct dia gnosis when it provides the diagnosis of the 
disease or condition by itself or when it provides decisive information for the 
diagnosis.  
III. Classification rules  
3. NON-INVASIVE DEVICES  
3.1. Rule 1 
All non-invasive devices are in class I, unl ess one of the rules set out hereinafter 
applies.  
EN 137   EN 3.2. Rule 2 
All non-invasive devices intended for cha nnelling or storing blood, body liquids or 
tissues, liquids or gases for the purpose of eventual infusion, administration or 
introduction into the body are in class IIa: 
– if they may be connected to an active medical device in cl ass IIa or a higher 
class, 
– if they are intended for use for stor ing or channelling blood or other body 
liquids or for storing organs, pa rts of organs or body tissues. 
In all other cases they are in class I. 
3.3. Rule 3 
All non-invasive devices intended for m odifying the biological or chemical 
composition of human tissues or cells, bl ood, other body liquids  or other liquids 
intended for implantation or infusion in to the body are in class IIb, unless the 
treatment consists of filtra tion, centrifugation or exchange s of gas, heat, in which 
case they are in class IIa. 
All non-invasive devices intended to be us ed for in vitro fertilisation (IVF) or 
assisted reproduction technologies (ART) whic h are liable to act with close contact 
on the inner or outer cells during the IVF/ART, such as  washing, separating, sperm 
immobilising, cryoprotecting solutions, are in class IIb.  
3.4. Rule 4 
All non-invasive devices which come into contact with injured skin: 
– are in class I if they are intended to be used as a mechanical barrier, for 
compression or for absorption of exudates, 
– are in class IIb if they are intended to  be used principally with wounds which 
have breached the dermis and can  only heal by se condary intent, 
– are in class IIa in all other cases, in cluding devices prin cipally intended to 
manage the micro-environment of a wound. 
4. INVASIVE DEVICES  
4.1. Rule 5 
All invasive devices with respect to body or ifices, other than surgically invasive 
devices and which are not intended for conn ection to an active medical device or 
which are intended for connecti on to an active medical device classified as class I: 
– are in class I if they are intended for transient use,  
EN 138   EN – are in class IIa if they are intended for s hort-term use, except if they are used in 
the oral cavity as far as the pharynx, in an  ear canal up to the ear drum or in a 
nasal cavity, in which case they are in class I, 
– are in class IIb if they are intended for long-term use, except if they are used in 
the oral cavity as far as the pharynx, in an  ear canal up to the ear drum or in a 
nasal cavity and are not liable to be absorbed by the mucous membrane, in 
which case they are in class IIa. 
All invasive devices with respect to body or ifices, other than surgically invasive 
devices, intended for connection to an active medical device in class IIa or a higher 
class, are in class IIa. 
4.2. Rule 6 
All surgically invasive devices intended fo r transient use are in class IIa unless they: 
– are intended to control, diagnose, monitor or correct a defect of the heart or of 
the central circulatory system through di rect contact with these parts of the 
body, in which case they are in class III, 
– are reusable surgical instruments, in which case they are in class I, 
– are intended specifically for use in dire ct contact with the central nervous 
system, in which case they are in class III, 
– are intended to supply energy in the form  of ionising radiation in which case 
they are in class IIb, 
– have a biological effect or are wholly or mainly absorbed in which case they 
are in class IIb, 
– are intended to administer medicines by m eans of a delivery system, if this is 
done in a manner that is potentially h azardous taking account of the mode of 
application, in which case they are in class IIb. 
4.3. Rule 7 
All surgically invasive devices intended fo r short-term use are in class IIa unless 
they: 
– are intended specifically to c ontrol, diagnose, monitor or  correct a defect of the 
heart or of the central circulatory system  through direct contact with these parts 
of the body, in which case they are in class III, 
– are intended specifically for use in dire ct contact with the central nervous 
system, in which case they are in class III, 
– are intended to supply energy in the form  of ionizing radiation in which case 
they are in class IIb,  
EN 139   EN – have a biological effect or are wholly or mainly absorbed in which case they 
are in class III, 
– are intended to undergo chemical change  in the body, except if  the devices are 
placed in the teeth, or to administer medi cines, in which case they are in class 
IIb. 
4.4. Rule 8 
All implantable devices and long-term surgi cally invasive device s are in class IIb 
unless they: 
– are intended to be placed in the teeth,  in which case they are in class IIa, 
– are intended to be used in direct contact  with the heart, th e central circulatory 
system or the central nervous system, in which case they are in class III, 
– have a biological effect or are wholly or mainly absorbed, in which case they 
are in class III, 
– are intended to undergo chemical change  in the body, except if  the devices are 
placed in the teeth, or to administer medi cines, in which case they are in class 
III, 
– are active implantable medical devices or implantable accessories to active 
implantable medical devices, in wh ich case they are in class III, 
– are breast implants, in which case they are in class III, 
– are hip, knee or shoulder total and partial joint replacements, in which case 
they are in class III, with  the exception of an cillary components such as screws, 
wedges, plates and instruments,  
– are spinal disc replacement implants and implantable devices that come into 
contact with the spinal column, in which case they are in class III.  
5. ACTIVE DEVICES  
5.1. Rule 9 
All active therapeutic devices intended to ad minister or exchange energy are in class 
IIa unless their characteristics are such that  they may administer or exchange energy 
to or from the human body in a potential ly hazardous way, taking account of the 
nature, the density and site of  application of the energy, in which case they are in 
class IIb. 
All active devices intended to control or monitor the performance of active 
therapeutic devices in class IIb, or intended directly to influence the performance of such devices are in class IIb.  
EN 140   EN All active devices that are intended fo r controlling, monito ring or directly 
influencing the performance of active implan table medical devices are in class III.  
5.2. Rule 10 
Active devices intended for di agnosis are in class IIa: 
– if they are intended to supply energy which will be  absorbed by the human 
body, except for devices used to illumina te the patient's body, in the visible 
spectrum, 
– if they are intended to image in vivo  distribution of radiopharmaceuticals, 
– if they are intended to allow direct diagnosis or monitoring of vital 
physiological processes, unless they are specifically intende d for monitoring of 
vital physiological parameters, where the nature of  variations is such that it 
could result in immediate danger to th e patient, for instance variations in 
cardiac performance, respiration, activity of central nervous system in which 
case they are in class IIb. 
Active devices intended to em it ionizing radiation and intended for diagnostic or 
therapeutic interventional ra diology including devices which control or monitor such 
devices, or which directly influence their performance, are in class IIb. 
5.3. Rule 11 
All active devices intended to administer and/or remove medici nes, body liquids or 
other substances to or from  the body are in class IIa, unl ess this is done in a manner 
that is potentially h azardous, taking account of the nature  of the substances involved, 
of the part of the body concerned and of th e mode of application in which case they 
are in class IIb. 
5.4. Rule 12 
All other active devices  are in class I. 
6. SPECIAL RULES  
6.1. Rule 13 
All devices incorporating, as an integral part, a substanc e which, if used separately, 
can be considered to be a medicinal produc t, as defined in Article 1 of Directive 
2001/83/EC, including a medicinal product derived from human blood or human 
plasma, with action ancillary to that  of the devices, are in class III. 
6.2. Rule 14 
All devices used for contraception or the prevention of the transmission of sexually 
transmitted diseases are in class IIb, unl ess they are implan table or long term 
invasive devices, in which cas e they are in class III.  
EN 141   EN 6.3. Rule 15 
All devices intended specifically to be us ed for disinfecting, cleaning, rinsing or, 
when appropriate, hydrating cont act lenses are in class IIb. 
All devices intended specifically to be used  for disinfecting or sterilising medical 
devices are in class IIa, unless they are di sinfecting solutions or washer-disinfectors 
intended specifically to be used for disinf ecting invasive devices, as the end point of 
processing, in which case they are in class IIb.  
This rule does not apply to devices that are intended to clean medical devices other 
than contact lenses by mean s of physical action only. 
6.4. Rule 16 
Devices specifically intended for recording of diagnostic images generated by X-ray, 
MRI, ultra-sound or other diagnos tic devices are in class IIa.  
6.5. Rule 17 
All devices manufactured utilising tissues or cells of human or anim al origin, or their 
derivatives, which are non-viab le or rendered non-viable ar e in class III, unless such 
devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viab le or rendered non-viable th at are intended to come 
into contact with intact skin only. 
6.6. Rule 18 
By derogation from other rules,  blood bags are in class IIb. 
6.7. Rule 19 
All devices incorporat ing or consisting of nanomateria l are in class III unless the 
nanomaterial is encapsulated or bound in su ch a manner that it cannot be released 
into the patient’s or user's body when the de vice is used within its intended purpose.  
6.8. Rule 20 
All devices intended to be used for aphaer esis, such as aphaeresis machines, sets, 
connectors and solutions, are in class III. 
6.9. Rule 21 
Devices that are composed of substances or combination of  substances in tended to be 
ingested, inhaled or administ ered rectally or vaginally and that are absorbed by or 
dispersed in the human body are in class III.  
EN 142   EN ANNEX VIII 
CONFORMITY ASSESSMENT BASED ON FULL QUALITY ASSURANCE AND  DESIGN 
EXAMINATION  
Chapter I: Full Qual ity Assurance System  
1. The manufacturer shall ensure applica tion of the quality management system 
approved for the design, manufacture and fina l inspection of the products concerned, 
as specified in Section 3 and is subject to audit as laid  down in Sections 3.3 and 3.4 
and to the surveillance as  specified in Section 4. 
2. The manufacturer who fulfils  the obligations imposed by Section 1 shall draw up and 
keep an EU declaration of conformity in  accordance with Article 17 and Annex III 
for the device model covered by the conformity assessment procedure. By issuing a declaration of conformity the manufacturer  ensures and declares that the devices 
concerned meet the provisions of this  Regulation which apply to them.  
3. Quality management system 
3.1. The manufacturer shall lodge an appl ication for assessment of his quality 
management system with a notified body. The applicati on shall include: 
– the name and address of the manufact urer and any additional manufacturing 
site covered by the quality management  system, and, if th e application is 
lodged by the authorised representative, his name and address as well, 
– all the relevant information on the de vice or device category covered by the 
procedure, 
– a written declaration that no applicat ion has been lodged with any other 
notified body for the same device-rela ted quality management system, or 
information about any previous applica tion for the same device-related quality 
management system that has been refused by another notified body, 
– the documentation on the quality management system, 
– a description of the procedures in place to fulfil the obligations imposed by the 
quality management system approved a nd the undertaking by the manufacturer 
to apply these procedures, 
– a description of the pro cedures in place to k eep the approved quality 
management system adequate and efficacious and the undertaking by the 
manufacturer to apply these procedures, 
– the documentation on the post-market surveillance plan, including, when 
applicable, a plan for the post-market clinical follow-up, and the procedures 
put in place to ensure compliance with the obligations emanating from the provisions on vigilance set out in Articles 61 to 66,  
EN 143   EN – a description of the proce dures in place to keep up to date the post-market 
surveillance plan, including, when appl icable, a plan for the post-market 
clinical follow-up, and the proce dures ensuring compliance with the 
obligations emanating from the provisions  on vigilance set out in Articles 61 to 
66 as well as the undertaking by the manu facturer to apply these procedures. 
3.2. Application of the quality management system  shall ensure that the devices conform 
to the provisions of this Regulation which a pply to them at every stage, from design 
to final inspection. All the elements, re quirements and provisi ons adopted by the 
manufacturer for his quality management system shall be documented in a systematic and orderly manner in the form of written policies and procedures such as quality 
programmes, quality plans, quality  manuals and quality records. 
Moreover, the documentation to be subm itted for the assessment of the quality 
management system shall include an ad equate description of, in particular: 
(a) the manufacturer’s quality objectives; 
(b) the organisation of the bu siness and in particular: 
– the organisational structur es, the responsibilities of  the managerial staff 
and their organisational authority  where quality of design and 
manufacture of the pr oducts is concerned, 
– the methods of monitoring the effi cient operation of the quality 
management system and in particular  its ability to achieve the desired 
quality of design and of  product, including contro l of products which fail 
to conform, 
– where the design, manufacture and/or fi nal inspection and testing of the 
products, or elements thereof, is carried out by another party, the methods of monitoring the efficient operation of the quality management 
system and in particular the type a nd extent of control applied to the 
other party, 
– where the manufacturer does not have a registered place of business in a 
Member State, the draft mandate for the designation of an authorised representative and a letter of intenti on of the authorised representative to 
accept the mandate;  
(c) the procedures and techniques for mon itoring, verifying, validating and 
controlling the design of the devices, including the corresponding documentation as well as the data and r ecords arising from those procedures 
and techniques; 
(d) the inspection and quality assurance tec hniques at the manufacturing stage and 
in particular: 
– the processes and procedures which will  be used, particul arly as regards 
sterilisation, purchasing a nd the relevant documents,  
EN 144   EN – the product identification procedures drawn up and kept up to date from 
drawings, specifications or other rele vant documents at every stage of 
manufacture; 
(e) the appropriate tests and trials which will be carried out before, during and 
after manufacture, the frequency with wh ich they will take place, and the test 
equipment used; it shall be possible to tr ace back the calibr ation of the test 
equipment adequately. 
In addition, the manufacturer shall gran t the notified body access to the technical 
documentation referred to in Annex II. 
3.3. Audit 
(a) The notified body shall aud it the quality management system to determine 
whether it meets the requirements referred to in Section 3.2. Unless duly substantiated, it shall presume that quality management systems which satisfy the relevant harmonised standards or CT S conform to the requirements covered 
by the standards or CTS. 
(b) The assessment team shall include at leas t one member with past experience of 
assessments of the technology concer ned. The assessment procedure shall 
include an audit on the manufacturer's  premises and, if appropriate, on the 
premises of the manufacturer's suppliers  and/or subcontractors to inspect the 
manufacturing and other relevant processes. 
(c) Moreover, in the case of devices falling in to class IIa or IIb the audit procedure 
shall include an assessment, on a re presentative basis, of the design 
documentation within the technical documentation as referred to in Annex II of the device(s) concerned. In choosing re presentative sample(s) the notified body 
shall take into account the novelty of the technology, similarities in design, 
technology, manufacturing a nd sterilisation methods, the intended use and the 
results of any previous relevant asse ssments (e.g. with re gard to physical, 
chemical or biological properties) that  have been carried out in accordance 
with this Regulation. Th e notified body shall documen t its rationale for the 
sample(s) taken. 
(d) If the quality management system confor ms to the relevant provisions of this 
Regulation, the notified body shall i ssue an EU full quality assurance 
certificate. The decision shall be notifie d to the manufacturer . It shall contain 
the conclusions of the aud it and a reasoned assessment. 
3.4. The manufacturer shall inform the no tified body which approved the quality 
management system of any plan for substantial changes to the quality management 
system or the product-range covered. The notified body shall assess the changes proposed and verify whether after these cha nges the quality management system still 
meets the requirements referred to in Secti on 3.2. It shall notify the manufacturer of 
its decision which shall contain the c onclusions of the audit and a reasoned 
assessment. The approval of any substant ial change to the quality management 
system or the product-range covered shall ta ke the form of a supplement to the EU 
full quality assurance certificate.  
EN 145   EN 4. Surveillance assessment 
4.1. The aim of surveillance is to ensure that th e manufacturer duly fulfils the obligations 
imposed by the approved quality management system. 
4.2. The manufacturer shall aut horise the notified body to ca rry out all the necessary 
audits, including inspections, and supply it  with all relevant information, in 
particular: 
– the documentation on the quality management system, 
– the documentation on the post-market surveillance plan, including a post-
market clinical follow-up, as well as, if  applicable, any findings resulting from 
the application of the post-market surv eillance plan, including the post-market 
clinical follow-up, and of the provisions  on vigilance set out in Articles 61 to 
66, 
– the data stipulated in th e part of the quality mana gement system relating to 
design, such as the results of analyses, calculations, tests, th e solutions adopted 
regarding the risk-management as referre d to in Section 2 of Annex I , pre-
clinical and clinical evaluation, 
– the data stipulated in th e part of the quality mana gement system relating to 
manufacture, such as inspection reports and test data, calibration data, 
qualification reports of the personnel concerned, etc. 
4.3. The notified body shall periodically, at least once every 12 months, carry out 
appropriate audits and assessments to make  sure that the manufacturer applies the 
approved quality management system and the post-market surveillance plan, and 
shall supply the manufacturer with an assessment report. This shall include 
inspections on the premises  of the manufacturer and,  if appropriate, of the 
manufacturer's suppliers and/or subcontract ors. At the time of such inspections, the 
notified body shall, where nece ssary, carry out or ask for tests in order to check that 
the quality management system is wo rking properly. It shall provide the 
manufacturer with an inspection report and, if  a test has been carried out, with a test 
report. 
4.4. The notified body shall randomly perform una nnounced factory inspections to the 
manufacturer and, if appropriate, of the manufacturer's suppliers and/or 
subcontractors, which may be combined with the periodic surveillance assessment 
referred to in Section 4.3. or be performed in  addition to this surveillance assessment. 
The notified body shall establish a plan fo r the unannounced inspections which must 
not be disclosed to the manufacturer.  
Within the context of such unannounced in spections, the notified body shall check an 
adequate sample from the production or th e manufacturing process to verify that the 
manufactured device is in conformity with  the technical documentation and/or design 
dossier. Prior to the unannounced inspec tion, the notified body shall specify the 
relevant sampling criteria and testing procedure.  
Instead of, or in addition to, the sampli ng from the production, the notified body shall 
take samples of devices from the market to  verify that the manufactured device is in  
EN 146   EN conformity with the technical documenta tion and/or design dossier. Prior to the 
sampling, the notified body shall specify th e relevant sampling criteria and testing 
procedure. 
The notified body shall provide the manufacturer with an  inspection report which 
shall include, if applicable, the result of the sample check. 
4.5. In the case of devices classified as class IIa or class IIb, the surveillance assessment 
shall also include the assessment of the design documentation within the technical documentation of the device(s) concerned on  the basis of further representative 
sample(s) chosen in accordance with the rationale documented by the notified body in accordance with point (c) of Section 3.3.  
In the case of devices classified as clas s III, the surveillance assessment shall also 
include a check of the approved parts and/ or materials that are essential for the 
integrity of the device, including, wher e appropriate, the coherence between the 
quantities of produced or purchased parts and/or materials and the quantities of 
finished products.  
4.6. The notified body shall ensure that the co mposition of the assessment team assures 
experience with the technology concerned, c ontinuous objectivity an d neutrality; this 
shall include a rotation of the members of the assessment team at appropriate 
intervals. As a general rule, a lead auditor shall not lead and attend an audit for more than three consecutive years in re spect to the same manufacturer.  
4.7. If the notified body establishes a divergen ce between the sample taken from the 
production or from the market and the sp ecifications laid down in the technical 
documentation or the approved design, it shal l suspend or withdraw the relevant 
certificate or impose re strictions on it.  
Chapter II: Design dossier examination  
5. Examination of the design of the device, applicable to devices classified as  
class III 
5.1. In addition to the obligations imposed by Section 3, the manufa cturer shall lodge 
with the notified body referred to  in Section 3.1 an applica tion for examination of the 
design dossier relating to the device which he plans to manufacture and which falls 
into the device category covered by the qu ality management system referred to in 
Section 3. 
5.2. The application shall describe the desi gn, manufacture and performances of the 
device in question. It shall include the te chnical documentation as referred to in 
Annex II; where the technical documentation is voluminous and/or held in different 
locations, the manufacturer shall submit a summary technical documentation (STED) and grant access to the full technical documentation upon request. 
5.3. The notified body shall examine the app lication employing staff with proven 
knowledge and experience regarding the technology concerned. The notified body may require the application to be complete d by further tests or  other evidence to 
allow assessment of conformity with the requirements of the Regulation. The  
EN 147   EN notified body shall carry out adequate physical  or laboratory tests in relation to the 
device or request the manufacturer  to carry out such tests.  
The notified body shall provide the manufact urer with an EU design-examination 
report. 
5.4. If the device conforms to the relevant provisions of this Regulation, the notified body 
shall issue an EU design-examination certif icate. The certificate shall contain the 
conclusions of the examination, the condi tions of validity, the data needed for 
identification of the approved design, wh ere appropriate, a description of the 
intended purpose of the device. 
5.5. Changes to the approved design shall receive  further approval from the notified body 
which issued the EU design-examination certificate wherever the changes could 
affect conformity with the general safe ty and performance requirements of the 
Regulation or with the conditions prescrib ed for use of the device. The applicant 
shall inform the notified body which issued the EU design-examination certificate of 
any planned changes to the approved design. The notified body shall examine the 
planned changes, notify the manufacturer of its decision and provide him with a 
supplement to the EU design-examination re port. The approval of any change to the 
approved design shall take the form of a supplement to the EU design-examination 
certificate.  
6. Specific procedures 
6.1. Procedure in the case of devices in corporating a medicinal substance  
(a) Where a device incorporates, as an integral part, a substance which, if used 
separately, may be considered to be a medicinal product within the meaning of 
Article 1 of Directive 20 01/83/EC, including a medici nal product derived from 
human blood or human plasma, with action ancillary to that of the device, the 
quality, safety and usefulne ss of the substance shall be  verified by analogy with 
the methods specified in Anne x I to Directive 2001/83/EC.  
(b) Before issuing an EU design-examinati on certificate, the no tified body shall, 
having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the de vice, seek a scient ific opinion from 
one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC (herei nafter referred to as 'medicinal 
products competent authority') or the Eu ropean Medicines Agency (hereinafter 
referred to as ‘EMA’), acting partic ularly through its Committee on Human 
Medicinal Products in accordance w ith Regulation (EC) No 726/2004, on the 
quality and safety of the substance including the benefit/risk of the incorporation of the substance into the device. Where the device incorporates a 
human blood or plasma derivative or a s ubstance that, if used separately may 
be considered to be a medicinal product falling exclusively within the scope of 
the Annex of Regulation (EC) No 726/ 2004, the notified body shall consult the 
EMA.  
(c) When issuing its opinion, the medicinal products competent authority or the 
EMA shall take into account the manufactur ing process and the data related to  
EN 148   EN the usefulness of incorporat ion of the substance into the device as determined 
by the notified body. 
(d) The opinion of the medicinal products competent authority or the EMA shall 
be drawn up  
– within 150 days after r eceipt of valid documentation if the substance 
subject to the consultation is authorised in accordance with Directive 2001/83/EC; or  
– within 210 days after receipt of va lid documentation in other cases.  
(e) The scientific opinion of the medicina l products competent authority or the 
EMA, and any possible update, shall be included in the doc umentation of the 
notified body concerning the device. The notified body shall give due 
consideration to the views expressed in the scientific opinion when making its decision. The notified body shall not delive r the certificate if  the scientific 
opinion is unfavourable. It shall convey its final decision to the medicinal 
products competent authority concerned or to the EMA. 
(f) Before changes are made with respect to an ancillary substance incorporated in 
a device, in particular related to it s manufacturing proces s, the manufacturer 
shall inform the notified body of the cha nges which shall cons ult the medicinal 
products competent authority  that was involved in th e initial consultation, in 
order to confirm that the quality and safety of the ancillary substance are maintained. The medicinal products compet ent authority shall take into account 
the data related to the usefulness of in corporation of the substance into the 
device as determined by the notified body, in  order to ensure that the changes 
have no negative impact on the established benefit/risk of the addition of the substance in the device. It shall provide its opinion within 30 days after receipt 
of the valid documentation regarding the changes. 
(g) When the medicinal products competent authority that was involved in the 
initial consultation has obtained inform ation on the ancillary substance, which 
could have an impact on the establishe d benefit/risk of the addition of the 
substance in the device, it shall provide th e notified body with advice whether 
this information has an impact on the esta blished benefit/risk of the addition of 
the substance in the device or not. The notified body shall take the updated 
scientific opinion into account in reconsidering its assessment of the 
conformity assessment procedure. 
6.2. Procedure in the case of devices manufac tured utilising tissues or cells of human 
or animal origin, or their derivatives,  that are non-viable or rendered non-
viable 
(a) For devices manufactured utilising tissues or cells of human origin, or their 
derivatives, that are covered by this Regul ation in accordance with point (e) of 
Article 1(2), the notified body shall, prio r to issuing an EU design-examination 
certificate, submit to the competent au thority designated by the Member State 
in accordance with Directive 2004/23/EC (h ereinafter referred to as 'human 
tissues and cells competent authority') in  which it is established a summary of  
EN 149   EN the preliminary conformity assessment  which shall, among others, provide 
information about the non-viability of  the human tissues or cells, their 
donation, procurement and testing and the benefit/risk of the incorporation of 
the human tissues or cells into the device. 
(b) Within 90 days after receipt of valid  documentation, the human tissues and 
cells competent authority may submit comments on aspects related to the 
donation, procurement and testing and/or the benefit/risk of the incorporation 
of the human tissues or cells into the device.  
(c) The notified body shall give due consider ation to any comments received in 
accordance with point (b). It shall c onvey to the human tissues and cells 
competent authority an explanation as re gards this consider ation, including any 
due justification not to follow the co mment received, and its final decision 
regarding the conformity assessment in question. The comments of the human tissues and cells competent authority sh all be included in the documentation of 
the notified body concerning the device.  
7. Batch verification in the case of devi ces incorporating a medicinal substance 
which, if used separately, may be cons idered to be a medicinal product derived 
from human blood or human plasma referred to in Article 1(4) 
Upon completing the manufacture of each batch of devices that incorporate a 
medicinal substance which, if used separately, may be cons idered to be a medicinal 
product derived from human blood or human  plasma referred to in the first 
subparagraph of Article 1(4), the manufactur er shall inform the notified body of the 
release of the batch of devi ces and send to it the official  certificate concerning the 
release of the batch of human blood or plas ma derivative used in the device, issued 
by a State laboratory or a la boratory designated  for that purpose by a Member State 
in accordance with Article 114(2) of Directive 2001/83/EC.  
Chapter III: Administrative provisions  
8. The manufacturer or his aut horised representative shall,  for a period ending at least 
five years, and in the case of implantable devices at least 15 years, after the last 
device has been placed on the market, keep  at the disposal of the competent 
authorities:  
– the declaration of conformity, 
– the documentation referred to in the f ourth indent of Section 3.1 and in 
particular the data and records arising fr om the procedures referred to in point 
(c) of Section 3.2,  
– the changes referred to in Section 3.4, 
– the documentation referred to in Section 5.2, and 
– the decisions and reports from the notifie d body as referred to  in Sections 3.3, 
4.3, 4.4. 5.3, 5.4. and 5.5.   
EN 150   EN 9. Each Member State shall make provision th at this documentation is kept at the 
disposal of the competent authorities for th e period indicated in the first sentence of 
the preceding paragraph in case the manufactur er, or his authorised representative, 
established within its territory goes bankrupt  or ceases its business activity prior to 
the end of this period.  
EN 151   EN ANNEX IX  
CONFORMITY  ASSESSEMENT  BASED  ON  TYPE  EXAMINATION 
1. EU type-examination is the procedure whereby a notified body ascertains and 
certifies that a representative sample of the production covered fulfils the relevant 
provisions of this Regulation. 
2. Application 
The application shall include: 
– the name and address of the manufacture r and, if the application is lodged by 
the authorised representative, the name and address of the authorised representative, 
– the technical documentation referred to in Annex II needed to assess the 
conformity of the representative sa mple of the production in question, 
hereinafter referred to as the ‘type’, with the requirements of this Regulation; where the technical documentation is voluminous and/or held in different locations, the manufacturer shall subm it a summary technical documentation 
(STED) and grant access to the full technical documentation upon request. The applicant shall make a ‘t ype’ available to the notif ied body. The notified body 
may request other samples as necessary,  
– a written declaration that no applicat ion has been lodged with any other 
notified body for the same type, or information about any previous application for the same type that has been refused by another notified body. 
3. Assessment 
The notified body shall: 
3.1. examine and assess the technical documenta tion and verify that the type has been 
manufactured in conformity with that documentation; it shall also record the items designed in conformity with the applicable specifications of the standards referred to 
in Article 6 or CTS , as well as the items not designed on the basis of the relevant 
provisions of the abovementioned standards; 
3.2. carry out or arrange for th e appropriate assessments a nd the physical or laboratory 
tests necessary to verify whether the solu tions adopted by the manufacturer meet the 
general safety and performance requirement s of this Regulation if the standards 
referred to in Article 6 or CTS have not been  applied; if the device is to be connected 
to other device(s) in order to operate as intended, proof shall be provided that it 
conforms to the general safety and perfor mance requirements when connected to any 
such device(s) having the characteri stics specified by the manufacturer; 
3.3. carry out or arrange for th e appropriate assessments a nd the physical or laboratory 
tests necessary to verify whether, if the manufacturer has c hosen to apply the 
relevant standards, these ha ve actually been applied;  
EN 152   EN 3.4. agree with the applicant on the place where the necessary assessments and tests will 
be carried out. 
4. Certificate 
If the type conforms to th e provisions of this Regulati on, the notified body shall issue 
an EU type-examination certificate. The certificate shall contain the name and 
address of the manufacturer, the conclusions  of the assessment, the conditions of 
validity and the data needed for identification of the type approved. The relevant parts of the documentation shall be annexed to the certificate and a copy kept by the notified body. 
5. Changes to the type 
5.1. The applicant shall inform the notified body which issued the EU type-examination 
certificate of any planned cha nge to the approved type.  
5.2. Changes to the approved product shall rece ive further approval from the notified 
body which issued the EU type-examination certificate wherever the changes may 
affect conformity with the general safety and performance requirements or with the conditions prescribed for use of the pr oduct. The notified body shall examine the 
planned changes, notify the manufacturer of its decision and provide him with a 
supplement to the EU type-examination report. The approval of any change to the 
approved type shall take the form of a s upplement to the initial EU type-examination 
certificate.  
6. Specific procedures  
The provisions regarding the specific procedur es in the case of devices incorporating 
a medicinal substance, or devices manufactured  utilising tissues or  cells of human or 
animal origin, or their derivatives, that are non-viable or rendered non-viable set out 
in Annex VIII, Section 6, apply with the pr oviso that any reference to an EU design-
examination certificate shall be understood as  reference to an EU type-examination 
certificate.  
7. Administrative provisions 
The manufacturer or his aut horised representative shall,  for a period ending at least 
five years, and in the case of implantable devices at least 15 years, after the last 
device has been placed on the market, keep  at the disposal of the competent 
authorities: 
– the documentation referred to in the second indent of Section 2, 
– the changes referred to in Section 5,  
– copies of EU type-examination cer tificates and their additions.  
Section 9 of Annex VIII shall apply.  
EN 153   EN ANNEX X  
CONFORMITY  ASSESSEMENT  BASED  ON  PRODUCT  CONFORMITY  
VERIFICATION 
1. The objective of the conformity assessment  based on product conformity verification 
is to ensure that devices conform to th e type for which an EU type-examination 
certificate has been issued and meet the pr ovisions of this Regulation which apply to 
them.  
2. Where an EU type-examination certificate ha s been issued in accordance with Annex 
IX, the manufacturer can either apply the procedure set out in part A (production 
quality assurance) or the procedure set out in part B (product verification).  
3. By way of derogation from Sections 1 a nd 2, this Annex can also be applied by 
manufacturers of devices clas sified as class IIa coupled  with the drawing up of a 
technical documentation as  set out in Annex II.  
PART A: PRODUCTION QUALITY ASSURANCE  
1. The manufacturer shall ensure applica tion of the quality management system 
approved for the manufacture of the devi ces concerned and carry out the final 
inspection, as specified in Section 3, and is  subject to the survei llance referred to in 
Section 4. 
2. The manufacturer who fulfils  the obligations imposed by Section 1 shall draw up and 
keep an EU declaration of conformity in  accordance with Article 17 and Annex III 
for the device model covered by the conform ity assessment procedure. By issuing an 
EU declaration of conformity  the manufacturer ensures and declares that the devices 
concerned conform to the type described in the EU type-examination certificate and 
meet the provisions of this Re gulation which apply to them. 
3. Quality management system 
3.1. The manufacturer shall lodge an appl ication for assessment of his quality 
management system with a notified body. The applicati on shall include: 
– all elements listed in Section 3.1 of Annex VIII,  
– the technical documentation as referred to in Annex II for the types approved; 
where the technical documentation is voluminous and/or held in different locations, the manufacturer shall subm it a summary technical documentation 
(STED) and grant access to the full technical documentation upon request;  
– a copy of the EU-type exam ination certificates referr ed to in Section 4 of 
Annex IX; if the EU-type examination ce rtificates have been issued by the 
same notified body with which the applic ation is lodged, a reference to the 
technical documentation and the certificates issued is sufficient.   
EN 154   EN 3.2. Application of the quality management system  shall ensure that the devices conform 
to the type described in the EU type-exa mination certificate and to the provisions of 
this Regulation which apply to them at ev ery stage. All the elements, requirements 
and provisions adopted by the manufacturer for his quality management system shall 
be documented in a systematic and orderl y manner in the form of written policies 
and procedures such as quality programme s, quality plans, quality manuals and 
quality records. 
It shall, in particular, include an adequate  description of all elements listed in points 
(a), (b), (d) and (e) of Section 3.2 of Annex VIII.  
3.3. The provisions of points (a) and (b) of  Section 3.3 of Annex VIII apply.  
If the quality management system ensures that the devices conform to the type 
described in the EU type-examination cert ificate and conforms  to the relevant 
provisions of this Regulation, the notified body shall issue an EU  quality assurance 
certificate. The decision shall be notified to the manufacturer. It shall contain the 
conclusions of the inspecti on and a reasoned assessment. 
3.4. The provisions of Section 3.4 Annex VIII apply.  
4. Surveillance 
The provisions of Section 4.1, the first, s econd and fourth indents of Section 4.2, 
Section 4.3, Section 4.4, Section 4.6 and Section 4.7 of Annex VIII apply. 
In the case of devices classified as class III, the surveillance shall also include a 
check of the coherence between the quantit y of produced or purchased raw material 
or crucial components approved for the type and the quantity of finished products. 
5. Batch verification in the case of devi ces incorporating a medicinal substance 
which, if used separately, may be cons idered to be a medicinal product derived 
from human blood or human plasma referred to in Article 1(4) 
Upon completing the manufacture of each batch of devices that incorporate a 
medicinal substance which, if used separately, may be cons idered to be a medicinal 
product derived from human blood or human  plasma referred to in the first 
subparagraph of Article 1(4), the manufactur er shall inform the notified body of the 
release of the batch of devi ces and send to it the offici al certificate concerning the 
release of the batch of human blood or plas ma derivative used in the device, issued 
by a State laboratory or a la boratory designated  for that purpose by a Member State 
in accordance with Article 114(2) of Directive 2001/83/EC. 
6. Administrative provisions 
The manufacturer or his aut horised representative shall,  for a period ending at least 
five years, and in the case of implantable devices at least 15 years, after the last 
device has been placed on the market, keep  at the disposal of the competent 
authorities:  
– the declaration of conformity,  
EN 155   EN – the documentation referred to in the fourth  indent of Section 3.1 of Annex VIII,  
– the documentation referred to in the se venth indent of Se ction 3.1 of Annex 
VIII, including the EU type-examination certificate referred to in Annex IX, 
– the changes referred to in S ection 3.4 of Annex VIII, and 
– the decisions and reports from the notifie d body as referred to  in Sections 3.3, 
4.3 and 4.4 of Annex VIII. 
Section 9 of Annex VIII shall apply. 
7. Application to devices classified as class IIa 
7.1. By way of derogation from Sec tion 2, by virtue of the EU declaration of conformity 
the manufacturer ensures and declares that the devices in class IIa are manufactured 
in conformity with the technical documenta tion referred to in Annex II and meet the 
requirements of this Regulat ion which apply to them. 
7.2. For devices in class IIa the notified body shall assess, as part of the assessment in 
Section 3.3, on a representative basis, th e technical documentation as referred in 
Annex II for compliance with the provisions of this Regul ation; where the technical 
documentation is voluminous and/or held in different locations, the manufacturer shall submit a summary technical document ation (STED) and grant access to the full 
technical documentation upon request.  
In choosing representative sa mple(s) the notified body shal l take into account the 
novelty of the technology, similarities in design, technology, manufacturing and 
sterilisation methods, the intended use and the results of any previous relevant 
assessments (e.g. with regard to  physical, chemical or biolog ical properties) that have 
been carried out in accordance with this Regulation. The notified body shall document its rationale for the sample(s) taken. 
7.3. If the assessment in accordance with Secti on 7.2. confirms that the devices in class 
IIa conform to the technical documentati on referred to in Annex II and meet the 
requirements of this Regulation which appl y to them, the notified body shall issue a 
certificate pursuant to this  section of this Annex.  
7.4. Further samples shall be assessed by the notified body as part of the surveillance 
assessment referred to in Section 4. 
7.5. By way of derogation from Section 6, the manufacturer or his authorised 
representative shall, for a pe riod ending at least five year s after the last device has 
been placed on the market, keep at the di sposal of the competent authorities:  
– the declaration of conformity, 
– the technical documentation referred to in Annex II, 
– the certificate referred  to in Section 7.3. 
Section 9 of Annex VIII shall apply.  
EN 156   EN PART B: PRODUCT VERIFICATION  
1. Product verification is the procedure whereby after examination of every 
manufactured device the manuf acturer, by issuing a EU decl aration of conformity in 
accordance with Article 17 and Annex III, ensures and declares that the devices which have been subject to the procedure se t out in Sections 4 and 5 conform to the 
type described in the EU type-examinati on certificate and meet the requirements of 
this Regulation which apply to them. 
2. The manufacturer shall take all the meas ures necessary to ensure that the 
manufacturing process produces devices whic h conform to the type described in the 
EU type-examination certificate and to the requirements of the Regulation which apply to them. Before the start of manufacture, the manufacturer shall prepare 
documents defining the manufacturing process,  in particular as regards sterilisation 
where necessary, together with all the rou tine, pre-established provisions to be 
implemented to ensure homogeneous production and, where appropriate, conformity of the products with the t ype described in the EU type -examination certificate and 
with the requirements of this Regulation which apply to them.  
In addition, for devices placed on the market in sterile condition, and only for those 
aspects of the manufacturing process designe d to secure and maintain sterility, the 
manufacturer shall apply the provisions of Sections 3 and 4 of Part A of this Annex. 
3. The manufacturer shall undertake to institu te and keep up to date a post-market 
surveillance plan, including a post-market  clinical follow-up, and the procedures 
ensuring compliance with the obligations em anating from the provisions on vigilance 
set out in Articles 61 to 66.  
4. The notified body shall carry out the appropria te examinations and tests in order to 
verify the conformity of the device w ith the requirements of the Regulation by 
examining and testing every produc t as specified in Section 5. 
The aforementioned checks do not apply to  those aspects of the manufacturing 
process designed to secure sterility. 
5. Verification by examination and testing of every product 
5.1. Every device is examined individually a nd the appropriate physic al or laboratory 
tests defined in the relevant standard(s) referred to in Article 6 or equivalent tests 
shall be carried out in orde r to verify, where appropria te, the conformity of the 
devices with the type descri bed in the EU type-examinati on certificate and with the 
requirements of this Regulat ion which apply to them. 
5.2. The notified body shall affix, or have affi xed its identification number to each 
approved device and shall draw up an EU product verification cer tificate relating to 
the tests carried out. 
6. Batch verification in the case of devi ces incorporating a medicinal substance 
which, if used separately, may be cons idered to be a medicinal product derived 
from human blood or human plasma referred to in Article 1(4)  
EN 157   EN Upon completing the manufacture of each batch of devices that incorporate a 
medicinal substance which, if used separately, may be cons idered to be a medicinal 
product derived from human blood or human  plasma referred to in the first 
subparagraph of Article 1(4), the manufactur er shall inform the notified body of the 
release of the batch of devi ces and send to it the official  certificate concerning the 
release of the batch of human blood or plas ma derivative used in the device, issued 
by a State laboratory or a la boratory designated  for that purpose by a Member State 
in accordance with Article 114(2) of Directive 2001/83/EC. 
7. Administrative provisions 
The manufacturer or his aut horised representative shall,  for a period ending at least 
five years, and in the case of implantable devices at least 15 years, after the last 
device has been placed on the market, keep  at the disposal of the competent 
authorities:  
– the declaration of conformity, 
– the documentation referred to in Section 2, 
– the certificate referred  to in Section 5.2, 
– the EU type-examination certifi cate referred to in Annex IX. 
Section 9 of Annex VIII shall apply. 
8. Application to devices classified as class IIa 
8.1. By way of derogation from Sec tion 1, by virtue of the EU declaration of conformity 
the manufacturer ensures and declares that the devices in class IIa are manufactured 
in conformity with the technical documenta tion referred to in Annex II and meet the 
requirements of this Regulat ion which apply to them. 
8.2. The verification conducted by the notifie d body in accordance with Section 4 is 
intended to confirm the conformity of the devices in class IIa with the technical 
documentation referred to in Annex II and with the requirements of this Regulation 
which apply to them. 
8.3. If the verification in accordance with Secti on 8.2. confirms that the devices in class 
IIa conform to the technical documentati on referred to in Annex II and meet the 
requirements of this Regulation which appl y to them, the notified body shall issue a 
certificate pursuant to this  section of this Annex. 
8.4. By way of derogation from Section 7, the manufacturer or his authorised 
representative shall, for a pe riod ending at least five year s after the last device has 
been placed on the market, keep at the di sposal of the competent authorities:  
– the declaration of conformity, 
– the technical documentation referred to in Annex II,  
EN 158   EN – the certificate referred  to in Section 8.3. 
Section 9 of Annex VIII shall apply.  
EN 159   EN ANNEX XI 
CONFORMITY ASSESSMENT PROCEDURE FOR CUSTOM -MADE DEVICES  
1. For custom-made devices the manufacturer or his authorised representative shall 
draw up the statement containi ng the following information: 
– the name and address of the manufacturer, and of any additional manufacturing 
sites, 
– if applicable, the name and address of the authorised representative,  
– data allowing identification of the device in question, 
– a statement that the device is intended fo r exclusive use by a particular patient 
or user, identified by name, an  acronym or a numerical code, 
– the name of the doctor of medicine, de ntal practitioner or  any other person 
authorised by national law by virtue of this person's professional qualifications 
who made out the prescription and, where applicable, the name of the health institution concerned, 
– the specific characteristics of the pr oduct as indicated by the prescription, 
– a statement that the device in question conforms to the general safety and 
performance requirements set out in A nnex I and, where applicable, indicating 
which general safety and performance re quirements have not been fully met, 
together with the grounds, 
– where applicable, an indication that th e device contains or incorporates a 
medicinal substance, includi ng a human blood or plasma  derivative, or tissues 
or cells of human origin, or of animal origin as referred to in Commission 
Regulation (EU) No 722/2012. 
2. The manufacturer shall undertake to keep  available for the competent national 
authorities the documentation, indicating manufacturing site(s) and allowing an 
understanding of the design, manufacture and performances of the product, including 
the expected performances, so as to a llow assessment of conformity with the 
requirements of this Regulation. 
The manufacturer shall take all the meas ures necessary to ensure that the 
manufacturing process produces products which are manufactured in accordance 
with the documentation mentione d in the first paragraph; 
3. The information contained in the declaratio n concerned by this Annex shall be kept 
for a period of time of at least five years after the de vice has been placed on the 
market. In the case of implantable devices the period shall be at least 15 years. 
Section 9 of Annex VIII shall apply.  
EN 160   EN 4. The manufacturer shall undertak e to review and document experience gained in the 
post-production phase, including a PMCF referre d to in Part B of Annex XIII, and to 
implement appropriate means to apply any necessary corrective action. This 
undertaking shall include an obligation for the manufacturer to notify, in accordance 
with Article 61(4) the competent authoritie s of any serious inci dents and/or field 
safety corrective actions imme diately on learning of them.  
EN 161   EN ANNEX XII  
MINIMUM  CONTENT  OF CERTIFICATES  ISSUED  BY A NOTIFIED  
BODY 
1. Name, address and identificati on number of the notified body; 
2. name and address of the manufacturer an d, if applicable, of the authorised 
representative; 
3. unique number identifyi ng the certificate; 
4. date of issue;  
5. date of expiry;  
6. data needed for the identification of the de vice(s) or categories of  devices covered by 
the certificate, including the intended purpose of the device(s) and the GMDN code(s) or internationally rec ognised nomenclature code(s); 
7. if applicable, the manufacturing facilities covered by the certificate; 
8. reference to this Regulation and the relevant Annex according to which the 
conformity assessment has been carried out; 
9. examinations and tests performed, e.g. referen ce to relevant standards / test reports / 
audit report(s); 
10. if applicable, reference to the relevant parts of the t echnical documentation or other 
certificates required for the placing on the market of the device(s) covered; 
11. if applicable, information about th e surveillance by th e notified body;  
12. conclusions of the notified body’s assessm ent, examination or inspection;  
13. conditions for or limitations to the validity of the certificate; 
14. legally binding signature of the notified body according to the applicable national 
law.  
EN 162   EN ANNEX XIII 
CLINICAL  EVALUATION  AND  POST-MARKET  CLINICAL   
FOLLOW-UP 
PART A: CLINICAL EVALUATION  
1. To conduct a clinical evalua tion, a manufacturer shall: 
– identify the general safety and perfor mance requirements that require support 
from relevant clinical data; 
– identify available clinical data relevant to the device and its intended use 
generated through scientific literature sear ch, clinical experience and/or clinical 
investigations;  
– appraise the clinical data sets by evalua ting their suitability for establishing the 
safety and performance of the device; 
– generate any new or additional clinical  data needed to address outstanding 
issues; 
– analyse all relevant clinical data to reach conclusions about the safety and 
performance of the device. 
2. Confirmation of conformity with the requirements concerning the characteristics and 
performances referred to in Section 1 of Annex I, under the normal conditions of use 
of the device, and the evaluation of the undesirable side-effects and of the 
acceptability of the benefit/risk  ratio referred to in Sections  1 and 5 of Annex I, shall 
be based on clinical data.  
3. The clinical evaluation shall be thorough a nd objective, considering both favourable 
and unfavourable data. Its depth and extent shall be proportionate and appropriate to 
the nature, classification, inte nded use, manufacturer’s clai ms and risks of the device 
in question.  
4. Clinical data relating to another device may be relevant where equivalence is 
demonstrated of the device subject to clin ical evaluation to the device to which the 
data relates. Equivalence can only be demons trated when the device that is subject to 
clinical evaluation and the device to which th e existing clinical data relates have the 
same intended purpose and wh en the technical and biological characteristics of the 
devices and the medical procedures applied ar e similar to such an extent that there 
would be not a clinically si gnificant difference in the safe ty and performance of the 
devices.  
5. In the case of implantable devices and devices falling within class III, clinical 
investigations shall be perfor med unless it is duly justified to rely on existing clinical 
data alone. Demonstration of equivalen ce in accordance with Section 4 shall  
EN 163   EN generally not be considered as  sufficient justification with in the meaning of the first 
sentence of this paragraph. 
6. The results of the clinical evaluation and the clinical data on which it is based shall 
be documented in the clinical evaluation re port which shall suppor t the assessment of 
the conformity of the device.  
The clinical data together with non-clinical data genera ted from non-clinical testing 
methods and other relevant documentati on shall allow the manufacturer to 
demonstrate conformity with the general safety and performance requirements and shall be part of the technical docu mentation of the device in question.  
P
ART B: POST-MARKET CLINICAL FOLLOW -UP  
1. Post-market clinical follow- up, hereinafter: PMCF, is a continuous process to update 
the clinical evaluation referred to in Article  49 and Part A of this Annex and shall be 
part of the manufacturer's post-market  surveillance plan. To this end, the 
manufacturer shall proactively collect and eval uate clinical data from the use in or on 
humans of a device which is authorised to  bear the CE marking, within its intended 
purpose as referred to in the relevant conf ormity assessment procedure, with the aim 
of confirming the safety and performan ce throughout the expect ed lifetime of the 
device, the continued acceptability of identi fied risks and to detect emerging risks on 
the basis of factual evidence.  
2. The PMCF shall be performed pursuant to a documented method laid down in a 
PMCF plan.  
2.1. The PMCF plan shall specify the methods a nd procedures to proactively collect and 
evaluate clinical data  with the aim of  
(a) confirming the safety and performance of the device throug hout its expected 
lifetime, 
(b) identifying previously u nknown side-effects and monito ring the identified side-
effects and contra-indications,  
(c) identifying and analysing emergent risk s on the basis of factual evidence,  
(d) assuring the continued acceptability of the benefit/risk ratio referred to in 
Sections 1 and 5 of Annex I, and 
(e) identifying possible systematic misuse or  off-label use of the device with a 
view to verify the correctness of its intended purpose. 
2.2. The PMCF plan shall lay down, in particular  
(a) the general methods and procedures of  the PMCF to be applied, such as 
gathering of clinical experience gaine d, feedback from users, screening of 
scientific literature and of other sources of clinical data;   
EN 164   EN (b) the specific methods and procedures of PM CF to be applied, such as evaluation 
of suitable registers or PMCF studies;  
(c) a rationale for the appropriateness of th e methods and procedures referred to in 
points (a) and (b);  
(d) a reference to the relevant parts of the clinical evaluation report referred to in 
Section 6 of Part A of this Annex and to  the risk management referred to in 
Section 2 of Annex I; 
(e) the specific objectives to be addressed by the PMCF;  
(f) an evaluation of the clini cal data related to equivalent or similar devices, 
(g) reference to relevant stan dards and guidance on PMCF.  
3. The manufacturer shall analys e the findings of the PMCF and document the results in 
a PMCF evaluation report th at shall be part of the technical documentation. 
4. The conclusions of the PMCF evaluation report shall be taken into ac count for the 
clinical evaluation referred to in Article 49 and Part A of this Annex and in the risk 
management referred to in Section 2 of Annex I. If through the PMCF the need for corrective measures has been identified, the manufacturer shall implement them.  
EN 165   EN ANNEX XIV  
CLINICAL  INVESTIGATIONS 
I. General requirements 
1. Ethical considerations 
Every step in the clinical investigation, from first cons ideration of the need and 
justification of the study to the publication of the results, sha ll be carried out in 
accordance with recognised ethical principles , as for example those laid down in the 
World Medical Association Declaration of He lsinki on Ethical Principles for Medical 
Research Involving Human Subjects, adopted by the 18th World Medical 
Association General Assembly in Helsinki , Finland, in 1964, and last amended by 
the 59th World Medical Association Gene ral Assembly in Seoul, Korea, in 2008. 
2. Methods 
2.1. Clinical investigations shall be performed on the basis of an appropriate plan of 
investigation reflecting the latest scientif ic and technical know ledge and defined in 
such a way as to confirm or refute the manufacturer's claims for the device as well as the safety, performance and benefit/risk rela ted aspects referred to  in Article 50(1); 
these investigations shall include an adequa te number of observations to guarantee 
the scientific validity of the conclusions. 
2.2. The procedures used to perform the investig ations shall be appropr iate to the device 
under examination. 
2.3. Clinical investigations shall be performe d in circumstances similar to the normal 
conditions of use of the device. 
2.4. All the appropriate features, including thos e involving the safety and performances 
of the device, and its effect on patients shall be examined. 
2.5. The investigations shall be performed under the responsibility of a medical 
practitioner or another author ised qualified person in an  appropriate environment. 
2.6. The medical practitioner or other authorised  person shall have access to the technical 
and clinical data regarding the device. 
2.7. The clinical investigation report, signe d by the medical practitioner or other 
authorised person responsible, shall contai n a critical evaluation of all the data 
collected during the clinical inve stigation, including negative findings. 
II. Documentation regarding the app lication for clinical investigation 
For investigational devices c overed by Article 50 the sponsor shall draw up and submit the 
application in accordance with Article 51 accompanied by the documentation as laid down 
below:  
1. Application form  
EN 166   EN The application form shall be duly filled  in, containing information regarding:  
1.1. Name, address and contact details of the sponsor and, if applicable, name, address 
and contact details of his contac t person established in the Union. 
1.2. If different from the Section 1.1., name , address and contact details of the 
manufacturer of the device in tended for clinical  investigation and, if applicable, of 
his authorised representative. 
1.3. Title of the clini cal investigation.  
1.4. Single identification number in accordance with Article 51(1). 
1.5. Status of the clinical in vestigation (e.g. first submi ssion, resubmission, significant 
amendment). 
1.6. If resubmission with regard to same devi ce, previous date(s) and reference number(s) 
of earlier submission(s) or in the case of  significant amendment, reference to the 
original submission. 
1.7. If parallel submission for a clinical tria l on a medicinal product in accordance with 
Regulation (EU) No […/…] [on clinical tr ials on medicinal products for human use], 
reference to the official registrati on number of the clinical trial.  
1.8. Identification of the Member States, EFTA countries, Turkey and third countries in 
which the clinical investigation shall be conducted as part of a 
multicentre/multinational study at  the time of application.  
1.9. Brief description of the investigati onal device (e.g. name, GMDN code or 
internationally recognised nomenclature code, intended purpose, risk class and 
applicable classification rule according to Annex VII). 
1.10. Information as to whether the device inco rporates a medicinal substance, including a 
human blood or plasma derivative, or whethe r it is manufactured utilising non-viable 
tissues or cells of human or animal  origin, or their derivatives.  
1.11. Summary of the clinical investigation plan ( objective(s) of the clinical investigation, 
number and gender of subjects, criteria for subject selection, subjects under 18 years 
of age, design of the investigation such as controlled and/or randomised studies, 
planned dates of commencement and of comp letion of the clinical investigation).  
1.12. If applicable, information regarding a comparator (e.g. identification of the 
comparator device or medicinal product).  
2. Investigator’s Brochure  
The investigator's brochure (IB) shall contain the clinical and non-clinical 
information on the investigational device th at is relevant for the investigation and 
available at the time of application. It shall be clearly iden tified and contain in 
particular the following information:   
EN 167   EN 2.1. Identification and description of the devi ce, including information on the intended 
purpose, the risk classification and applicab le classification rule  according to Annex 
VII, design and manufacturing of the device and reference to previous and similar 
generations of the device. 
2.2. Manufacturer's instructions for installati on, and use, including storage and handling 
requirements, as well as the label and instru ctions for use to the extent that this 
information is available. 
2.3. Pre-clinical testing and experimental da ta, in particular regarding in design 
calculations, in vitro  tests, ex vivo  tests, animal tests, mechan ical or electrical tests, 
reliability tests, software verification and validation, performance tests, evaluation of 
biocompatibility and biological safety.  
2.4. Existing clinical data, in particular  
– of the relevant scientific literature ava ilable relating to the safety, performance, 
design characteristics and intended purpos e of the device and/ or of equivalent 
or similar devices; 
– of other relevant clinical data availa ble relating to the safety, performance, 
design characteristics and intended purpose of equivalent or similar devices of 
the same manufacturer, including length of  time on the market and a review of 
performance and safety related issues  and any corrective actions taken; 
2.5. Summary of the risk/benefit analysis and the risk management, including information 
regarding known or foreseeable risks, any undesirable effects, contra-indications and 
warnings. 
2.6. In the case of devices that incorporates  a medicinal substance, including a human 
blood or plasma derivative, or devices ma nufactured utilising non- viable tissues or 
cells of human or animal origin, or thei r derivatives, detailed information on the 
medicinal substance or on the tissues or cells, and on the compliance with the relevant general safety and performance requirements and the specific risk management in relation to the substance or tissues or cells.  
2.7. Reference to harmonised or other internat ionally recognised standards complied with 
in full or in part.  
2.8. A clause that any updates to the IB or any other relevant  information that is newly 
available shall be brought to the attention of the investigators. 
3. Clinical Investigation Plan 
The clinical investigation plan (CIP) sha ll define the rationale, objectives, design and 
proposed analysis, methodology, monitoring,  conduct and record-keeping of the 
clinical investigation. It sh all contain in particular th e information as laid down 
below. If part of this information is submitted in a separate document, it shall be referenced in the CIP.  
3.1. General   
EN 168   EN 3.1.1.  Identification of the clinical  investigation and the CIP. 
3.1.2.  Identification of the sponsor. 
3.1.3.  Information on the principal investigator, coordinating investig ator, including their 
qualifications, and on the investigation site(s).  
3.1.4.  Overall synopsis of the clinical investigation. 
3.2. Identification and description of the devi ce, including its intended purpose, its 
manufacturer, its traceabili ty, the target population, ma terials coming into contact 
with the human body, the medical  or surgical procedures involved in its use and the 
necessary training and e xperience for its use.  
3.3. Justification for the design of  the clinical investigation. 
3.4. Risks and benefits of the device a nd of the clinical investigation. 
3.5. Objectives and hypotheses of th e clinical investigation.  
3.6. Design of the clinical investigation  
3.6.1.  General information such as type of i nvestigation with rationale for choice, 
endpoints, variables. 
3.6.2.  Information on the device to be used for th e clinical investigati on, on any comparator 
and on any other device or medication.  
3.6.3.  Information on subjects, incl uding size of investigation population and, if applicable, 
information on vulnerable populations.  
3.6.4.  Description of the procedures rela ted to the clini cal investigation. 
3.6.5.  Monitoring plan. 
3.7. Statistical considerations. 
3.8. Data management. 
3.9. Information about any amendments to the CIP. 
3.10. Policy regarding deviations from the CIP. 
3.11. Accountability regarding the device, in part icular control of ac cess to the device, 
follow-up in relation to the device used in th e clinical investigation and the return of 
unused, expired or malfunctioning devices. 
3.12. Statement of compliance with the recognised ethical principles for medical research 
involving humans and the principles of good cl inical practice in the field of clinical 
investigations of medical devices as well as with the applicable regulatory 
requirements. 
3.13. Informed consent process.  
EN 169   EN 3.14. Safety reporting, including definitions of a dverse events and serious adverse events, 
procedures and timelines for reporting.  
3.15. Criteria and procedures for suspension or  early termination of the clinical 
investigation. 
3.16. Policy as regards the establishment of the clinical investigation report and 
publication of results in accordance with the legal requirements and the ethical 
principles referred to in Section 1 of Chapter I. 
3.17. Bibliography. 
4. Other information 
4.1. A signed statement by the natural or legal pe rson responsible for the manufacture of 
the investigational device that the device in question conforms to the general safety and performance requirements apart from  the aspects covere d by the clinical 
investigation and that, with regard to th ese aspects, every precaution has been taken 
to protect the health and safety of the subject.  
This statement may be supported by an attestation issued  by a notified body. 
4.2. Where applicable according to national la w, copy of the opinion(s) of the ethics 
committee(s) concerned as soon as available. 
4.3. Proof of insurance cover or indemnification of subjects in case of injury, according 
to the national law. 
4.4. Documents and procedures to be used to obtain informed consent. 
4.5. Description of the arrangemen ts to comply with the appl icable rules on the protection 
and confidentiality of personal data, in particular: 
– organisational and technical arrangements that will be implemented to avoid 
unauthorised access, disclosure, dissemination, alteration or loss of information and personal data processed; 
– a description of measures that will be implemented to ensure confidentiality of 
records and personal data of subjects c oncerned in clinical investigations; 
– a description of measures that will be implemented in case of data security 
breach in order to mitigate the possible adverse effects. 
III. Other sponsor’s obligations  
1. The sponsor shall undertake to keep availa ble for the competent national authorities 
any documentation necessary to provide evidence for the documentation referred to in Chapter II of this  Annex. If the sponsor is not  the natural or  legal person 
responsible for the manufacture of the inve stigational device, th is obligation may be 
fulfilled by that person on behalf of the sponsor. 
2. The reportable events shall be provided by the investigator(s) in timely conditions.  
EN 170   EN 3. The documentation mentioned in this Annex sh all be kept for a pe riod of time of at 
least five years after the clinical investiga tion with the device in question has ended, 
or, when the device is subsequently placed on the market, at least five years after the last device has been placed on the market. In the case of implantable devices the period shall be at least 15 years.  
Each Member State shall make provision th at this documentation is kept at the 
disposal of the competent authorities for th e period indicated in the first sentence of 
the preceding paragraph in case the sponsor, or his contact person, established within 
its territory goes bankrupt or ceases its activity prior to the end of this period.  
EN 171   EN ANNEX XV 
LIST OF PRODUCTS COVERED BY THE LAST SUBPARAGRPAH OF THE DEFINITION 
OF ‘MEDICAL DEVICE ’ REFERRED TO IN NUMBER (1) OF ARTICLE 2(1) 
1. Contact lenses;  
2. Implants for modification or  fixation of body parts;  
3. Facial or other dermal or mucous membrane fillers; 
4. Equipment for liposuction; 
5. Invasive laser equipment intended to be used on the human body; 
6. Intense pulsed light equipment.  
EN 172   EN ANNEX XVI 
CORRELATION  TABLE   
Council Directive 
90/385/EEC Council Directive 
93/42/EEC This Regulation 
Article 1(1) Article 1(1) Article 1(1) 
Article 1(2) Article 1(2) Article 2(1) 
Article 1(3) Article 1(3) 1st subparagraph Article 1(5)1st subparagraph 
- Article 1(3) 2nd subparagraph Article 1(5)2nd subparagraph 
Article 1(4) and (4a) Article 1(4) and (4a) Article 1(4)1st subparagraph 
Article 1(5) Article 1(7) Article 1(6) 
Article 1(6) Article 1(5) Article 1(2) 
- Article 1(6) - 
 Article 1(8) Article 1(7) 
Article 2 Article 2 Article 4(1) 
Article 3 1st subparagraph Article 3 1st subparagraph Article 4(2) 
Article 3 2nd subparagraph Article 3 2nd subparagraph - 
Article 4(1) Article 4(1) Article 22 
Article 4(2) Article 4(2) Article 19(1) and (2) 
Article 4(3) Article 4(3) Article 19(3) 
Article 4(4) Article 4(4) Article 8(7) 
Article 4(5) point (a) Article 4(5) 1st subparagraph Article 18(6) 
Article 4(5) point (b) Article 4(5) 2nd subparagraph - 
Article 5(1) Article 5(1) Article 6(1)  
Article 5(2) Article 5(2) Article 6(2) 
Article 6(1) Article 5(3), Article 6 - 
Article 6(2) Article 7(1) Article 88  
EN 173   EN Article 7 Article 8 Articles 69 to 72 
- Article 9 Article 41 
Article 8(1) Article 10(1) Number (43) and (44) of 
Article 2(1), Article 61(1), 
Article 63(1) 
Article 8(2) Article 10(2) Article 61(3) and Article 
63(1)2nd subparagraph 
Article 8(3) Article 10(3) Article 63(2) and (4) 
Article 8(4) Article 10(4) Article 66 
Article 9(1) Article 11(1) Article 42(2) 
- Article 11(2) Article 42(4) 
- Article 11(3) Article 42(3) 
- Article 11(4) - 
- Article 11(5) Article 42(5) 
Article 9(2) Article 11 (6) Article 42(7) 
Article 9(3) Article 11(8) Article 9(3) 
Article 9(4) Article 11(12) Article 42(8) 
Article 9(5) Article 11(7) - 
Article 9(6) Article 11(9) Article 43(1) 
Article 9(7) Article 11(10) Article 43(3) 
Article 9(8) Article 11(11) Article 45(2) 
Article 9(9) Article 11(13) Article 47(1) 
Article 9(10) Article 11(14) - 
- Article 12 Article 20 
- Article 12a Article 15 
Article 9a(1) 1st indent Article 13(1) point (c) - 
Article 9a(1) 2nd indent Article 13(1) point (d) Article 3(1) 
- Article 13(1) point (a) Article 41(3)  
EN 174   EN - Article 13(1) point (b) Article 41(4) point (a) 
Article 10 Article 15 Articles 50 to 60 
Article 10a Article 14 Article 25 
Article 10b Article 14a Article 27 
Article 10c Article 14b Article 74 
Article 11(1) Article 16(1) Articles 33 and 34 
Article 11(2) Article 16(2) Article 29 
Article 11(3) Article 16(3) Article 36(2) 
Article 11(4) Article 16(4) - 
Article 11(5) Article 16(5) Article 45(4) 
Article 11(6) Article 16(6) Article 45(3) 
Article 11(7) Article 16(7)  Articles 31(2) and 35(1) 
Article 12 Article 17 Article 18 
Article 13 Article 18 Article 73 
Article 14 Article 19 Article 75 
Article 15 Article 20 Article 84 
Article 15a Article 20a Article 77 
Article 16 Article 22 - 
Article 17 Article 23 - 
- Article 21 - 
  
EN 175   EN LEGISLATIVE FINANCIAL STATEMENT  
1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE   
 1.1. Title of the proposal/initiative  
 1.2. Policy area(s) concerned in the ABM/ABB structure  1.3. Nature of the proposal/initiative  
 1.4. Objective(s)   1.5. Grounds for the proposal/initiative   1.6. Duration and financial impact   1.7. Management method(s) envisaged  
2. MANAGEMENT
 MEASURES   
 2.1. Monitoring and reporting rules  
 2.2. Management and control system   2.3. Measures to prevent fraud and irregularities  
3. ESTIMATED
 FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE   
 3.1. Heading(s) of the multiannual fina ncial framework and expenditure budget 
line(s) affected  
 3.2. Estimated impact on expenditure   
 3.2.1. Summary of estimated impact on expenditure   3.2.2. Estimated impact on ope rational appropriations  
 3.2.3. Estimated impact on appropriati ons of an administrative nature 
 3.2.4. Compatibility with the current  multiannual financial framework 
 3.2.5. Third-party participation in financing  
 3.3. Estimated impact on revenue 
EN 176   EN LEGISLATIVE FINANCIAL STATEMENT  
1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE   
1.1. Title of the proposal/initiative  
Proposal for a Regulation of the European Parliament and of the Council on medical 
devices, and amending Directive 2001/83/ EC, Regulation (EC) No 178/2002 and 
Regulation (EC) No 1223/2009.  
This financial statement also includes the costs related to the Proposal for a 
Regulation of the European Pa rliament and of the Council on in vitro  diagnostic 
medical devices which is based on the sa me organisational and IT infrastructure 
established by this Proposal.  
1.2. Policy area(s) concerned in the ABM/ABB structure64  
Health for Growth 
1.3. Nature of the proposal/initiative  
X The proposal/initiative relates to  a new action   
 The proposal/initiative relates to a new action following a pilot project/preparatory 
action65  
 The proposal/initiative relates to the extension of an existing action   
 The proposal/initiative relates to an action redirected towards a new action   
1.4. Objectives 
1.4.1.  The Commission’s multiannual strategi c objective(s) targeted by the 
proposal/initiative  
In the field of medical devices, the proposals aim  
1) to ensure a high level of human health and safety ,  
2) to ensure the functioning of the internal market , and  
3) to promote innovation  in medical technology for the benefit of patients and 
healthcare professionals. 
                                                 
64 ABM: Activity-Based Management – ABB: Activity-Based Budgeting. 
65 As referred to in Article 49(6)(a) or (b) of the Financial Regulation.  
EN 177   EN 1.4.2.  Specific objective(s) and ABM/ ABB activity(ies) concerned  
Specific objective 1:  Establish mechanisms to ensure harmonised implementation of 
the rules on medical devices by all Member States with a sustainable, efficient and 
credible management at EU level with acces s to internal and external technical, 
scientific and clinical expertise, a llowing improved coordi nation and resource-
sharing between Member States.  
Specific objective 2:  Enhance transparency regard ing medical devices on the EU 
market, including their traceability.  
ABM/ABB activity(ies) concerned  
Health for Growth 
The Commission's Proposal for a Regulation of  the European Parliament and of the 
Council on establishing a Health for Gr owth Programme for the period 2014-2020 
(COM[2011]709) lists contribution to the objec tives of the EU legislation in the field 
of medical devices as one of the eligible actions to be financed by the programme.  
1.4.3.  Expected result(s) and impact 
Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 
On patients and healthcare professionals: Hi gh level of human health and safety; 
cases of deliberate circum vention of the legal requirements (e.g. PIP case) are 
prevented or quickly identified. High level of transparency and traceability regarding 
medical devices on the market (e.g. publicly  accessible Eudamed; UDI; implant card; 
summary of safety and performance) allowing better informed decision-making and 
follow-up. High level of confidence in the EU regulations.  
On manufacturers of medical devices: Leve l playing field due to  clearer rules and 
obligations, benefiting in particular th e large majority of manufacturers which 
already comply with the sp irit of the current legisla tion. Benefits from smoother 
functioning of the internal market. Support to innovation due to predictable 
regulatory framework conditions (e.g. early  scientific advice). Lower overall 
administrative burdens due to central regist ration of devices and reporting of serious 
incidents.  
On notified bodies: Safeguard their role in  pre-market medical device assessment. 
Level playing field due to clearer rules and obligations, benefiting in particular those 
notified bodies which already comply with the spirit of the current legislation. 
Reinforcement of their positi on vis-à-vis manufacturers. 
On national authorities: Reinforcement of their enforcement powers. Clear legal 
framework for coordination between them  and resource- and work-sharing.  
1.4.4.  Indicators of results and impact  
Specify the indicators for monitoring implementation of the proposal/initiative. 
Number of patients harmed  by unsafe medical devices.  
EN 178   EN Number of designated notifie d bodies, their areas of co mpetence and the level of 
diversification.  
Number of registrations (medical devices, economic operators, certificates), incident 
reports, single applications for clinical  investigations and market surveillance 
measures in the Eudamed databank with  its several new electronic systems. 
Number of preliminary conformity asse ssments "called up" under the scrutiny 
mechanism and number of comments emitted by MDCG. 
Number of coordinated actions between na tional competent authorities regarding 
post-market safety issues (vig ilance and market surveillance). 
Number of 'borderline cases' solved.  
Number of devices fitted with an UDI syst em that is aligned with international 
practice. 
1.5. Grounds for the proposal/initiative  
1.5.1.  Requirement(s) to be met in the short or long term  
The existing regulatory framework is being criticised for not sufficiently ensuring 
patient safety within the internal market and for being intransparent. The criticism 
has become even louder after findings of the French health authorities that a French 
manufacturer ( Poly Implant Prothèse , PIP) over several y ears apparently used 
industrial silicone instead of medical grad e silicone for the manufacture of breast 
implants contrary to  the approval provided by th e notified body, causing harm to 
thousands of women around the world.  
In an internal market with currently 32 participating countries (EU, EFTA, Turkey) 
and subject to constant technological and sc ientific progress, im portant divergences 
in the interpretation and app lication of the rules have emerged, thus undermining the 
directives' main objectives, i.e. the sa fety of medical devices and their free 
circulation within the internal market. Mo reover, regulatory gaps or uncertainties 
exist with regard to certa in products (e.g. products manuf actured utilising non-viable 
human tissues or cells; implantable or other invasive products for cosmetic 
purposes).  
The present revision aims to overcome these flaws and gaps and to put in place a 
robust, transparent and sustainable regulat ory framework that is 'fit for purpose'. 
1.5.2.  Added value of EU involvement  
The proposed revision of the existing dire ctives concerning medical devices, which 
will integrate the modification of the Lisbon Treaty regarding public health, can only 
be achieved at Union level. The proposal s are based on Artic le 114 and Article 
168(4)(c) of the Treaty on the Functi oning of the European Union (TFEU).  
EU action is necessary to improve the leve l of protection of pub lic health for all 
European patients and users, as well as to prevent Member States from adopting  
EN 179   EN varying product regulations which would result in a fu rther fragmentation of the 
internal market. Harmonised rules and pr ocedures allow manufacturers, especially 
SMEs that represent more than 80% of the sector, to reduce cost s related to national 
regulatory differences, while ensuring a hi gh and equal level of safety for all 
European patients and users. In accordance w ith the principles of proportionality and 
subsidiarity, as set out in Article 5 of the Treaty on European Union, this proposal 
does not go beyond what is necessary  to achieve those objectives. 
1.5.3.  Lessons learned from simila r experiences in the past 
The existing directives concerning medical devices, which date back to the 1990ies, 
have set harmonised requirements to be met by medical devices placed on the EU 
market. But they have not provided for mechanisms that ensure a harmonised 
implementation. As mentioned under 1.5. 1., important divergences in the 
interpretation and application of the rules have emerged, thus undermining the 
directives' main objectives, i.e. the sa fety of medical devices and their free 
circulation within the internal market.  
In addition, lessons drawn from an analysis  of the shortcomings brought to light by 
the PIP case have been taken into account  for the drafting of these proposals.  
1.5.4.  Coherence and possible synergy wi th other relevant instruments 
Enhanced coherence is expected with othe r legislations (e.g. concerning medicinal 
products, food, biocides, cosmetics) in terms of better delimitation of the respective 
scopes of application and/or in term s of solution of 'borderline cases'. 
Synergies are expected with the legisl ation regarding medicinal products, in 
particular as regards the assessment of drug-device combination products and as 
regards clinical rese arch regarding medicinal products (in the context of the revised 
Clinical Trials Directive) and regarding medical devices (in the context of this 
proposal) and/or performance evaluation stud ies with IVDs (in the context of the 
proposal for a Regulation on IVDs).   
EN 180   EN 1.6. Duration and financial impact  
 Proposal/initiative of limited duration  
–  Proposal/initiative in effect fr om [DD/MM]YYYY to [DD/MM]YYYY  
–  Financial impact from YYYY to YYYY  
X Proposal/initiative of unlimited duration  
– Implementation with a start-up period from 2014 to 2017, 
– followed by full-scale operation. 
1.7. Management mode(s) envisaged66  
X Centralised direct management  by the Commission  
 Centralised indirect management  with the delegation of implementation tasks 
to: 
–  executive agencies  
–  bodies set up by the Communities67  
–  national public-sector bodies/bodies with public-service mission  
–  persons entrusted with the implementation of specific actions pursuant to Title 
V of the Treaty on European Union and iden tified in the relevant basic act within 
the meaning of Article 49 of  the Financial Regulation  
 Shared management with the Member States  
 Decentralised management with third countries   
 Joint management with international organisations (to be specified) 
If more than one management mode is indicated, pl ease provide details in the "Comments" section. 
Comments  
The Commission intends to ensure the services concerned via centralised direct management 
through its own services, in particular via the JRC for the technical, sc ientific and logistic 
support.  
The centralised direct management by the Commission also applies to the further 
development and management of Eudamed (e lectronic systems regarding UDI; central 
registration of medical devices , economic operators and certifi cates; central reporting of 
                                                 
66 Details of management modes and references to the Financial Regulation may be found on the 
BudgWeb site: http://www.cc.cec/budg/man/b udgmanag/budgmanag_en.html  
67 As referred to in Article 185 of the Financial Regulation.  
EN 181   EN vigilance cases; market surveillance measures; c linical investigations) an d the IT tool for the 
notification of information rega rding new applications for conformity assessment concerning 
high risk devices by notified bodies and 'calle d up' preliminary assessm ents by them in the 
context of the scrutiny mechanism. 
It should be highlighted that the four EFTA countries  (via EEA Agreement and MRA with 
CH) and Turkey  (via Customs Union Agreement) will  participate in the management.   
EN 182   EN 2. MANAGEMENT  MEASURES   
2.1. Monitoring and reporting rules  
Specify frequency and conditions.  
The future Medical Device Coordination Gr oup (MDCG), set up by this Regulation, 
and its special working groups will provide  a regular platform to discuss issues 
related to the implementation of  the new regulatory framework.  
Ten years after entry into force, the Co mmission should report to the European 
Parliament and to the Council about the achievements of the 'medical device 
package'. The report should address the imp act of the new rules in respect of public 
health and patient safety, internal market , innovativeness and competitiveness of the 
medical device industry (with special atte ntion to SMEs). The Commission should 
consult competent authorities and stakehol ders (healthcare prof essionals, patients, 
manufacturers, notified bodies ) when preparing its report. 
2.2. Management and control system  
2.2.1.  Risk(s) identified  
Risks related to Eudamed:  
The development of the future Eudamed database would become too complex and 
would not meet the needs of the national competent authorities, the notified bodies, 
economic operators and the public at large.  
The IT infrastructure would not support the registration of  all medical devices placed 
on the EU market (several hundreds of thousands), or the reporting of serious 
incidents and field safety corrective actions  (several thousands a years), the reporting 
of market surveillance measur es, or the single submission of  applications for clinical 
investigations and the reporting of related serious adverse events.  
The non-public parts of the Eudamed da tabase with sensitive personal and 
commercial information would disclose conf idential information, e.g. due to hacking 
or software failure.  
Risks related to the conformity assessment of medical devices:  
By the date of application of the new Re gulations, an insuffici ent number of notified 
bodies would be designated in accordance with the new requirements which would 
lead to a delay for manufacturer s to get their devices approved. 
The scrutiny mechanism would be used  in a way that would delay, in a 
disproportionate manner, access to market of innovative medical devices. 
The IT tool for the notificat ion of information regardi ng new applications and/or 
submission of preliminary assessment s by notified bodies, which contains  
EN 183   EN commercially sensitive information, would disclose confidential information, e.g. 
due to hacking or software failure. 
2.2.2.  Control method(s) envisaged  
Control methods regarding ri sks related to Eudamed:  
The development of Eudamed is given high priority with a high level of sensitivity as 
regards its functioning.  
Close and regular contacts between the Co mmission services responsible for the 
management of the regulatory framework and the IT developers. 
Close and regular contacts between the Co mmission services/IT developers and the 
future users of the IT infrastructure.  
Control methods regarding risks related to  the conformity assessment of medical 
devices:  
The reinforced and coordinated supervision of notified bodies in the context of the 
'immediate action' initiated after the PIP scandal already takes account of the future 
requirements laid down in the proposal and thus supports a smooth transition.  
The Commission shall create guidance to ensure a proportionate and workable 
operation of the new scrutiny mechanism.  
The development of the IT tool is given hi gh priority with a high level of sensitivity 
as regards its functioning. 
2.3. Measures to prevent fraud and irregularities  
Specify existing or envisaged prevention and protection measures. 
In addition to the applicati on of all regulatory control mechanisms, the responsible 
Commission's services will devise an anti-fraud strategy in line with the 
Commission's new anti-fraud strategy (CA FS) adopted on 24 June 2011 in order to 
ensure inter alia  that its internal anti-fraud related controls are fully aligned with the 
CASF and that its fraud risk management appr oach is geared to identify fraud risk 
areas and adequate responses. Where nece ssary, networking groups and adequate IT 
tools dedicated to analysing fraud cases  related to the financing implementing 
activities of the Medical Devices Regulations will be set up. In part icular a series of 
measures will be put in place such as:  
- decisions, agreements and contracts re sulting from the financing implementing 
activities of the Medical De vices Regulations will expre ssly entitle the Commission, 
including OLAF, and the Court of Auditors  to conduct audits, on- the-spot checks and 
inspections; 
- during the evaluation phase of a call for proposals/tender, the proposers and 
tenderers are checked against the published exclusion criteria base d on declarations 
and the Early Warning System (EWS);   
EN 184   EN - the rules governing the eligibility of cost s will be simplified in accordance with the 
provisions of the Financial Regulation; 
- regular training on issues related to fraud and irregularities is given to all staff 
involved in contract management as well as  to auditors and c ontrollers who verify 
the beneficiaries' declarations on the spot. 
Moreover, the Commission will control a strict  application of the rules on conflict of 
interests provided in the proposal.   
EN 185   EN 3. ESTIMATED  FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE   
3.1. Heading(s) of the multiannual financia l framework and expenditure budget 
line(s) affected  
• Existing expenditure budget lines  
In order of multiannual financial fram ework headings and budget lines. 
Operational resources which are necessary for implementation of this initiative 
will be covered by the allocations pr oposed under the Health for Growth 
Programme 2014-2020. 
Budget line  Type of  
expenditureContribution  
Heading of 
multiannual 
financial 
framework Number  
[Description: Health for Growth Programme]  Diff./non-
diff. 
(68) from 
EFTA69 
countries from 
candidate 
countries70 from third 
countries within the 
meaning of Article 
18(1)(aa) of the 
Financial 
Regulation  
3 17.03.XX. 
 Diff/non -
diff. YES/NO  YES/ NO 
(to be 
determined 
whether 
Turkey – in 
the context 
of the 
Customs 
Union and 
as 
candidate 
country – 
should 
contribute.)  YES/ NO YES/ NO 
                                                 
68 Diff. = Differentiated appropriations / Non- diff. = Non-Differentiated Appropriations 
69 EFTA: European Free Trade Association.  
70 Candidate countries and, where applicable, poten tial candidate countries from the Western Balkans.  
EN 186   EN 3.2. Estimated impact on expenditure  
3.2.1. Summary of estimated impact on expenditure (in current prices)   
EUR million (to 3 decimal places)  
Heading of multiannual financial 
framework:  Number 
3 Citizenship (Health for Growth Programme) 
 
DG SANCO   Year 
2014 Year 
2015 Year 
2016 Year 
2017 Year 
2018  2019 et sq years 
 TOTAL 
y Operational appropriations71          
Commitments (1) 5,296 5,677 6,667 7,662 7,590 7,742 7,742  48,376 
Number of budget line: 17.03.XX72 Payments (2) 2,648 5,486 6,172 7,165 7,626 7,666 7,742 
+ 3,871 48,376 
                     
Appropriations of an administrative nature financed 
 from the envelope for specific programmes73          
Number of budget line:   (3)         
Commitments =1+1a 
+3 5,296 5,677 6,667 7,662 7,590 7,742 7,742  48,376 TOTAL appropriations 
for DG SANCO Payments =2+2a 2,648 5,486 6,172 7,165 7,626 7,666 7,742 
+ 3,871 48,376 
                                                 
71 Costs for development of IT and for technical/scientific support.  
72 The cost of the action will be entirely covered by the envelope  of the Health for Growth pr ogramme under the budgetary line re lated to the relevant objective of the 
programme. 
73 Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (f ormer "BA" lines), indirect research, 
direct research.  
EN 187   EN +3 
 
  
Commitments (4) 5,296 5,677 6,667 7,662 7,590 7,742 7,742  48,376 
y TOTAL operational appropriations  
Payments (5) 2,648 5,486 6,172 7,165 7,626 7,666 7,742 
+ 3,871 48,376 
y TOTAL appropriations of an administrative nature 
financed from the envelope for specific programmes  (6)         
Commitments =4+ 6 5,296 5,677 6,667 7,662 7,590 7,742 7,742  48,376 TOTAL appropriations  
under HEADING 3B 
of the multiannual financial 
framework  Payments =5+ 6 2,648 5,486 6,172 7,165 7,626 7,666 7,742 
+ 3,871 48,376 
If more than one heading is affect ed by the proposal / initiative:  
Commitments (4)         y TOTAL operational appropriations  
Payments (5)         
y TOTAL appropriations of an administrative nature 
financed from the envelope for specific programmes  (6)         
Commitments =4+ 6         TOTAL appropriations  
under HEADINGS 1 to 4 
of the multiannual financial 
framework 
(Reference amount)  Payments =5+ 6         
  
EN 188   EN  
Heading of multiannual financial 
framework:  5 " Administrative expenditure " 
EUR million (to 3 decimal places) 
   Year 
2014 Year 
2015 Year 
2016 Year 
2017 Year 
2018  2019 et sq years  TOTAL 
DG SANCO 
y Human resources  2,413 2,413 2,413 2,413 2,413 2,413 2,413 16,891 
y Other administrative expenditure  0,469 0,478 0,488 0,497 0,508 0,519 0,519 3,478 
TOTAL DG SANCO Appropriations  2,882 2,891 2,901 2,910 2,921 2,932 2,932 20,369 
 
TOTAL appropriations 
under HEADING 5 
of the multiannual financial 
framework   (Total commitments 
= Total payments) 2,882 2,891 2,901 2,910 2,921 2,932 2,932 20,369 
EUR million (to 3 decimal places) 
   Year 
2014 Year 
2015 Year 
2016 Year 
2017 Year 
2018  2019 et sq years  TOTAL 
Commitments  8,178 8,568 9,568 10,572 10,511 10,674 10,674 68,745 TOTAL appropriations  
under HEADINGS 1 to 5 
of the multiannual financial 
framework   Payments  5,530 8,377 9,073 10,075 10,547 10,598 10,674
+ 3,871  68,745  
EN 189   EN 3.2.2.  Estimated impact on opera tional appropriations  
–  The proposal/initiative does not requir e the use of operational appropriations  
– X The proposal/initiative requires the use of ope rational appropriations, as explained below: 
Commitment appropriations in EU R million (to 3 decimal places) 
  Year 
2014 Year 
2015 Year 
2016 Year 
2017 Year 
2018  2019 et sq years  TOTAL  
OUTPUTS  Indicate 
objectives 
and 
outputs  
 
Ø Type of 
output74 Avera
ge 
cost  
of the 
output 
Number 
of outputs Cost 
Number 
of outputs Cost 
Number 
of outputs Cost 
Number 
of outputs Cost 
Numbe r 
of out puts 
Cost 
Number 
of outputs Cost 
Number 
of outputs Cost Total 
numbe
r of 
output
s Total  
cost 
SPECIFIC OBJECTIVE No 1  Establish mechanisms to ensure harmonised implementation of the rules by all Member States with  a sustainable, efficient and 
credible management at EU level with access to internal and external technical, scientif ic and clinical expertise, allowing imp roved 
coordination and resource-sharing between Member States 
- Output Meetings of 
MDCG  80 
meet
ing 
days 1,873  
80 
meet
ing 
days1,910 80 
meeting 
days 1,948 80 
meeting 
days 1,987 80 
me
eti
ng 
da
ys2,027  
80 
meeti
ng 
days2,068  
80 
meeti
ng 
days2,068   
13,881 
- Output Technical and 
scientific opinions and 
advice   0,406  0,690  1,580  2,473  2,523  2,573  2,573  12,818 
                                                 
74 Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc .).  
EN 190   EN - Output Audits / 'joint 
assessments' of 80 notified 
bodies   0,416  0,424  0,433  0,442  0,450  0,459  0,459  3,083 
Sub-total for specific objective N°1  2,695  3,024  3,961  4,902  5,000  5,100  5100  29,782 
SPECIFIC OBJECTIVE No 2 Enhance transparency regarding medical devices on the EU market, incl uding their traceability 
- Output Eudamed 
(with 6 
electronic systems: UDI, 
registration, 
certificates, clinical inv., 
vigilance, 
market surv.), as of 2018 with statistical 
analysis / 
business intelligence) 
for signal 
detection  1 2,081 1 2,122 1 2,165 1 2,208 1 2,027 1 2,068 1 2,068  14,739 
- Output Translations, 
info 
campaigns, publications 
etc.   tbd 0,520 tbd 0,531 tbd 0,541 tbd 0,552 tb
d 0,563 tbd 0,574 tbd 0,574  3,855 
Sub-total for specific objective N°2  2,601  2,653  2,706  2,760  2,590  2,642  2,642  18,594 
 
Total costs  5,296  5,677  6,667  7,662  7,590  7,742  7,742  48,376   
EN 191   EN 3.2.3.  Estimated impact on appropriations  of an administrative nature 
3.2.3.1.  Summary  
–  The proposal/initiative does not re quire the use of administrative 
appropriations  
– X The proposal/initiative requires the us e of administrative appropriations, as 
explained below: 
EUR million (to 3 decimal places) 
 Year 
2014 Year 
2015 Year 
2016 Year 
2017 Year 
2018  2019 et sq years  TOTAL 
 
HEADING 5 
of the multiannual 
financial framework         
Human resources  2,413  2,413  2,413 2,413 2,413 2,413  2,413 16,891 
Other administrative 
expenditure  0,469 0,478 0,488 0,497 0,508 0,519 0,519 3,478 
Subtotal HEADING 5 
of the multiannual 
financial framework  2,882 2,891 2,901 2,910 2,921 2,932 2,932 20,369 
 
Outside HEADING 575 
of the multiannual 
financial framework          
H u m a n  r e s o u r c e s           
Other expenditure  
of an administrative 
nature         
Subtotal  
outside HEADING 5 
of the multiannual 
financial framework          
 
TOTAL  2,882 2,891 2,901 2,910 2,921 2,932 2,932 20,369
                                                 
75 Technical and/or administrative assistance and expenditure in support of the implementation of EU 
programmes and/or actions (former "BA" li nes), indirect research, direct research.  
EN 192   EN 3.2.3.2.   Estimated requirements of human resources  
–  The proposal/initiative does not require the use of human resources  
– X The proposal/initiative re quires the use of human resources, as explained 
below: 
Estimate to be expressed in full amounts (or at most to one decimal place) 
 Year 
2014  Year 
2015  Year 
2016  Year 
2017  Year 
2018  Year 
2019  Year 
>2019  
y Establishment plan posts (officials and temporary agents)  
17 01 01 01 (Headquarters and Commission’s 
Representation Offices)  19 19 19 19 19 19 19 
XX 01 01 02 (Delegations)        
XX 01 05 01 (Indirect research)        
10 01 05 01 (Direct research)        
y External personnel (in Full Time Equivalent unit: FTE)76 
XX 01 02 01 (CA, INT, SNE from the "global 
envelope")         
XX 01 02 02 (CA, INT, JED, LA and SNE in 
the delegations)        
- at Headquarters78        
XX 01 04 yy 77 
- in delegations         
XX 01 05 02 (CA, INT, SNE - Indirect 
research)        
10 01 05 02 (CA, INT, SNE - Direct research)        
Other budget lines (specify)        
TOTAL  19 19 19 19 19 19 19 
XX is the policy area or budget title concerned. 
The human resources required will be met by  staff from DG SANCO who are already 
assigned to the management of the action and who will be redeployed within DG SANCO, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation  procedure and in the light of budgetary 
constraints (estimated needs: 16 AD/FTE and 3 AST/FTE) . 
Description of tasks to be carried out: 
Officials and temporary agents Control of appropriate implementation of this Regulation; development of 
delegated/implementing acts and guidance; development of new electronic systems for 
Eudamed (in cooperation with IT staff); organisation and direction of 'joint 
assessments' of notified bodies and control of designation and monitoring process by 
Member States; coordination of market surveillance activities with EU wide impact; 
                                                 
76 CA= Contract Agent; INT= agency staff (" Intérimaire") ; JED= " Jeune Expert en Délégation" (Young 
Experts in Delegations); LA= Local Ag ent; SNE= Seconded National Expert;  
77 Under the ceiling for external personnel from operational appropriations (former "BA" lines). 
78 Essentially for Structural Funds , European Agricultural Fund for Rural Development (EAFRD) and 
European Fisheries Fund (EFF).  
EN 193   EN follow-up of national safeguard and preventive health protection measures; 
international regulatory cooperation; management of Medical Device Committee 
(committee within the mean ing of Reg. 182/2011). 
External personnel  
3.2.4.  Compatibility with the current multiannual financial framework  
– X Proposal/initiative is compatible with  the new multiannual financial framework 
2014-2020. 
–  Proposal/initiative will entail reprogramming of the relevant heading in the 
multiannual financial framework. 
Explain what reprogramming is required, specifying the budget lines concerned and the corresponding 
amounts. 
–  Proposal/initiative requires application of  the flexibility inst rument or revision 
of the multiannual financial framework79. 
Explain what is required, specifying the headings and budget lines concerned and the corresponding 
amounts. 
3.2.5.  Third-party contributions  
– The proposal/initiative does not provid e for co-financing by third parties  
– The proposal/initiative provides for the co-financing estimated below: 
Appropriations in EUR m illion (to 3 decimal places) 
 
Year 
N Year 
N+1 Year 
N+2 Year 
N+3 … enter as many years as 
necessary to show the duration 
of the impact (see point 1.6)  Total 
Specify the c o-financing 
body          
TOTAL appropriations 
cofinanced          
 
 
                                                 
79 See points 19 and 24 of the Interinstitutional Agreement.  
EN 194   EN 3.3. Estimated impact on revenue  
–  Proposal/initiative has no financial impact on revenue. 
–  Proposal/initiative has the following financial impact: 
– 1. on own resources 
– 2. on miscellaneous revenue 
EUR million (to 3 decimal places)  
Impact of the proposal/initiative80 
Budget revenue line: Appropriation
s available for 
the ongoing 
budget year 2014 2015 2016 2017 Subsequent years  
Article ………….  0 0 0 0 0 0 0 
For miscellaneous assigned revenue, specify  the budget expenditure line(s) affected. 
Specify the method for calcula ting the impact on revenue. 
                                                 
80 As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net 
amounts, i.e. gross amounts after deduction of 25% for collection costs.