EN    EN  
 EUROPEAN COMMISSION 
Brussels, 26.9.2012  
COM(2012) 541 final 
2012/0267 (COD) 
  
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on in vitro  diagnostic medical devices  
(Text with EEA relevance) 
{SWD(2012) 273} 
{SWD (2012 ) 274}   
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL 
The current EU regulatory framework for in vitro  diagnostic medical devices ('IVDs') consists 
of Directive 98/79/EC of the European Parliame nt and of the Council ('the IVD Directive')1 
IVDs cover a wide range of products that can  be used for population screening and disease 
prevention, diagnosis, monitoring of prescrib ed treatments and assessment of medical 
interventions. 
Like Council Directive 90/ 385/EEC on active implantable  medical devices (AIMDD)2 and 
Council Directive 93/42/EEC  on medical devices (MDD)3 the IVD Directive is based on the 
'New Approach' and aims to ensure the smooth f unctioning of the internal market and a high 
level of protection of human health and safe ty. IVDs are not subject to any pre-market 
authorisation by a regula tory authority but to a conformity  assessment which, for the majority 
of devices, is carried out under the sole respons ibility of the manufact urer. For the high-risk 
devices listed in Annex II and devices for self -testing, the conformity assessment involves an 
independent third party, known as 'notifie d body'. Notified bodies are designated and 
monitored by the Member States and act under th e control of the national authorities. Once 
certified, devices bear the CE marking which al lows them to circulate freely in the EU/EFTA 
countries and Turkey. 
The existing regulatory framework for in vitro  diagnostic medical devices has demonstrated 
its merits but has also come under criticism in recent years.  
In an internal market with 32 participating countries4 and subject to cons tant scientific and 
technological progress, substant ial divergences in th e interpretation and application of the 
rules have emerged, thus undermining the main object ives of the Directive, i.e. the safety and 
performance of IVDs and their free movement.  
This revision aims to overcome these flaws and divergences and to further strengthen patient 
safety. A robust, transparent and su stainable regulatory framework for in vitro  diagnostic 
medical devices that is 'fit for purpose' should be put in place. This framework should be 
supportive of innovation and the competitiveness of the in vitro  diagnostic medical device 
industry and should allow rapid and cost-effici ent market access for innovative IVDs to the 
benefit of patients and healthcare professionals. 
This proposal is adopted alongs ide a proposal for a Regulation on medical devices that are 
currently covered by the AIMDD and the MDD. Wh ile the specific features of IVDs and of 
the IVD  sector require the adoption of a specific legi slation distinct from the legislation on 
other medical devices, the horizontal aspects common to both sectors have been aligned. 
2. RESULTS  OF CONSULTATIONS  WITH  THE  INTERESTED  PARTIES  AND  
IMPACT  ASSESSMENTS 
In preparation for the impact assessment on this  proposal and the proposal for a Regulation on 
medical devices, the Commission held two public cons ultations, 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 consultation of interested parties by the 
                                                
 
1 OJ L 331, 7.12.1998, p. 1. 
2 OJ L 189, 20.7.1990, p. 17. 
3 OJ L 169, 12.7.1993, p. 1. 
4 EU Member States, EFTA countries and Turkey.  
EN 3   EN Commission were applied; responses received with in a reasonable period after the deadlines 
were taken into account. After analysing 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 re lated to the revision of the IVD Directive 
and showed wide support for this initiative. 
During 2009, 2010 and 2011, the issues to be tack led in the revision of the regulatory 
framework for medical devices and in vitro  diagnostic medical de vices were regularly 
discussed at meetings of the Medical De vices Expert Group (MDEG), the Competent 
Authorities for Medical Devices (CAMD) and specific working groups in the fields of in vitro  
diagnostic medical devices (IVDs), notified b odies, borderline and cl assification, clinical 
investigation and evaluati on, vigilance and market su rveillance, and in an ad hoc  working 
group on Unique Device Identifi cation (UDI). A special meeti ng of the MDEG was held on 
31 March and 1 April 2011 to discuss issues re lated to the impact assessment. Moreover, the 
Heads of Medicines Agencies (HMA) and th e CAMD organised joint workshops on the 
development of the legal framework for medi cal 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 into 
account, where appropriate, for the further development of the proposals.  
In addition, Commission's repres entatives regularly 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.  
Aspects linked to the appropriate  regulatory framework were also  discussed in the course of 
the 'Exploratory Process on th e Future of the Medical De vice 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 se ctor in addressing the healthcare 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.  
                                                 
5 See http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm. 
6 OJ L 247, 21.9.2007, p. 21. 
7 OJ C 202, 8.7.2011, p. 7.  
EN 4   EN 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) 
To a large extent, the scope of the proposed  Regulation matches th e scope of Directive 
98/79/EC, i.e. it covers in vitro  diagnostic medical devices. Th e proposed changes clarify and 
extend the scope of the IVD Directive. They concern:  
• high-risk devices manufactured and used with in a single health institution, which are 
subject to most of the require ments set out in the proposal;  
• tests providing information about the predisposition to a medical condition or a 
disease (e.g. genetic tests)  and tests providing information to predict treatment 
response or reactions (e.g. companion di agnostics), which are considered as in vitro  
diagnostic medical devices ; 
• medical software, which is explicitly mentioned in the definition of IVDs. 
To support Member States and the Commission in determining the regulatory status of 
products, the Commission may set up, in ac cordance with its internal rules9, a group of 
experts from various sectors (such as IVDs, medical devices, medicinal products, human 
tissues and cells, cosmetics and biocides).  
The definitions section has been significantly extended, aligning th e definitions in the field of 
in vitro diagnostic medical devices with well-establis hed European and inte rnational practice, 
such as the New Legislative Framework for the Marketing of Products10 and guidance 
documents produced for in vitro diagnostic medical devices by the Global Harmonization 
Task-Force (GHTF)11 . 
3.2. Making available of devices, obligations  of economic operators, CE marking, 
free movement (Chapter II) 
This chapter covers mainly horizontal issues similar for both medical devices and IVDs. It 
contains provisions that are ty pical for product-related internal market legislation and sets out 
the obligations of the relevant  economic operators (manufacturers, authorised representatives 
of non-EU manufacturers, importe rs and distributors). It also provides clarif ication with 
regard to the adoption and the scope of common techni cal specifications (CTS) for in vitro  
diagnostic medical devices.  
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 
                                                 
8 Resolution of 14 June 2012 (2012/2621(RSP)); P7_TA-PROV(2012)0262, 
http://www.europarl.europa.eu/plen ary/en/texts-adopted.html  
9 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. 
10 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. 
11 http://www.ghtf.org/  
EN 5   EN 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 manuf acturers of low-risk devices.  
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 the devices placed on the market. Their minimum contents are laid down in 
Annexes II and III.  
The following concepts are new in the field of IVDs:  
• A requirement has been introduced that wi thin 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 Directive on medical devices in some Member States.  
• Since in the case of 'parallel trade' with in vitro  diagnostic medical devices 
application of the principle of free movement of goods varies considerably from one 
Member State to another and, in many cases, de facto  prohibits this practice, clear 
conditions are set for enterprises involved in relabelling and/or repackaging IVDs. 
3.3. Identification and traceability of devices , registration of devices and of economic 
operators, summary of safety and p erformance, 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 shal l be able to identify who supplied them 
and to whom they have supplied IVDs; 
• 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 shall 
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/EU12, 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 
performance studies, on vigilance and on ma rket 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.  
                                                
 
12 OJ L 102, 23.4.2010, p. 45.  
EN 6   EN 3.4. Notified bodies (Chapter IV) 
Proper functioning of notified bodies is crucial fo r ensuring a high level of  health and safety 
and citizens' confidence in the system, which ha s come under severe criticism in recent years 
due to significant differences as regards, on the one hand, the designa tion and monitoring of 
notified bodies and, on the other, the qual ity and depth of the conformity assessment 
performed by them.  
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 expert s from other Member States 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 assessment of IVDs at a ppropriate intervals to strike 
a reasonable balance between the knowledge an d experience required to carry out thorough 
assessments and the need to ensure continuous objectivity and ne utrality in relation to the 
manufacturer subject to those assessments. 
3.5. Classification and conformi ty assessment (Chapter V) 
Annex II to the IVD Directive addresses the le vel of risk posed by IVD medical devices by 
means of a positive list system. While this system  was adapted to scientific and technological 
development at the time the IVD Directive was written, today it can no  longer keep up with 
the fast pace of scien tific and technological progress. The pr oposal introduces  a new risk-rule 
based classification system, built on GHTF principles, which replaces the current list of IVD medical devices in Annex II to Directive 98/79/EC.  
In the new classification system, IVDs will be divided into four classes of risk: A (lowest 
risk), B, C and D (highest risk). The conform ity assessment procedures have been adapted to 
match each of these four device classes, us ing the existing modules established under the 
'New Approach'. The conformity assessment proce dure for class A devices will be car ried out, 
as a general rule, under the sole responsibility of  the manufacturer in view of the low level of 
vulnerability associated with these products. Ho wever, when class A devices are intended for 
near-patient testing, have a meas uring function or are sold ster ile, a notified body shall verify 
respectively the aspects relate d to design, the measuring func tion or to the sterilisation 
process. For devices of classes B, C and D an appropriate level of involvement of a notified 
body is compulsory proportionate to the risk cla ss, with devices of class D requiring explicit 
prior approval of the design or of the type of  the device and of the quality management system 
before they may be placed on the market. In the case of class B and C devices, the notified 
body checks the quality management system and, for class C, the technical documentation of 
representative samples. Afte r initial certification, notifie d bodies shall regularly conduct 
surveillance assessments 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  
EN 7   EN have been tightened and streamlined. One co nformity assessment procedure provided for 
under the IVD Directive (EC veri fication) has been deleted as  the responses to the public 
consultation highlighted that it was under-use d. The concept of batch testing has been 
clarified. The proposal reinforces the powers and responsibilities of notified bodies and 
specifies the rules according 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 factory inspections, sample checks) to ensure a level playing field and 
avoid notified bodies being ove rly lenient. Manufacturers of  devices for performance 
evaluation continue to be subj ect to specific provisions.  
In addition, the proposal intr oduces the obligation for notifie d bodies to notify an expert 
committee of new applications for conform ity assessment of hi gh-risk devices. On 
scientifically valid health grounds, the expert committee will have the power to request the 
notified body to submit a preliminary assessmen t on which the committee can issue comments 
within a deadline of 60 days
13, before the notified body can issu e a certificate. This scrutiny 
mechanism empowers the authorities 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 medical devi ces manufactured utilising animal tissues 
(Commission Directive 2003/32/EC14). Its use should be the excep tion rather than the rule and 
should follow clear and tr ansparent criteria.  
3.6. Clinical evidence (Chapter VI) 
The proposal spells out the require ments for clinical evidence for  in vitro  diagnostic medical 
devices which are proportionate to the risk class.  The key obligations are set out in Chapter VI 
while more detailed provisions  are laid down in Annex XII. 
While most clinical performance studies foll ow an observational design and therefore the 
results obtained are not used for patient manage ment and do not impact treatment decisions, 
specific requirements have been introduced in  Annex XIII for the conduct of interventional 
clinical performance studies a nd other clinical performance st udies where the conduct of the 
study, including specimen collec tion, involves invasive procedur es or other risks for the 
subjects of the studies.  
The concept of 'sponsor' is introduced and alig ned with the definitio n used in the recent 
Commission's proposal for a Regulation of the European Parliament and of the Council on 
clinical trials on medicinal products for hum an use which aims at repealing Directive 
2001/20/EC15.  
The sponsor can be the manufacturer, his authoris ed representative or another organisation, in 
practice often a ‘contract rese arch organisation’ conducting c linical performance studies for 
the manufacturers. The scope of the proposal , however, remains restricted to clinical 
performance studies carried out for regulator y purposes, i.e. for obtaining or confirming 
regulatory approval for market access. Non-comme rcial clinical performance studies that do 
not pursue a regulatory purpose are not covered by this Regulation. 
In accordance with recognised international ethical  principles, every interventional clinical 
performance study and other clinical performan ce study involving risks for the subjects of the 
                                                 
13 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. 
14 OJ L 105, 26.4.2003, p. 18. This directive will be replaced by a Commission Regulation (EU) No 
722/2012 (OJ L 212, 9.8.2012, p. 3) with effect from 29 August 2013. 
15 COM(2012)369.  
EN 8   EN study shall be registered in a publicly accessibl e electronic system which the Commission will 
set up. To ensure synergies with the area of clinical trials on me dicinal products, the 
electronic system on interventional clinical  performance studies and other clinical 
performance studies involving risks for the subj ects of the studies should be interoperable 
with the future EU database to be set up in accordance with the future Regulation on clinical 
trials on medicinal products for human use. 
Before commencing an interventional clinical  performance study or any other clinical 
performance study involving risks for the subjec ts of the study, the sponsor shall submit an 
application to confirm that there are no health  and safety aspects or  ethical aspects which 
would oppose it. A new possibility will be opened up for sponsors of an interventional clinical 
performance study or any other clinical perfor mance study involving risks for the subjects of 
the study to be conducted in more than one Member  State: in future they may, if they wish, 
submit a single application through the electronic  system to be set up by the Commission. As 
a consequence, the health and safety-related aspects regarding the device for performance 
evaluation will be assessed by the Member St ates concerned under the direction of a 
coordinating Member State. The assessment of intrinsically national, local and ethical aspects (e.g. liability, suitability of the investigators an d clinical performance studies sites, informed 
consent), will however, need to be carried out at the level of each Member State concerned 
which will retain the ultimate responsibility for deciding whether the clinical performance 
study may be conducted on its territory. In line with the above-mentioned Commission's 
Proposal for a Regulation on clinical  trials on medicinal products, also this proposal leaves it 
to the Member States to define the organisatio nal set-up at national level for the approval of 
interventional clinical performance studies or  any other clinical performance study involving 
risks for the subjects of the study. In other wo rds, 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 
because complications with devices may come to  light only after a certain period of time. The 
main progress which the proposal will bring in th is field is the introduction of an EU portal 
where manufacturers shall report serious incide nts and corrective actions  they have taken to 
reduce the risk of recurrence. The information will be automatically made available 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 analysis 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 fields of medical 
devices and in vitro  diagnostic medical devices and set up by Regulation (EU) [Ref. of future 
Regulation on medical devi ces] on medical devices
16. The MDCG and its subgroups will 
allow to build a forum for discussions with st akeholders. The proposal creates the legal basis 
                                                 
16 OJ L […], […], p. […]  
EN 9   EN that for specific hazards or technologies or for verifying compliance with common technical 
specifications by devices posing th e highest risk, EU reference la boratories, 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 identif ied as preferred option 
either the extension of the responsibility of  the European Medicines Agency (EMA) to in 
vitro  diagnostic medical devices or the management of the in vitro  diagnostic medical devices 
regulatory system by the Comm ission. Taking into account the cl ear preference expressed by 
stakeholders, including many Member States , the proposal mandates the Commission to 
provide technical, scient ific and logistic s upport 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 this Regulation, or dele gated acts to complement the 
regulatory framework for in vitro  diagnostic medical devices over time. 
The new Regulation will become ap plicable five years after its entry into force in order to 
take into account the significant changes to th e classification system for IVDs and to the 
conformity assessment procedures. This will, on the one hand, allow time to set up a sufficient number of notified bodies, and, on th e other hand, mitigate the economic impact on 
manufacturers. The Commission needs also time to  put in place the IT in frastructure and the 
organisational arrangements necessary for the fu nctioning 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 this Regulation in order to ensure that by the date of its application, sufficient notified bodies are desi gnated in accordance with the new rules to 
avoid any shortage of in vitro diagnostic medical devices on the market. Special transitional 
provisions are foreseen for the registration of in vitro diagnostic medical devices, relevant 
economic operators and certificates  issued by notifie d bodies to allow for a smooth transition 
from registration requirements at national leve l to a central regist ration at EU level. 
The future Regulation will replace and repeal Dir ective 98/79/EC of the European Parliament 
and of the Council.  
3.10. Union competence, subsidiarity and legal form  
The proposal has a 'double legal basis', i.e. Article 114 and Article 168(4)(c) of the Treaty on 
the Functioning of the European Union. With the entry into force of the Lisbon Treaty, the 
legal basis for the establishment and functioning  of the internal market, on which the current 
Medical Devices Directives were adopted, has been complemented by a specific legal basis to set high standards for the quality and safety of  devices for medical use. In regulating IVDs, 
the Union is exercising its shared power under Article 4(2) of the Tr eaty on the Functioning 
of the European Union.  
Under the current IVD Directive, IVDs that b ear the CE marking can, in principle, move 
freely within the EU. The proposed revision of th e existing directive, wh ich will integrate the 
changes introduced by the Lisbon Treaty regard ing public health, can be achieved only at 
Union level. This is necessary in order to impr ove the level of protectio n of public health for 
all European patients and users, and also to prevent Member States from adopting diverging 
product regulations which would result in furt her fragmentation of the internal market. 
Harmonised rules and procedures allow manufactu rers, especially SMEs which make up more 
than 90% of the IVD sector, to  reduce costs related to nation al regulatory differences, while 
ensuring a high and equal level of safety th roughout the Union. In accordance with the 
principles of proportionality and subsidiarity, as set out in Article 5 of the Treaty on European  
EN 10   EN 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 tran sposition of the IVD Directive by Member 
States has led to different leve ls of health and safety protec tion and created obstacles to the 
internal market which only a Regulation 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 implementing the harmonised rules, e.g. as regards 
approval of clinical performance studies, the de signation of notified bodie s, the assessment of 
vigilance cases, the conduct of market surveillance and enforcement action ( 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 le vel of safety of in vitro diagnostic medical devices made available on 
the Union market. The proposal affects the freedom of economic operators to conduct 
business (Article 16) but the obligations  imposed on manufacturers, authorised 
representatives, importe rs and distributors of in vitro diagnostic 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 that any clinic al performance study with participation of 
human subjects is conducted re specting the human dignity, the right to physical and mental 
integrity of the persons concerned and the princi ple of free and informed consent, as required 
by Articles 1, 3(1) and 3( 2)(a) of the Charter. 
4. BUDGETARY
 IMPLICATION   
This proposal does not have any additional di rect budgetary implication because the cost-
relevant arrangements are alre ady covered by the proposal for a Regulation on medical 
devices. The financial statement of that proposal lists the details of th e costs related to the 
implementation of both Regulations. A thorough di scussion on the costs is contained in the 
impact assessment report.  
EN 11   EN 2012/0267 (COD) 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on in vitro  diagnostic medical devices  
(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
17, 
Having regard to the opinion of  the Committee of the Regions18, 
After consulting the European  Data Protection Supervisor19, 
Acting in accordance with the or dinary legislative procedure, 
Whereas: (1) Directive 98/79/EC of the European Parlia ment and of the Counc il of 27 October 1998 
on in vitro diagnostic medical devices
20 constitutes the Union regulatory framework 
for in vitro diagnostic medical devices. However,  a fundamental revision of that 
Directive is needed to establish a robust, transparen t, predictable and sustainable 
regulatory framework for devices which ensu res a high level of safety and health 
whilst supporting innovation.  
(2) This Regulation aims to ensure the functi oning of the internal market as regards in 
vitro  diagnostic medical devices,  taking as a base a high level of prot ection of health. 
At the same time, this Regulation sets high standards of quality and safety for devices to meet common safety concerns as regard s those products. Both objectives are being 
pursued simultaneously and are inseparably linked whilst one not being secondary to 
the other. As regards Article 114 of the Treaty on the Functioning of the European 
Union, this Regulation harmonises the rules for the placing on th e market and putting 
into service of in vitro diagnostic medical 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) of the Treaty on the Functioning of the European Union, this 
Regulation sets high standards of quality and safety for those devices by ensuring, 
among other things, that data generated in cl inical performance studies is reliable and 
                                                
 
17 OJ C […], […], p. […]. 
18 OJ C […], […], p. […]. 
19 OJ C […], […], p. […]. 
20 OJ L 331, 7.12.1998, p.1  
EN 12   EN robust and that the safety of subjects participating in clin ical performance studies is 
protected. 
(3) Key elements of the existing regulatory appr oach, such as the s upervision of notified 
bodies, risk classification, conformity a ssessment procedures, clinical evidence, 
vigilance and market surveillance should be significantly reinfor ced, whilst provisions 
ensuring transparency a nd traceability regarding in vitro diagnostic medical devices 
should be introduced to improve health and safety.  
(4) To the extent possible,  guidance developed for in vitro  diagnostic medical devices at 
international level, in particular in the context of the Global Harmonization Task Force 
(GHTF) and its follow-up initiative the International Medical Devices Regulators Forum, should be taken into account to pr omote the global converg ence of regulations 
which contributes to a high level of safety  worldwide and to facilitate trade, in 
particular in the provisions on Unique Device Identification, general safety and 
performance requirements, technical documen tation, classification criteria, conformity 
assessment procedures and clinical evidence. 
(5) There are specific features of in vitro diagnostic medical devices, in particular in terms 
of risk classification, conformity assessment procedures and clinical evidence, and of 
the in vitro diagnostic medical device sector which require the adoption of a specific 
legislation, distinct from the legislation on other medi cal devices, whereas the 
horizontal aspects common to bot h sectors should be aligned. 
(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 
legislation concerning products such as medical devices, genera l laboratory products 
and products for research use only. 
(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 an in vitro  diagnostic medical device or  of an accessory to an in vitro  
diagnostic medical device.  
(9) To ensure the highest level of h ealth protection, the rules governing in vitro  diagnostic 
medical devices manufactured and used, including measurement and delivery of results, only within a single health institution should be clarified and strengthened. 
(10) It should be clarified that software specifically intended by the manufacturer to be 
used for one or more of the medical pur poses set out in th e definition of an in vitro  
diagnostic medical devi ce is qualified as an in vitro  diagnostic medical device, while 
software for general purposes, even when us ed in a healthcare setting, or software 
intended for well-being applications is not qualified as an in vitro diagnostic medical 
device. 
(11) It should be made clear that all tests that provide information on the predisposition to a 
medical condition or a disease (e.g. genetic test s) and tests that provide information to 
predict treatment response or reactions , such as companion diagnostics, are in vitro  
diagnostic medical devices.  
EN 13   EN (12) 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/EEC21 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/EC22 are an 
integral part of the general safety and performance requirements for in vitro  diagnostic 
medical devices. Consequently, this Regulation should be considered a lex specialis  in 
relation to those Directives. 
(13) This Regulation should include requirements  regarding the design and manufacture of 
in vitro  diagnostic medical devices emitting ioni sing radiation without affecting the 
application of Council Dir ective 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 radiation23, nor of Council Directive 
97/43/Euratom of 30 June 1997 on health protec tion of individuals against the dangers 
of ionising radiation in relation to me dical exposure and repealing Directive 
84/466/Euratom24 which pursue other objectives.  
(14) 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 Area25, the Agreement between the European Community and the Swiss 
Confederation on mutual recognition in relation to conformity assessment26 and the 
Agreement of 12 September 1963 establishing  an association between the European 
Economic Community and Turkey27. 
(15) It should be made clear that in vitro  diagnostic 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 informati on in the field of technical standards and 
regulations28 as well as devices used in the contex t of a commercial ac tivity to provide 
a diagnostic or therapeu tic service to persons  within the Union 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. 
(16) To recognise the important role of  standardisation in the field of in vitro  diagnostic 
medical devices, compliance with harmonised standards as defined in Regulation (EU) 
No [Ref. of future Regulation on Euro pean standardisation] on European 
standardisation29 should be a means for manufacturers to demonstrate conformity with 
the general safety and performance requireme nts and other legal requirements, such as 
quality and risk management. 
                                                 
21 OJ L 390, 31.12.2004, p. 24 
22 OJ L 157, 9.6.2006, p. 24. 
23 OJ L 159, 29.6.1996, p. 1. 
24 OJ L 180, 9.7.1997, p. 22. 
25 OJ L 1, 3.1.1994, p. 3. 
26 OJ L 114, 30.4.2002, p. 369. 
27 OJ 217, 29.12.1964, p. 3687 
28 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. 
29 OJ C […], […], p. […].  
EN 14   EN (17) The definitions in the field of in vitro  diagnostic medical devices, for example, 
regarding economic operators, clinical eviden ce and vigilance, should be aligned with 
well-established practice at Union and intern ational level in order to enhance legal 
certainty. 
(18) The rules applicable to in vitro  diagnostic medical devices should be aligned, where 
appropriate, with the New Legislative Fr amework for the Marketing 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 re quirements for accreditation and market 
surveillance relating to the marketing of products and repealing Regulation (EEC) No 
339/9330 and Decision No 768/2008/EC of the European Parliament and of the 
Council of 9 July 2008 on a common framework for the ma rketing of products, and 
repealing Council Decision 93/465/EEC31. 
(19) The rules on Union market surveillance a nd control of products entering the Union 
market provided for in Regula tion (EC) No 765/2008 apply to in vitro  diagnostic 
medical devices and their accessories c overed by this Regulation which does not 
prevent Member States from choosing the competent authorities to carry out those tasks. 
(20) It is appropriate to set out  clearly the general obligati ons of the different economic 
operators, including importers a nd distributors, as laid do wn 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 
legal requirements and thus to improve regulatory compliance by the relevant 
operators. 
(21) To ensure that in vitro  diagnostic medical devices manuf actured in series production 
continue to be in conformity with the requirements of this Regulation and that 
experience from the use of their in vitro  diagnostic medical de vices is taken into 
account for the production process, al l manufacturers should have a quality 
management system and a post-market surveillance plan in place which should be proportionate to the risk cl ass and the type of the in vitro  diagnostic medical device. 
(22) It should be ensured that supervisi on and control of the manufacture of in vitro  
diagnostic medical devices is carried out w ithin the manufacturer's organisation by a 
person who fulfils minimum conditions of qualification. 
(23) For manufacturers who are not established in the Union, the authorised representative 
plays a pivotal role in en suring the compliance of the in vitro  diagnostic medical 
devices produced by those manufacturers an d in serving as th eir contact person 
established in the Union. The tasks of an au thorised representative  should be defined 
in a written mandate with the manufact urer which for example may allow the 
authorised representative to lodge an application for a conformity assessment 
procedure, to report events under the vigilan ce system or to register devices placed on 
the Union market. The mandate should empower the authorised repres entative to duly 
fulfil certain defined tasks. Considering th e role of authorised representatives, the 
minimum requirements to be met by them should be clearly defined, including the 
requirement of having available a pers on who fulfils minimum conditions of 
qualification which should be similar to th ose for a manufacturer's qualified person 
                                                
 
30 OJ L 218, 13.8.2008, p.30. 
31 OJ L 218, 13.8.2008, p. 82.  
EN 15   EN but, with a view to th e authorised representative's task s, could also be satisfied by a 
person with qualification in law.  
(24) 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 an in vitro  diagnostic medical device. 
(25) 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 of the Treaty on the Functioning of the European Union subject to the limitations se t by the protection of health and safety 
and by the protection of intellectual prope rty rights provided by Article 36 of the 
Treaty on the Functioning of the European Un ion. Application of this principle is, 
however, subject to different interpretations in the Member  States. The conditions, in 
particular the requirements for relabe lling and repackaging, should therefore be 
specified in this Regulation, taking into acc ount the case-law of the European Court of 
Justice
32 in other relevant sectors and exis ting good practices in the field of in vitro  
diagnostic medical devices. 
(26) In vitro  diagnostic medical devices should, as a general rule, bear the CE marking to 
indicate their conformity with this Regulati on so that they can move freely within the 
Union and be put into service in accord ance with their intended purpose. Member 
States should not create obstacles to their placing on the market or putting into service 
for reasons related to the requireme nts laid down in this Regulation. 
(27) The traceability of in vitro  diagnostic medical devices by means of a Unique Device 
Identification (UDI) system based on in ternational guidance should significantly 
enhance the effectiveness of the post-market safety of in vitro  diagnostic medical 
devices due to improved incident reporting, targeted field safety corrective actions and 
better monitoring by competent authorities. It should also  help to reduce medical 
errors and to fight against counterfeit de vices. Use of the UDI system should also 
improve purchase-policy and stock-management by hospitals. 
(28) 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. 
(29) 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 in vitro  diagnostic medical device s on the market and the 
relevant economic operators, certificates, in terventional clinical performance studies 
and other clinical performance studies invol ving risks for the subjects of the studies, 
vigilance and market surveillance. The obj ectives of the database are to enhance 
overall transparency, to streamline and faci litate the flow of information between 
economic operators, notified bodies or s ponsors and Member States as well as 
between Member States among themselves  and with the Commission, to avoid 
multiple reporting 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 therefore furthe r develop and manage the European 
databank on medical devices (Eudamed) by fu rther developing the databank set up by 
                                                
 
32 Judgment of the Court of 28 July 2011 in joined cases C-400/09 and C-207/10  
EN 16   EN Commission Decision 2010/227/EU of 19 Ap ril 2010 on the European Databank for 
Medical Devices33. 
(30) 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 clinical performance studies 
should serve as tool for the cooperation between Member States and for enabling sponsors to submit, on a voluntary basis, a single application for several Member 
States and, in this case, to  report serious adverse events . The electronic system on 
vigilance should enable manuf acturers to report serious in cidents and other reportable 
events and to support the coordination of  their assessment by national competent 
authorities. The electronic system regarding market surveillance should be a tool for 
the exchange of information between competent authorities. 
(31) 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 data
34 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 data35, 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. 
(32) For high-risk in vitro  diagnostic medical devices, ma nufacturers should summarise the 
main safety and performance aspects of th e device and the outcome of the clinical 
evaluation in a document that should be publicly available. 
(33) The proper functioning of notified bodies is cr ucial for ensuring a high level of health 
and safety and citizens' c onfidence in the system. Desi gnation and monitoring of 
notified bodies by the Member States, in accord ance with detailed and strict criteria, 
should therefore be subject to  controls at Union level. 
(34) 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 la boratory tests on in vitro  diagnostic medical devices to ensure 
continuous compliance by manufacturers after receipt of the orig inal certification. 
(35) For high risk in vitro  diagnostic medical devices, author ities should be informed at an 
early stage about devices which are subject to conformity assessment and be given the 
right, on scientifically va lid grounds, to scrutinise the preliminary assessment 
conducted by notified bodies, in particular  regarding devices for which no common 
technical specifications exist,  devices which are novel or for which a novel technology 
is being used, devices belonging to a cate gory of devices with increased serious 
incident rates, or devices for which sign ificant discrepancies in the conformity 
                                                 
33 OJ L 102, 23.4.2010, p. 45. 
34 OJ L 281, 23.11.1995, p. 31. 
35 OJ L 8, 12.1.2001, p. 1.  
EN 17   EN 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 confor mity assessment for a high risk in vitro  diagnostic 
medical device before submitting th e application to  the notified body. 
(36) To enhance patient safety and to take due account of technologica l progress, the risk 
classification system for in vitro  diagnostic medical device s set out in Directive 
98/79/EC should be fundamentally changed, in line with internationa l practice, and the 
corresponding conformity assessment pr ocedures should be accordingly adapted. 
(37) It is necessary, in particular for the purpos e of the conformity assessment procedures, 
to classify in vitro diagnostic medical devices into four risk classes and to establish a 
set of robust risk-based classification rule s, in line with in ternational practice. 
(38) The conformity assessment procedure for class A in vitro diagnostic medical devices 
should be carried out, as a general rule, under the so le responsibility of the 
manufacturers, since such devices pose a low risk to patients. For in vitro diagnostic 
medical devices in classes B, C and D, th e involvement of a not ified body should be 
compulsory to the appropriate degree. 
(39) The conformity assessment procedures should be further developed whilst the 
requirements for notified bodies as regard s the performance of their assessments 
should be clearly specified to ensure a level playing field. 
(40) It is necessary to clarify the requirements regarding batch release verification for the 
highest risk in vitro  diagnostic medical devices.  
(41) European Union reference laboratories should be enabled to verify  compliance of such 
devices with the applicable common tech nical specifications, when such common 
technical specifications are available, or with othe r solutions chosen by the 
manufacturer to ensure a level of safety a nd performance that is at least equivalent. 
(42) 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 evidence. 
It is necessary to clarify the requirements fo r such clinical evidence. As a general rule, 
clinical evidence should be sourced from clinical perfor mance studies to be carried out 
under the responsibility of a s ponsor who can be the manufac turer or another legal or 
natural person taking responsibility for the clinical performance study. 
(43) The rules on clinical performance studies s hould be in line with major international 
guidance, such as the international st andard ISO 14155:2011 on good clinical practice 
for clinical investigations of medical de vices for human subjects and the most recent 
(2008) version of the World Medical Association Declara tion of Helsinki on Ethical 
Principles for Medical Research Involving Human Subjects to ensure that clinical 
performance studies conducted in the Union are accepted elsewhere and that clinical performance studies conducted outside the Union in accordance with international guidelines can be accepted under this Regulation. 
(44) An electronic system should be set up at  Union level to ensure that every 
interventional clinical perf ormance studies and other cl inical performance studies 
involving risks for the subjects of the studi es are registered in a publicly accessible 
database. To protect the right to protection of personal data , recognised by Article 8 of 
the Charter of Fundamental Rights of the European Union, no personal data of 
subjects participating in a clinical perf ormance studies should be recorded in the  
EN 18   EN electronic system. To ensure synergies with  the area of clinical trials on medicinal 
products, the electronic system on c linical performance studies on in vitro  diagnostic 
medical devices should be interoperable with the EU database to be set up for clinical 
trials on medicinal products for human use.  
(45) Sponsors of interventional clinical performa nce studies and other clinical performance 
studies involving risks for the subjects 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 th e health and safety related aspects of the device for 
performance evaluation and of the scientific  design of the clinical performance study 
to be conducted in several Member Stats, su ch single application s hould facilitate the 
coordination between the Member States under the direction of a coordinating 
Member State. The coordinated assessmen t should not include the assessment of 
intrinsically national, local and ethical aspects of a clinical performance study, 
including informed consent. Each Memb er State should retain the ultimate 
responsibility for deciding whether the c linical performance study may be conducted 
on its territory. 
(46) Sponsors should report certain adverse events occu rring during interv entional c linical 
performance studies and othe r clinical performance studi es involving risks for the 
subjects to the Member States concerne d which should have the possibility to 
terminate or suspend these studies if considered necessary to ensure a high level of protection of the subjects en rolled in such studies. Such information should be 
communicated to the other Member States. 
(47) This Regulation should only cover clinical performance studies which pursue 
regulatory purposes laid down in this Regulation. 
(48) In order to better protect health and safety regarding devices on the market, the 
vigilance system for in vitro  diagnostic medical devices should be made more 
effective by creating a central portal at Union level for re porting serious incidents and 
field safety corrective actions. 
(49) 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. 
(50) 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 objective of sharing resources and ensuring consistency regarding the corrective action. 
(51) The reporting of serious adverse events dur ing interventional clinical performance 
studies and other clinical performance studi es involving risks for the subjects, and the 
reporting of serious incide nts occurring after an in vitro  diagnostic medical device has 
been placed on the market should be clea rly distinguished to avoid double reporting. 
(52) 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 19   EN (53) 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 play ing field for notified bodies. 
(54) Whilst this Regulation should not affect the ri ght of the Member Stat es 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. 
(55) An expert committee, the Medical Device Coordination Group (MDCG), composed of 
persons designated by the Member States, base d on their role and expertise in the field 
of medical devices and in vitro  diagnostic medical devices,  should be established in 
accordance with the conditions and modalities defined in Article 78 of Regulation (EU) [Ref. of future Regulation on medical devices] on medical devices
36 to fulfil the 
tasks conferred on it by this Regulation and by Regulation (EU) [Ref. of future 
Regulation on medical devices] on medical  devices, to provide advice to the 
Commission and to assist the Commission and the Member States in ensuring a 
harmonised implementation of this Regulation.  
(56) 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 uniform high level of health and safety within the 
internal market, in particular in the areas of  clinical performance studies and vigilance. 
This should also lead to more efficient use of scarce resources at national level. 
(57) The Commission should provi de scientific, technical and corresponding logistic 
support to the coordinating nati onal authority and ensure that  the regulatory system for 
in vitro  diagnostic medical devices is effectivel y implemented at Union level based on 
sound scientific evidence. 
(58) The Union should actively partic ipate in inte rnational regulatory cooperation in the 
field of in vitro  diagnostic medical devices to facili tate the exchange of safety-related 
information regarding in vitro  diagnostic medical devices and foster the further 
development of international regulatory  guidelines promoting the adoption of 
regulations in other jurisdictions with a leve l of health and safety protection equivalent 
to that set by this Regulation. 
(59) 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. 
(60) In order to maintain a high level of hea lth and safety, the power to adopt acts in 
accordance with Article 290 of the Treaty on the Functioning of the European Union 
should be delegated to the Commission in respect of the adaptation to technical 
progress of the general safety  and performance requirements, of the elements to be 
addressed in the technical documentati on, of the minimum content of the EU 
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 
                                                 
36 OJ L […], […], p. […]  
EN 20   EN approval of clinical performance studies; the establishment of the UDI system; the 
information to be submitted for the registration of in vitro diagnostic medical devices 
and certain economic operators; the level and structure of fees for the designation and 
monitoring of notified bodies; th e publicly available informa tion in respect of clinical 
performance studies; the adoption of preven tive health protection measures at EU 
level; and the tasks of and criteria for Eu ropean Union reference laboratories and the 
level and structure of fees for scie ntific 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 dele gated acts, should ensure  a simultaneous, timely and 
appropriate transmission of relevant docum ents to the European Parliament and to 
the Council. 
(61) 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 powers37.  
(62) The advisory procedure should be used for the adoption of the fo rm and presentation 
of the data elements of the manufacturers' summary of safety and performance, of the 
codes defining the notified bodies' scopes of designation and of the model for certificates of free sale, given that those acts have a procedural  character and do not 
directly impact the health and safety at Union level. 
(63) 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 whethe r a provisional national measure against 
an in vitro  diagnostic medical device presenti ng a risk or a provisional national 
preventive health protection measure is jus tified or not; and relati ng to the adoption of 
a Union measure against an in vitro  diagnostic medical de vice presenting a risk, 
imperative grounds of urgency so require.  
(64) 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 requirement s to avoid any shortage of in vitro  diagnostic 
medical devices on the market. 
(65) In order to ensure a smooth transition to the registration of in vitro  diagnostic medical 
devices, of relevant economic operators and of  certificates, the obligation to submit the 
relevant information to the electronic systems put in place by this Regulation at Union level should become fully effective only 18 mont hs after the date of application of this 
Regulation. During this transitional period, Ar ticle 10 and points (a) and (b) of Article 
12(1) of Directive 98/79/EC should remain in  force. However, economic operators and 
notified bodies who register in the relevant  electronic systems provided for at Union 
level should be considered in compliance with the registration requirements adopted 
                                                
 
37 OJ L 55, 28.2.2011, p. 13.  
EN 21   EN by the Member States pursuant to those provisions of the Directive to avoid multiple 
registrations. 
(66) Directive 98/79/EC should be repealed to en sure that only one set of rules applies to 
the placing of in vitro diagnostic medical devices on the market and the related aspects 
covered by this Regulation.  
(67) Since the objective of this Regulation, namely to ensure high standards of quality and 
safety for in vitro diagnostic medical devices, thus ensuring a high leve l of protection 
of health and safety of patients, users and other persons, ca nnot 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 ma y 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 proportional ity, as set out in that Article, this 
Regulation does not go beyond what  is necessary in order to  achieve that objective. 
HAVE ADOPTED THIS REGULATION:  
EN 22   EN Chapter I 
Scope and definitions 
Article 1 
Scope  
1. This Regulation establishes ru les to be complied with by in vitro diagnostic medical 
devices and accessories to in vitro diagnos tic medical devices that are placed on the 
market or put into service in the Union for human use. 
For the purposes of this Regulation, in vitro  diagnostic medical devices and 
accessories to in vitro  diagnostic medical devices shall hereinafter be referred to as 
'devices'. 
2. This Regulation shall not apply to:  
(a) products for general laboratory use, unl ess such products, in view of their 
characteristics, are specifically intended by their manufacturer to be used for in 
vitro  diagnostic examination; 
(b) invasive sampling devices or those whic h are directly applied to the human 
body for the purpose of obtaining a specimen; 
(c) higher metrological order reference materials. 
3. Any device which, when placed on the market or used in accordance with the 
manufacturer's instructions, incorporates as an integral part a medical device as 
defined in Article 2 of Regulation (EU)  [Ref. of future Regulation on medical 
devices] on medical devices without being an in vitro  diagnostic medical device, 
shall be governed by this Regulation, provide d that the principal intended purpose of 
the combination is that of an in vitro  diagnostic medical device referred to in Article 
2(2) of this Regulation. The relevant ge neral safety and performance requirements 
set out in Annex I to Regulation (EU) [Ref . of future Regulation on medical devices] 
shall apply as far as the safety and performa nce of the medical device part that is not 
an in vitro  diagnostic medical device are concerned. 
4. 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.  
5. This Regulation shall not affect the applic ation of Council Direct ive 96/29/Euratom, 
nor of Council Directive 97/43/Euratom. 
6. This Regulation shall not affect national la ws which require that certain devices may 
only be supplied on a medical prescription. 
7. 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  
For the purposes of this Regulation, th e following definitions shall apply:  
EN 23   EN Definitions related to devices: 
(1) ‘medical device’ means any instrument, a pparatus, appliance, software, implant, 
reagent, material or other article, 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, monitoring, treatme nt or alleviation of disease, 
– diagnosis, monitoring, treatment, allevia tion of or compensation for an injury 
or disability, 
– investigation, replacement or  modification of the anatomy or of a physiological 
process or state, 
– control or support of conception, 
– disinfection or sterilisation of a ny of the above-mentioned products,  
and which does not achieve its princi pal intended action by pharmacological, 
immunological or metabolic means, in or on the human body, but which may be 
assisted in its intended function by such means. 
(2) 'in vitro  diagnostic medical device’ means any medical device which is a reagent, 
reagent product, calibrator, control material , kit, instrument, apparatus, equipment, 
software or system, whether used alone  or in combination, intended by the 
manufacturer to be used in vitro  for the examination of specimens, including blood 
and tissue donations, derived from the hum an body, solely or principally for the 
purpose of providing information: 
– concerning a physiological or pathological state; 
– concerning a congenital abnormality; 
– concerning the predisposition to a medical condition or a disease; 
– to determine the safety and compa tibility with pote ntial recipients; 
– to predict treatment response or reactions; 
– to define or monitor therapeutic measures. 
Specimen receptacles are considered to be in vitro  diagnostic medical devices. For 
the purposes of this Regulation, ‘specimen receptacle’ means devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary 
containment and preservation of specimens  derived from the human body for the 
purpose of in vitro diagnostic examination. 
(3) 'accessory to an in vitro  diagnostic medical device' mean s an article which, whilst not 
being an in vitro  diagnostic medical device, is intended by its manufacturer to be 
used together with one or several particular in vitro  diagnostic medical device(s) to 
specifically enable or assist the in vitro  diagnostic medical devi ce(s) to be used in 
accordance with its/their intended purpose(s); 
(4)
 'device for self-testing' means any device intended by the manufacturer to be used by 
lay persons; 
(5) 'device for near-patient testing' means any device that is not intended for self-testing 
but is intended to perform testing outside a laboratory environment, generally near 
to, or at the side of, the patient;  
EN 24   EN (6) 'companion diagnostic' means a device specific ally intended to sele ct patients with a 
previously diagnosed condition or predisposi tion as eligible for a targeted therapy; 
(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 reflecting spec ific 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 several us es or prolonged use on the same patient. 
(9) 'intended purpose' means the use for which the device is intended according to the 
data supplied by the manufacturer on the labe l, in the instructions for use or in 
promotional or sales materials or statements; 
(10) 'label' means the written, printed, or gra phic information appearing either on the 
device itself, or on the packaging of each  unit, or on the packaging of multiple 
devices; 
(11) 'instructions for use' means the informa tion 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; 
(12) 'Unique Device Identification' ('UDI') mean s a series of numeric or alphanumeric 
characters that is created through intern ationally accepted device identification and 
coding standards and that al lows unambiguous identificatio n of specific devices on 
the market; 
Definitions related to the making available of devices: 
(13) 'making available on the market' means any supply of a device, other than a device 
for performance evaluation, for distribution, consumption or use on the Union market 
in the course of a commercial activity, whether in return for payment or free of charge;  
(14) 'placing on the market' means the first making available of a device, other than a 
device for performance evalua tion, on the Union market;  
(15) 'putting into service' means the stage at which a device, other than a device for 
performance evaluation, has been made available 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: 
(16) 'manufacturer' means the natural or le gal person who manufactures or fully 
refurbishes a device or has a device designed, manu factured or fully refurbished, and 
markets that device under his name or trademark.  
For the purposes of the definition of manuf acturer, fully refurbishing is defined as 
the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devi ces, to bring it in conformity with this 
Regulation, combined with the assignment of a new lifetime to the refurbished device; 
(17) 'authorised representative' means any natural or legal person established within the 
Union who has received and accepted a writte n mandate from a manufacturer to act 
on his behalf in relation to sp ecified tasks with regard to  the latter's obligations under 
this Regulation;   
EN 25   EN (18) 'importer' means any natural or legal pers on established within the Union who places 
a device from a third count ry on the Union market;  
(19) 'distributor' means any natural or legal pe rson in the supply chain, other than the 
manufacturer or the importer, who ma kes a device available on the market; 
(20) 'economic operators' means the manufactur er, the authorised representative, the 
importer and the distributor; 
(21) 'health institution' means an organisa tion whose primary purpose is the care or 
treatment of patients or the promotion of public health; 
(22) 'user' means any healthca re professional or lay person who uses a device; 
(23) 'lay person' means an individual who does not  have formal education in a relevant 
field of healthcare or medical discipline; 
Definitions related to conformity assessment: (24) 'conformity assessment' means the proce ss demonstrating whether the requirements 
of this Regulation relating to a device have been fulfilled; 
(25) 'conformity assessment body' means a body th at performs third-party conformity 
assessment activities includi ng calibration, testing, certi fication and inspection; 
(26) 'notified body' means a conformity assessme nt body designated in  accordance with 
this Regulation; 
(27) 'CE marking of conformity' or 'CE ma rking' means a marking by which the 
manufacturer indicates that  the device is in conform ity with the applicable 
requirements set out in this Regulation and other applicable Union harmonisation 
legislation providing for its affixing; 
Definitions related to clinical evidence: (28) 'clinical evidence' means the information that supports the scie ntific validity and 
performance for the use of a device as intended by the manufacturer; 
(29) 'scientific validity of an analyte' means th e association of an analyte to a clinical 
condition or a physiological state; 
(30) 'performance of a device' means the abili ty of a device to achieve its intended 
purpose as claimed by the manuf acturer. It consists of the analytical and, where 
applicable, the clinical performance suppor ting the intended purpose of the device; 
(31) 'analytical performance' means the ability of a device to correctly detect or measure a 
particular analyte; 
(32) 'clinical performance' means th e ability of a device to yiel d results that are correlated 
with a particular clinical condition or a physiological st ate in accordance with the 
target population and intended user; 
(33) 'clinical performance study’ means a study un dertaken to establish or confirm the 
clinical performance of a device; 
(34) 'clinical performance study protocol' means the document(s) setting out the rationale, 
objectives, design and proposed analys is, methodology, monitoring, conduct and 
record-keeping of the clin ical performance study; 
(35) 'performance evaluation' means the assessmen t and analysis of da ta to establish or 
verify the analytical and, where applicab le, the clinical performance of a device;  
EN 26   EN (36) 'device for performance evaluation' means a device intended by the manufacturer to 
be subject to one or more performance ev aluation studies in laboratories for medical 
analyses or in other appropriate envi ronments outside the manufacturer's own 
premises. Devices intended to be used fo r research purposes, without any medical 
objective, are not regarded as de vices for performance evaluation; 
(37) 'interventional clinical performance study'  means a clinical performance study where 
the test results may influence patient management decisions and/or may be used to guide treatment; 
(38) 'diagnostic specificity' means the ability of  a device to recognize the absence of a 
target marker associated with a particular disease or condition; 
(39) 'diagnostic sensitivity' means the ability of a device to identify the presence of a 
target marker associated with a particular disease or condition; 
(40) 'predictive value' means the probability that a person with a positive device test result 
has a given condition under investigation, or that a person with a negative device test 
result does not have a given condition; 
(41) 'positive predictive value' means the ability of a device to separate true positive 
results from false positive results for a given attribute in a given population; 
(42) 'negative predictive value' means the abilit y of a device to separate true negative 
results from false negative results for a given attribute in a given population; 
(43) 'likelihood ratio' means the likel ihood that a given result would be expected in an 
individual with the target clinical condition or physiologi cal state compared to the 
likelihood that the same result would be e xpected in an indivi dual without that 
clinical condition or physiological state; 
(44) 'calibrators and control materials' means a ny substance, material or article intended 
by the manufacturer either to establish meas urement relationships or to verify the 
performance characteristics of a device in  conjunction with the intended purpose of 
that device; 
(45) 'sponsor' means any individua l, company, institution or organisation which takes 
responsibility for the initiation and manage ment of a clinical performance study; 
(46) 'adverse event' means any untoward medical occurrence, unintended disease or injury 
or any untoward clinical signs, including an  abnormal laboratory finding, in subjects, 
users or other persons in the context of a clinical performance study, whether or not 
related to the device for performance evaluation; 
(47) 'serious adverse event' means any adverse event that led to any of the following: 
– death, 
– serious deterioration in the health of th e 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 intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function,  
EN 27   EN – foetal distress, foetal death or a congenital abnormality or birth defect. 
(48) 'device deficiency' means any inadequacy  in the identity, quality, durability, 
reliability, safety or performance of a de vice for performance evaluation, including 
malfunction, use errors or inadequacy in the information supplied by the 
manufacturer; 
Definitions related to vigila nce and market surveillance: 
(49) 'recall' means any measure aimed at achieving the return of a devi ce that has already 
been made available to the end user; 
(50) 'withdrawal' means any measure aimed at preventing a device in the supply chain 
from further being made available on the market; 
(51) '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 manufacturer and any unexpected undesirable effect; 
(52) 'serious incident' means any incident that di rectly 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 deteriorat ion of the patient's, user's or other 
person's state of health,  
– serious public health threat; 
(53) 'corrective action' means action taken to e liminate the cause of a potential or real 
non-conformity or other undesirable situation; 
(54) 'field safety corrective action' means corre ctive action taken by the manufacturer for 
technical or medical reasons to prevent or reduce the risk of a serious incident in 
relation to a device made available on the market; 
(55) 'field safety notice' means the communicatio n sent by the manuf acturer to users or 
customers in relation to a field safety corrective action; 
(56) 'market surveillance' means the activities  carried out and measures taken by public 
authorities to ensure that products comply with the requirements set out in the relevant Union harmonisation legislation a nd do not endanger health, safety or any 
other aspect of public interest protection; 
Definitions related to standards a nd other technical specifications: 
(57) ‘harmonised standard’ means a European stan dard as defined in Article 2(1)(c) of 
Regulation (EU) No [Ref. of future Re gulation on European standardisation]; 
(58) 'common technical specifications’ means a document other than a standard that 
prescribes technical requirements that pr ovide a means to comply with the legal 
obligations applicable to a device, process or system. 
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 definitions of an 
in vitro  diagnostic medical  
EN 28   EN devices or of an accessory to an in vitro  diagnostic medical device. Those 
implementing acts shall be adopted in acc ordance with the ex amination procedure 
referred to in Article 84(3). 
2. The Commission shall ensure the sharing of expertise between Member States in the 
fields of in vitro  diagnostic medical devices, 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, 
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 be based on clinical eviden ce in accordance with Article 47.  
4. Devices that are manufactured and used w ithin a single health institution shall be 
considered as being put into service. 
5. With the exception of Article 59(4), the re quirements of this Regulation shall not 
apply to devices classified as class A, B a nd C, in accordance with the rules set out in 
Annex VII, and manufactured and used onl y within a single health institution, 
provided manufacture and use occur solely  under the health institution's single 
quality management system, and the health institution is compliant with standard EN ISO 15189 or any other equivalent recognise d standard. Member States may require 
that the health institutions submit to the competent authority a list of such devices which have been manufactured and used  on their territory and may make the 
manufacture and use of the devices concerne d subject to further safety requirements. 
Devices classified as class D in accordance wi th the rules set out in Annex VII, even 
if manufactured and used within a single health institution, shall comply with the 
requirements of this Regulation. However, the provisions regarding CE marking set 
out in Article 16 and the obligations referred to in Articles 21 to 25 shall not apply to 
those devices. 
6. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 85, 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.  
EN 29   EN 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 the market but is 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 confor mity with the requirements of this 
Regulation covered by those st andards 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 plan, clinical performance studies,  clinical evidence or post-
market 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.  
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 
evidence and post-market follow-up set out in Annex XII. The CTS shall be adopted 
by means of implementing acts in accord ance with the examination procedure 
referred to in Article 84(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.  
EN 30   EN 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 85 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 the applicable requirements has been 
demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than devi ces for performance evaluation, shall draw 
up an EU declaration of conformity in accordance with Article 15 and affix the CE 
marking of conformity in  accordance with Article 16. 
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 43, 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. 
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 class and the type  of device, manufacturers of devices, other 
than devices for performance evaluation, shall institute and keep up to date a quality management system that shall addr ess 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 class and the type  of device, manufacturers of devices shall 
institute and keep up to date a systematic procedure to collect and review experience 
gained from 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 investigating complaints and reports from healthcare profe ssionals, patients or 
users on suspected incidents related to  a device, keeping a register of non- 
EN 31   EN conforming products and product recalls or w ithdrawals, and if deemed appropriate 
due to the nature of the device, sample te sting of marketed devices. Part of the post-
market surveillance plan shall be a plan for post-market follow-up in accordance with Part B of Annex XII. Where post-ma rket follow-up is not deemed necessary, 
this shall be duly justified and documente d 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 17 of Annex I in an official Union language 
which can be easily understood by the intended user. The language(s) of the information to be supplied by the manufactur er may be determined by the law of the 
Member State where the device is made available to the user.  
For devices for self-testing or near-pa tient-testing, the information supplied in 
accordance with Section 17 of Annex I shall be provided in the language(s) of the 
Member State where the device reaches its intended user. 
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 offici al 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 iden tity of that person shall be part of the 
information to be submitted in accordance with Article 23. 
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:  
EN 32   EN (a) keep the technical documen tation, the EU declaration of conformity and, if 
applicable, a copy of the relevant certif icate, including any supplement, issued 
in accordance with Article 43 at the dis posal 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. 
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 the 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;  
EN 33   EN (d) the obligation of the outgoing authorised representative after the end of the 
mandate to forward to the manufacturer or to the incoming authorised representative any complain ts or reports from health care professionals, patients 
or users about suspected incidents rela ted to a device for which he had been 
designated as authoris ed 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; 
(f) that, where applicable, a Unique Device Identification has been assigned by the 
manufacturer in accordance with Article 22. 
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 23(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.  
EN 34   EN 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 43 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 surveillance 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 43, can be 
made available to those authorities, upon request. By written mandate, the importer 
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 22 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.  
EN 35   EN 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-comp liance and of any co rrective action taken. 
5. Distributors who have receive d complaints or reports from  healthcare professionals, 
patients or users about susp ected incidents related to a device they have made 
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 the field of in vitro  diagnostic medical 
devices. 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 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 in vitro  diagnostic medical devices; 
(b) five years of professional experience in regulatory affairs or in quality 
management systems relating to in vitro  diagnostic medical devices. 
2. The qualified person shall at least be res ponsible 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 59 to 64 are fulfilled. 
(d) in the case of devices for performance evaluation intended to be used in the 
context of interventional clinical pe rformance studies or other clinical  
EN 36   EN performance studies involving risks for th e subjects, that the statement referred 
to in Section 4.1 of Annex XIII is issued; 
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 in vitro  diagnostic medical devices in the Union. 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 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 systems relating to in vitro  diagnostic medical 
devices;  
(b) five years of professional experience in regulatory affairs or in quality 
management systems relating to in vitro  diagnostic 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 device 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 applicable requirements may be affected. 
The first subparagraph shall not apply to any person who,  while not considered a 
manufacturer as defined in number (16) of Article 2, as sembles 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 17 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 37   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 27, 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 
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. 
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 85 amending or supplementing the min imum content of the EU declaration of 
conformity set out in Annex III in the light of technical progress.  
EN 38   EN Article 16 
CE marking of conformity 
1. Devices, other than devices for performa nce evaluation, considered 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 sa les 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 40. 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 17 
Devices for special purposes 
1. Member States shall not create any obsta cle to devices for performance evaluation 
which are supplied for that purpose to laborato ries or other institutions, if they meet 
the conditions laid down in Articles 48 to 58. 
2. Those devices shall not bear the CE ma rking, with the exception of the devices 
referred to in Article 52. 
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 such devices are not used on specimens taken from the 
participants and a visible si gn clearly indicates that such devices are intended for 
presentation or demonstration purposes only and cannot be made available until they 
have been made to comply with this Regulation. 
Article 18 
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;  
EN 39   EN – medical devices bearing the CE marking in conformity with Regulation (EU) 
[Ref. of future Regula tion on medical devices]; 
– 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. 
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 Anne x VIII or in Annex X. The application of 
those Annexes and the involvement of th e notified body shall be limited to the 
aspects of the procedure relating to ensuri ng sterility until the sterile package is 
opened or damaged. The person shall draw  up a statement declaring that the 
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 40. 
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 17 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 19 
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 changing its pe rformance or safety 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.  
EN 40   EN 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 20 
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. 
Chapter III 
Identification and traceability of devices, registrati on of devices 
and of economic operators, summar y of safety and performance, 
European databank on medical devices  
Article 21 
Identification within  the supply chain 
For devices, other than devices  for performance evaluation, econom ic operators shall be able 
to identify the following, for the pe riod 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 th e competent authorities thereof. 
Article 22 
Unique device identification system 
1. For devices, other than devices for perf ormance evaluation, a system for Unique 
Device Identification shall be put in place in the Union. The UDI system shall allow the identification and traceab ility 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:  
EN 41   EN (a) the entity is an organisati on with legal personality; 
(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 59. The device identifier shall appear  on the EU declaration of conformity 
referred to in Article 15 and in the techni cal documentation referred 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 85: 
(a) determining the devices, categories or groups of devices, whose identification 
shall be based on the UDI system, as set out in pa ragraphs 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; 
(b) specifying the data to be included in the production identifier which, following 
a risk-based approach, may vary depe nding 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  
EN 42   EN 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 23 
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 device for performance evaluation, 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, other than a device for performance 
evaluation, on the market, importers sha ll submit to the elec tronic 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 
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 85 amending the list of information to be submitted as set out in Part A of Annex V in the light of technical progress.  
EN 43   EN Article 24 
Summary of safety and performance 
1. In the case of devices classified as class C and D, other than devices for performance 
evaluation, the manufacturer shall draw up a summary of safety and performance. It 
shall be written in a way that is clear to the intended user. The draft of this summary shall be part of the documentation to be  submitted to the notified body involved in 
the conformity assessment in accordance w ith Article 40 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 
performance. Those implementing acts shal l be adopted in accordance with the 
advisory procedure referred  to in Article 84(2). 
Article 25 
European databank 
The Commission shall develop and manage th e European databank on medical devices 
(Eudamed) in accordance with the conditions and modalities established by Article 27 of 
Regulation (EU) [Ref. of future Regulation on medical devices].  
Eudamed shall include the follo wing as integral parts: 
(a) the electronic system on UDI referred to in Article 22;  
(b) the electronic system on registrati on of devices and economic operators 
referred to in Article 23; 
(c) the electronic system on information on certi ficates referred to in Article 43(4);  
(d) the electronic system on interventional clinical performance studies and 
clinical performance studies involving ri sks for the subjects set up in Article 
51; 
(e) the electronic system on vigilan ce referred to in Article 60; 
(f) the electronic system on market surv eillance referred to in Article 66. 
Chapter IV 
Notified Bodies 
Article 26 
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 'national author ity responsible for notified 
bodies'.  
EN 44   EN 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 interest with 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 31(3), where a national authority is responsible for the 
designation of notified bodies in th e field of products other than in vitro  diagnostic 
medical devices, the competent authority for in vitro  diagnostic medical devices shall 
be consulted on all aspects specifi cally related to such 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. 
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 27 
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 85 amending or supplementing the minimum requirements in Annex VI, in 
the light of technical progress and consid ering the minimum requi rements needed for 
the assessment of specific devices, or  categories or groups of devices  
EN 45   EN Article 28 
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 29 
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, 
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 nationa l 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 30 
Assessment of the application 
1. The national authority responsible for notifie d bodies shall check that the application 
referred to in Article 29 is complete a nd 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 Medica l Device Coordination Group ('MDCG')  
EN 46   EN referred to in Article 76. 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 expert s 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 29 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 29(2), unless the Commission repres entative mentioned in Article 30(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. 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 official 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 29 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 84(3). 
Article 31 
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.  
EN 47   EN 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 th e field of products other than in vitro  diagnostic 
medical devices, the competent authority for in vitro  diagnostic medical devices shall 
provide, prior to the notification, a positiv e 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 84(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 
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 26(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 th e 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.  
EN 48   EN Article 32 
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 31. It shall assign a 
single identification number even when the body is notified under several Union acts. 
2. The Commission shall make accessible to th e public the list of the bodies notified 
under this Regulation, including the identifi cation numbers that have been assigned 
to them and the activities for which they have been notified. The Commission shall 
ensure that the list is kept up to date. 
Article 33 
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. 
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 shal l be treated as 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 30(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.  
EN 49   EN Article 34 
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 30(2) to (6) 
and in Article 31 shall apply to changes where they entail extension of the scope of 
the notification. In all other cases, th e Commission shall immediately publish the 
amended notification in the electronic notifica tion tool referred to in Article 31(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 
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 shall 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, eith er the competent authority for in vitro  diagnostic 
medical devices of the Member State in which the manufacturer of the device 
covered by the certificate is establishe d, or another notified body responsible 
for in vitro  diagnostic medical devices confirms  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 wit hdrawal. The competent authority for in vitro  
diagnostic medical devices of the Member  State in which the manufacturer of  
EN 50   EN the device covered by the certificate is es tablished may extend the validity of 
the certificates for further periods of three months, which altogether may not 
exceed twelve months, provided it is as suming the functions 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. 
Article 35 
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  84(3). It shall notify the Member State 
concerned of its decision and update th e database and list of notified bodies. 
Article 36 
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 37 
Coordination of notified bodies 
The Commission shall ensure that appropriate  coordination and coope ration between notified 
bodies is put in place and operated in the form  of the coordination group of notified bodies 
referred to in Article 39 of Regulation [Ref. of future Re gulation on medical devices]. 
The bodies notified under this Regulation shall participate in the work of that group. 
Article 38 
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  
EN 51   EN 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 85 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 
of innovation and cost-effectivene ss. Particular attention shal l be paid to the interests 
of notified bodies that rece ived a certificate delivered  by the national accreditation 
body as referred to in Article 29(2) and not ified bodies that ar e small and medium-
sized enterprises as defined by th e Commission Recommendation 2003/361/EC38. 
Chapter V 
Classification and conformity assessment 
SECTION 1 – CLASSIFICATION  
Article 39 
Classification of in vitr o diagnostic medical devices 
1. Devices shall be divided into class A, B,  C and D, taking into account their intended 
purpose and inherent risks. Cl assification shall be carried out in accordance with the 
classification criteria 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 84(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 59 to 
73, the Commission shall be empowered to adopt delegated acts in accordance with 
Article 85 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. 
                                                
 
38 OJ L 124, 20.5.2003, p. 36  
EN 52   EN SECTION 2 – CONFORMITY ASSESSMENT  
Article 40  
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 X. 
2. Manufacturers of devices classified as cla ss D, other than devices for performance 
evaluation, shall be subject  to a conformity assessm ent based on full quality 
assurance, design dossier examination and ba tch verification, 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 production quality assu rance including batch verification, as 
specified in Annex X. 
In addition, where a reference laboratory is designated in accordance with Article 78, 
the notified body performing the conformity assessment sha ll request that reference 
laboratory to verify compliance of the de vice with the applicable CTS, when 
available, or with other solutions chosen by the manufacturer to  ensure a level of 
safety and performance that is at least equivalent, as specified in Section 5.4 of Annex VIII and in Section 3.5 of Annex IX. 
For companion diagnostics intended to be us ed to assess the pa tient eligibility for 
treatment with a specific medi cinal product, the notified body  shall consult one of the 
competent authorities designated by the Member  States in accordan ce with Directive 
2001/83/EC of the European Parliament a nd of the Council of 6 November 2001 on 
the Community code relating to medicinal products for human use
 39 or the European 
Medicines Agency (EMA) in accordance with  the procedures set out in Section 6.2 
of Annex VIII and in Section 3.6 of Annex IX. 
3. Manufacturers of devices classified as cla ss C, other than devices for performance 
evaluation, shall be subject  to a conformity assessm ent based on full quality 
assurance, as specified in Annex VIII, wi th assessment of the design documentation 
within the technical documentation on a re presentative basis. Alternatively, the 
manufacturer may choose to apply a conformity assessment based on type 
examination, as specified in Annex IX coupl ed with conformity assessment based on 
production quality assurance, as specified in Annex X. 
In addition, for devices for self-testing and near-patient tes ting, the manufacturer 
shall fulfil the supplementary requirements set out in Section 6.1 of Annex VIII or in 
Section 2 of Annex IX. 
For companion diagnostic intended to be used  to assess the pati ent eligibility to a 
treatment with a specific medi cinal product, the notified body  shall consult one of the 
competent authorities designated by the Member  States in accordan ce with Directive 
2001/83/EC or the European Medicines Ag ency (EMA) in a ccordance with the 
procedures set out in Section 6.2 of A nnex VIII and in Section 3.6 of Annex IX. 
                                                 
39 OJ L 311, 28.11.2001, p. 67.  
EN 53   EN 4. Manufacturers of devices classified as cla ss B, other than devices for performance 
evaluation, shall be subject  to a conformity assessm ent based on full quality 
assurance, as specified in Annex VIII. 
In addition, for devices for self-testing and near-patient tes ting, the manufacturer 
shall fulfil the supplementary requirement s set out in Section 6.1 of Annex VIII. 
5. Manufacturers of devices classified as cla ss A, other than devices for performance 
evaluation, shall declare the conformity  of their products by issuing the EU 
declaration of conformity referred to in  Article 15, after drawing up the technical 
documentation set out in Annex II. 
However, if the devices are intended for nea r-patient testing, or if they are placed on 
the market in sterile condition or have a measuring function, the manufacturer shall 
apply the procedures set out in Annex VIII or in Annex X. Involvement of the notified body shall be limited: 
(a) in the case of devices fo r near-patient testing, to the requirements set out in 
Section 6.1 of Annex VIII,  
(b) in the case of devices placed on the market  in sterile condition, to the aspects of 
manufacture concerned with securing  and maintaining sterile conditions, 
(c) 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. Devices for performance evaluation shall be  subject to the requirements set out in 
Articles 48 to 58. 
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. 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  Annex VIII, in the case of devices 
classified as class C; 
– 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 frequency of samples of the manufact ured devices or batches of devices 
classified as class D to be sent to  a reference laborat ory designated under 
Article 78 in accordance with Secti on 5.7 of Annex VIII and Section 5.1 of 
Annex X, or  
EN 54   EN – 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 and Sections 3.2 and 3.3 
of Annex IX. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to in Article 84(3). 
10. 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 26  to 38, 
or of the vigilance and market surveillan ce activities described in Articles 59 to 73, 
the Commission shall be empowered to a dopt delegated acts in accordance with 
Article 85 amending or supplementing the conf ormity assessment procedures set out 
in Annexes VIII to X. 
Article 41 
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 
judgment or the results of their conform ity assessment activitie s, especially as 
regards persons or groups with an intere st in the results of those activities. 
Article 42 
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 D, 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 17.3 of A nnex I and the draft 
summary of safety and performance referred to in Article 24. In its notification the 
notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall imme diately transmit the notification and the 
accompanying 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  
EN 55   EN 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)  of Regulation [Ref. of future Regulation 
on medical devices]. In its request the MDCG  shall indicate the scientifically valid 
health reason for having selected the specifi c file for submission of a summary of the 
preliminary conformity assessment. When selecting a specific file for submission, 
the principle of equal treatment shall be duly taken into account. 
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 im plementing acts, specific categories or 
groups of devices, other than de vices classified as class D, to which paragraphs 1 to 4 
shall apply during a predefin ed period of time. Those implementing acts shall be 
adopted in accordance with the examination procedure refe rred to in Article 84(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 th e impact on health in case of failure; 
(c) an increased rate of serious incidents reported in accordance with Article 59 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  
EN 56   EN to the public. It shall not disclose any pers onal data or information of commercially 
confidential nature. 
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 the 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 84(3). 
Article 43 
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 XI. 
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 en sured by appropriate corrective measures 
taken by the manufacturer within an a ppropriate deadline se t by the notified body. 
The notified body shall give th e 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 the electronic system information 
regarding certificates issued, includi ng amendments and supplements, and 
information regarding suspended, reinstate d, withdrawn or refused certificates and 
restrictions imposed on certificates. This  information shall 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 85 amending or supplementing the minimum content of the certifi cates set out in Annex XI. 
Article 44 
Voluntary change of notified body 
1. In cases where a manufacturer terminates hi s 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  
EN 57   EN defined in an agreement between the ma nufacturer, the outgoing notified body and 
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 45 
Derogation from the conform ity assessment procedures 
1. By way of derogation from Article 40, any competent authority may authorise, on 
duly justified request, the placing on the market  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 40 have not been  carried out and use of which is in 
the interest of public he alth 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 84(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 84(4). 
Article 46 
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 Regulation may be legally 
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 43 issued for the device in question.  
EN 58   EN 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 implementi ng acts shall be adopted in accordance with 
the advisory procedure refe rred to in Article 84(2). 
Chapter VI 
Clinical evidence 
Article 47 
General requirements regarding clinical evidence 
1. The demonstration of conformity with  the general safety and performance 
requirements set out in Annex I, under norma l conditions of use, shall be based on 
clinical evidence.  
2. The clinical evidence shall support the inte nded purpose of the device as stated by 
the manufacturer. 
3. The clinical evidence shall include all the information supporting the scientific 
validity of the analyte, the analytical perf ormance and, where applicable, the clinical 
performance of the device, as described in Section 1 of Part  A of Annex XII. 
4. Where demonstration of c onformity with the general safety and performance 
requirements based on clinical performan ce data or parts thereof is not deemed 
appropriate, adequate justification for any such exception shall be given based on the 
results of the manufacturer's risk mana gement and on consideration of the 
characteristics of the device and, in part icular, its intended pur pose(s), the intended 
performance and the claims of the manufact urer. The adequacy of demonstration of 
conformity with the general safety a nd performance requirements based on the 
results of analytical performance evaluati on alone shall be duly substantiated in the 
technical documentation referred to in Annex II. 
5. The scientific validity data , the analytical performance data and, where applicable, 
the clinical performance data shall be summ arised as part of a clinical evidence 
report referred to in Section 3 of Part A of Annex XII. The clinical evidence report 
shall be included or fully referenced in the technical documentation referred to in 
Annex II relating to the device concerned. 
6. The clinical evidence and its documentation shall be updated throughout the life 
cycle of the device concerned with data  obtained from implementation of the 
manufacturer's post-market surveillance plan referred to in Article 8(6).  
7. The manufacturer shall ensure  that the device for performance evaluation complies 
with the general requirements of this Regul ation apart from the aspects covered by 
the performance evaluation a nd that, with regard to t hose aspects, every precaution 
has been taken to protect the health and safe ty of the patient, user and other persons. 
The manufacturer shall undertak e to keep availabl e to the competen t authorities and 
the EU reference laboratories the docume ntation allowing an understanding of the 
design, manufacture and performances of the device, including its expected 
performance, so as to allow assessment of conformity with the requirements of this 
Regulation. This documentation shall be kept for at least five years after the performance evaluation of the device in question has ended.  
EN 59   EN Article 48 
General requirements regarding clinical performance studies 
1. Clinical performance studies shall be subject  to this Regulation if they are conducted 
for one or more of the following purposes: 
(a) to verify that, under normal conditions of use, the devices are designed, 
manufactured and packaged in such a way that they are suitable for one or more of the specific purposes of an in vitro diagnostic medical device referred 
to in number (2) of Article 2, and achieve the performance intended as 
specified by the manufacturers;  
(b) to verify that devices achieve the intended benefits to the patient as specified 
by the manufacturer; 
(c) to determine any limits to the perf ormance of the devices, under normal 
conditions of use. 
2. Clinical performance studies shall be perf ormed in circumstances similar to the 
normal conditions of use of the device. 
3. 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. 
4. All clinical performance studi es shall be designed and c onducted in a way that the 
rights, safety and well-being of the subjects participating in such clinical performance studies are protecte d and that the clinical data generated in the clinical 
performance study are going to be reliable and robust.  
5. All clinical performance st udies shall be designed, conduc ted, recorded and reported 
in accordance with Section 2 of Annex XII. 
6. For interventional clinical performance studies , as defined in numb er (37) of Article 
2, and for other clinical performance studies, wher e the conduct of the study, 
including specimen collection, involves invasive procedures or other risks for the 
subjects of the studies, the requirements set out in Articles 49 to 58 and in Annex 
XIII shall apply, in addition to the obligations laid down in this Article. 
Article 49 
Application for interventional clinical perfor mance studies and other clinical performance 
studies involving risks for the subjects of the studies 
1. Before making the first application, the sponsor shall procure from the electronic 
system referred to in Article 51 a single identification number for a clinical performance study conducted in one site or multiple sites, in one or more than one Member State. The sponsor shall use th is single identificat ion number when 
registering the clinical performance study in accordance with Article 50. 
2. The sponsor of a clinical performance study shall subm it an application to the 
Member State(s) in which the study is to be conducted accompanied by the documentation referred to in Annex XIII. Within six days after receipt of the 
application, the Member State concerned shall notify the sponsor whether the clinical  
EN 60   EN performance study 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 performance study shall be considered as 
falling within the scope of this Regulation and the application sh all be considered 
complete. 
3. Where the Member State finds that the c linical performance study 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 performance study sh all be considered as fallin g 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 performance study in the following circumstances:  
(a) in the case of devices for performance eval uation classified as  class C or D, as 
soon as the Member State concerned has notified the sponsor of its approval; 
(b) in the case of devices for performance evaluation classified as class A or B 
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 performance study 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 
study site(s) and the investigators involved, as we ll as free of any other undue 
influence.  
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 85 amending or supplementing, in th e light of technical progress and global 
regulatory developments, the requirements for the documentation to be submitted  
EN 61   EN with the application for the clinical perfor mance study that is laid down in Chapter I 
of Annex XIII. 
Article 50  
Registration of interventional clinical perfor mance studies and other clinical performance 
studies involving risks for the subjects of the studies 
1. Before commencing the clinical performan ce study, the sponsor shall enter in the 
electronic system referred to in Articl e 51 the following information regarding the 
clinical performance study: 
(a) the single identificati on number of the clinical performance study; 
(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 device for performa nce evaluation, if different from the 
sponsor; 
(d) the description of the device for performance evaluation; 
(e) the description of the comp arator(s), if applicable; 
(f) the purpose of the clinic al performance study; 
(g) the status of the clin ical performance study. 
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 51. 
3. The information shall be accessible to th e public, through the electronic system 
referred to in Article 51, 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 the conduct of the clinical  performance study by the 
Member State(s) concerned. 
4. No personal data of subjects participating in the clinical perf ormance study shall be 
accessible to the public. 
Article 51 
Electronic system on interven tional clinical performance studies and other clinical 
performance studies involving risks for the subjects of the studies 
1. The Commission shall, in collaboration w ith the Member States, set up and manage 
an electronic system on interv entional clinical performan ce studies and other clinical 
performance studies involving risks for the subj ects of the studies to create the single 
identification numbers for such clinical pe rformance studies referred to in Article 
49(1) and to collate and pro cess the following information: 
(a) the registration of clinical performan ce studies in accordance with Article 50;  
EN 62   EN (b) the exchange of information between th e Member States and between them and 
the Commission in accordance with Article 54; 
(c) the information related to clinical perf ormance studies conducted in more than 
one Member State in case of a single app lication in accordance with Article 56; 
(d) the reports on serious adverse events a nd device deficiencies referred to in 
Article 57(2) in case of single app lication in accordance with Article 56. 
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 
[Ref. of future Regulation on clinical trials]. With the exception of the information referred to in Article 50, the information collated and processed in the electronic 
system shall 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 85 determining which other information regarding clinical performance studies 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  [Ref. of future Regulation on clinical 
trials]. Article 50(3)  and (4) shall apply. 
Article 52 
Interventional clinical performance studies and other clinical performance studies involving 
risks for the subjects of the studies with devices authoris ed to bear the CE marking 
1. Where a clinical performance study is to  be conducted to fu rther assess devices 
which are authorised in accordance with Article 40 to bear the CE marking and 
within its intended purpose referred to in the relevant conformity assessment procedure, hereinafter referred to as ‘ post-market follow-up performance study’, the 
sponsor shall notify the Memb er States concerned at le ast 30 days prior to their 
commencement if the study would submit subjects to additionally invasive or burdensome procedures. Articles 48(1) to  (5), 50, 53, 54(1) an d 55(1), the first 
subparagraph of Article 55(2)  and the relevant provision s of Annexes XII and XIII 
shall apply. 
2. If the aim of the clinical performance study regarding a device which is authorised in 
accordance with Article 40 to bear the CE marking is to  assess such device for a 
purpose other than that referred to in the information supplied by the manufacturer in 
accordance with Section 17 of Annex I and in the relevant conformity assessment 
procedure, Articles 48 to 58 shall apply. 
Article 53 
Substantial modifications to interventional clin ical performance studies and other clinical 
performance studies involving risks for the subjects of the studies 
1. If the sponsor introduces modifications to a clinical performan ce study 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 da ta generated by the st udy, 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 Annex XIII.  
EN 63   EN 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 54 
Information exchange between Memb er States on interventional clinical performance studies 
and other clinical performance studies involv ing risks for the subjects of the studies 
1. Where a Member State has refused, suspende d or terminated a clinical performance 
study, or has called for a substantial modifi cation or temporary halt of a clinical 
performance study, or has been notified by th e sponsor of the early termination of a 
clinical performan ce study 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 51. 
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 51. 
Article 55 
Information by the sponsor in the event of temporary halt or termination of interventional 
clinical performance studies or of other clinical performance studies involving risks for the 
subjects of the studies 
1. If the sponsor has temporarily halted a c linical performance study on safety grounds, 
he shall inform the Member States concer ned within 15 days of the temporary halt. 
2. The sponsor shall notify each Member Stat e concerned of the end of a clinical 
performance study in relation to  that Member State, provi ding a justific ation in the 
event of early termination. Th at notification shall be made within 15 days from the 
end of the clinical performance study in relation to that Member State. 
If the study is conducted in more than one Member State, the sponsor shall notify all 
Member States concerned of the overall e nd of the clinical performance study. That 
notification shall be made within 15 days  from the overall end of the clinical 
performance study. 
3. Within one year from the end of the c linical performance study, the sponsor shall 
submit to the Member States concerned a summary of the results of the clinical performance study in form of a clinical  performance study report referred to in 
Section 2.3.3 of Part A of Anne x XII. Where, for scientific  reasons, it is not possible 
to submit the clinical performance study re port within one year, it shall be submitted 
as soon as it is available. In this case,  the clinical performance study protocol 
referred to in Section 2.3.2 of Part A of A nnex XII shall specify when the results of 
the clinical performance st udy are going to be subm itted, together with an 
explanation.   
EN 64   EN Article 56 
Interventional clinical performance studies and other clinical performance studies involving 
risks for the subjects of the studies conducted in more than one Member State 
1. By means of the electronic system referre d to in Article 51, the sponsor of the 
clinical performance study to be conducte d in more than one Member State may 
submit, for the purpose of Article 49, a si ngle application 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 lines referred to in Article 49(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 I of Annex XIII, except for Sections 4.2, 4.3 and 4.4 thereo f 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 performance study falls within  the scope of this Regulation and 
whether the application is complete, except for the documentation submitted in accordance with Sections 4.2, 4.3 and 4.4 of  Chapter I of Annex XIII for which 
each Member State shall verify the comp leteness. Article 49(2) to (4) shall 
apply to the coordinating Member State in  relation to the verification that the 
clinical performance study falls within th e scope of this Regulation and that the 
application is complete, except for the documentation submitted in accordance 
with Sections 4.2, 4.3 and 4.4 of Chapter I of Annex XIII. Article 49(2) to (4) shall apply to each Member State in relation to the verification that the 
documentation submitted in accordance with Sections 4.2, 4.3 and 4.4 of Chapter I of Annex XIII is complete; 
(b) establish the results of the coordinated assessment in a report to be taken into 
account by the other Member  States concerned when deciding on the sponsor's 
application in accordance with Article 49(5). 
4. The substantial modifications referred to in Article 53 shall be notified to the 
Member States concerned by means of the el ectronic system referred to in Article 51. 
Any assessment as to whether there are groun ds for refusal as referred to in Article 
53 shall be carried out under the direc tion of the coordinating Member State. 
5. For the purpose of Article 55 (3), the sponsor shall subm it the clinical  performance 
study report to the Member States concer ned by means of the electronic system 
referred to in Article 51. 
6. The Commission shall provide secretarial s upport to the coordinating Member State 
in the accomplishment of its tasks provided for in this Chapter.  
EN 65   EN Article 57 
Recording and reporting of events occurring dur ing interventional clinical performance 
studies and other clinical performance studies in volving risks for the subjects of the studies 
1. The sponsor shall fully record any of the following: 
(a) an adverse event identified in the clinical  performance study protocol as critical 
to the evaluation of the results of the c linical performance st udy in view of the 
purposes referred to in Article 48(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 St ates where a clinical performance study is 
conducted without delay any of the following: 
(a) a serious adverse event that has a cau sal relationship with the device for 
performance evaluation, the comparator or the study procedur e 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. 
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 performance study is 
performed under the same clinical performa nce study protocol as the one applying to 
a clinical performance study covered by this Regulation. 
4. In the case of a clinical pe rformance study for which the sponsor has used the single 
application referred to in Article 56, the s ponsor shall report any event as referred to 
in paragraph 2 by means of the electroni c system referred to in Article 51. 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 56(2), the 
Member States shall coordinate their assessm ent of serious adverse events and device 
deficiencies to determine whether a c linical performance study needs to be 
terminated, suspended, tempor arily 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.  
EN 66   EN 5. In the case of post-market follow-up performa nce studies referred to in Article 52(1), 
the provisions on vigilance contained in Artic les 59 to 64 shall apply instead of this 
Article. 
Article 58 
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 for clinical performance studies and their 
assessment as referred to in Articles 49 and 56, taking into account specific categories or groups of devices; 
(b) the functioning of the electronic sy stem referred to in Article 51; 
(c) harmonised forms for the notification of post-market follow-up performance 
studies as referred to in Article 52(1),  and of substantial modifications as 
referred to in Article 53; 
(d) the exchange of information between Memb er States as referred to in Article 
54; 
(e) harmonised forms for the reporting of serious adverse events and device 
deficiencies as referr ed to in Article 57; 
(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 57. 
Those implementing acts shall be adopted in  accordance with the examination procedure 
referred to in Article 84(3). 
Chapter VII 
Vigilance and market surveillance 
SECTION 1 — VIGILANCE  
Article 59 
Reporting of incidents and field  safety corrective actions 
1. Manufacturers of devices, other than devices  for performance evaluation, shall report 
through the electroni c system referred to in Article 60 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  
EN 67   EN possible. The time period for reporting shal l take account of the severity of the 
incident. Where necessary to ensure timel y reporting, the manufacturer 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 60(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 necessa ry 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. 
4. Health institutions manufacturing and using devices referred to in  Article 4(4) shall 
report any serious incidents and field sa fety corrective actions referred to in 
paragraph 1 to the competent authority of  the Member State in which the health 
institution is located. 
Article 60 
Electronic system on vigilance  
1. The Commission shall, in collaboration w ith the Member States, set up and manage 
an electronic system to collate and process the following information: 
(a) the reports by manufacturers  on serious incidents an d field safety corrective 
actions referred to in Article 59(1); 
(b) the periodic summary reports by manufact urers referred to in Article 59(2); 
(c) the reports by competent au thorities on serious incidents referred to in the 
second subparagraph of Article 61(1); 
(d) the reports by manufacturers on tren ds referred to in Article 62; 
(e) the field safety notices by manufactur ers referred to in Article 61(4); 
(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 61(3) and (6). 
2. The information collated and processed by the electronic system shall be accessible 
to the competent authorities of the Memb er 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.   
EN 68   EN 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 59(1), the period ic summary reports referred to in Article 
59(2), the reports on serious incidents referred to in the second subparagraph of 
Article 61(1) and the trend re ports referred to in Article 62 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; 
(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 43 for the device in question, is 
established. 
Article 61 
Analysis of serious incidents and field safety corrective action  
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 59 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 59(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 60, 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 m onitor the manufacturer's inve stigation of the incident. 
3. After carrying out the assessment, the evaluating competent authority shall, through 
the electronic system referred to in Artic le 60, inform without delay the other 
competent authorities of the corrective acti on taken or envisaged by the manufacturer 
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.  
EN 69   EN 4. 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 5 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 60 through which that no tice shall be accessi ble to the public. 
5. 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 device  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. 
6. The coordinating competent authority sh all carry out the following 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 43 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 60(5) on the format, content and frequency of periodic summary reports in accordance with Article 59(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  60, of the progress in and the outcome 
of its assessment. 
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.  
7. 
The Commission shall provide secretarial support to the coordinating competent 
authority in the accomplishment of its tasks under this Chapter.   
EN 70   EN Article 62 
Trend reporting 
Manufacturers of devices classifi ed in class C or D shall repor t to the electronic system 
referred to in Article 60 any stat istically significant increase in the frequency or severity of 
incidents that are not serious incidents or of expected undesirable 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 effects in respect of th e device, or category or  group of devices, in 
question during a specific time period as es tablished in the manufacturer’s conformity 
assessment. Article 61 shall apply. 
Article 63 
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 59, tr end reports referred to 
in Article 62 and field safety notices referred to in Article 61(4). 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 64 
Implementing acts 
The Commission may, by means of implementing acts, adopt the modalities and procedural 
aspects necessary for the implementation of Articles 59 to 63 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 59 and 62;  
(c) timelines for the reporting of serious incidents and field safety corrective 
actions, periodic summary reports and trend reports by manufacturers, taking into account the severity of the event to be reported as referred to in Articles 59 and 62; 
(d) harmonised forms for the exchange of information between competent 
authorities as referre d to in Article 61. 
Those implementing acts shall be adopted in  accordance with the examination procedure 
referred to in Article 84(3).  
EN 71   EN SECTION 2 — MARKET SURVEILLANCE  
Article 65 
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 availabl e the documentation and info rmation 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 accessibl e 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 66 
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: 
(a) information in relation to non-compliant de vices presenting a ri sk to health and 
safety referred to in Article 68(2), (4) and (6); 
(b) information in relation to compliant devices presenting a risk to health and 
safety referred to in Article 70(2); 
(c) information in relation to formal non-compliance of products referred to in 
Article 71(2); 
(d) information in relation to preventive hea lth protection measures referred to in 
Article 72(2).  
EN 72   EN 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 67 
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 68 
Procedure for dealing with non-compliant devi ces presenting a risk to health and safety  
1. Where, having performed an evaluation pursuant to Article 67, 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 
66. 
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. 
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 prohi bit 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 66. 
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.   
EN 73   EN 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 66. 
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 69  
Procedure at Union level 
1. Where, within two months of receipt of th e notification referred to in Article 68(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 84(3). 
2. If the national measure is considered justified, Article 68(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 68 and 70, 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 
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 84(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 84(4). 
Article 70 
Procedure for dealing with compliant devices presenting a risk to health and safety 
1. Where, having performed an evaluation pursu ant to Article 67, 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  
EN 74   EN 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 
66. 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 
84(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 84(4).  
4. Where the national measure is considered justified, Article 68(8) shall apply. If the 
national measure is considered unjustified, the Member State concerned shall 
withdraw the measure. 
Article 71 
Formal non-compliance 
1. Without prejudice to Article 68, 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:  
(a) that the CE marking has been affixed in  violation of the formal requirements 
laid down in Article 16; 
(b) that the CE marking has not been affixe d to a device contrary to Article 16; 
(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 66.  
EN 75   EN Article 72 
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 66. 
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 84(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 84(4). 
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 85 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 86 shall apply to delegated acts adopted pursuant to this paragraph. 
Article 73 
Good administrative practice 
1. Any measure adopted by the competent author ities of the Member States pursuant to 
Articles 68 to 72 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 sh all be given the opportunity to make  
EN 76   EN 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 68 to 72 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 74 
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 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 48 to 58, 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 75 
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 76 
Medical Device Coordination Group 
The Medical Device Coordination Group (MDC G) established in accordance with the 
conditions and modalities defined in Article 78 of  Regulation (EU) [Ref. of future Regulation 
on medical devices] shall carry out, with the s upport of the Commission as provided in Article 
79 of that Regulation, the tasks assigned to it by this Regulation.  
Article 77  
Tasks of the MDCG 
The MDCG shall have the following tasks:  
EN 77   EN (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 42; 
(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; 
(d) to assist the competent authorities of the Member States in their coordination 
activities in the fields of clinical pe rformance studies, 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 in vitro  
diagnostic medical devices in the Member States. 
Article 78 
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 verify compliance of class D devices with the applicable CTS, when 
available, or with other solutions chosen  by the manufacturer to ensure a level 
of safety and performance that is at least equivale nt, as provided for in the 
second subparagraph of Article 40(2); 
(b) to carry out appropriate tests on samples of manufactured class D devices or 
batches of class D devices, as provided  for in the Section 5.7 of Annex VIII 
and in Section 5.1 of Annex X; 
(c) to provide scientific and technical a ssistance to the Commission, the Member 
States and notified bodies in relation to the implementation of this Regulation; 
(d) to provide scientific advice regarding the state of the art in relation to specific 
devices, or a category or group of devices; 
(e) 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; 
(f) to contribute to the development of appr opriate testing and an alysis methods to 
be applied for conformity assessment procedures and market surveillance;  
EN 78   EN (g) to collaborate with notifie d bodies in the development of best practices for the 
performance of conformity assessment procedures; 
(h) to provide recommendations on suitabl e reference materials and reference 
measurement procedures of higher metrological order;  
(i) to contribute to the development of  standards at international level; 
(j) 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 in vitro  diagnostic medical devices for which they are 
designated; 
(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; 
(f) to act in the public interest and in an independent manner; 
(g) to ensure that their staff do not have financial or other interests in the in vitro  
diagnostic medical device industry whic h could affect their impartiality, 
declare any other direct and indirect  interests they may have in the in vitro  
diagnostic medical device industry and update this declaration whenever a 
relevant change occurs. 
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 84(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 85 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  
EN 79   EN 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 79 
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 80 
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, investig ations 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. 
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.  
EN 80   EN Article 81 
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 82 
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 83 
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 shall 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 this Regulation] and sha ll notify it without delay of any subsequent 
amendment affecting them. 
Chapter X 
Final provisions  
Article 84 
Committee procedure 
1. The Commission shall be assisted by th e Committee on Medical Devices set up by 
Article 88 of Regulation (E U) [Ref. of future Regulation on medical devices]. 
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. 
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 85 
Exercise of the delegation 
1. The power to adopt the delegated acts referr ed to in Articles 4( 6), 8(2), 15(4), 22(7), 
23(7), 27(2), 38(2), 39(4), 40( 10), 43(5), 49(7), 51(3), 72(4)  and 78(6) is conferred 
on the Commission subject to the cond itions laid down in this Article.  
EN 81   EN 2. The delegation of power referred to in Artic les 4(6), 8(2), 15(4), 22(7), 23(7), 27(2), 
38(2), 39(4), 40(10), 43(5), 49(7), 51(3), 72( 4) and 78(6) shall be conferred on the 
Commission for an indeterminate period of tim e from the date of entry into force of 
this Regulation. 
3. The delegation of power referred to in Artic les 4(6), 8(2), 15(4), 22(7), 23(7), 27(2), 
38(2), 39(4), 40(10), 43(5), 49(7), 51(3), 72( 4) and 78(6) may be revoked at any time 
by the European Parliament or by the Counc il. 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 86 
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 85. 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.  
Article 87 
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 with  Directive 98/79/EC shall become void.  
2. Certificates issued by notified bodies in accordance with Directive 98/79/EC prior to 
the entry into force of this Regulation sh all remain valid until the end of the period 
indicated on the certificate, except for certificates issued  in accordance with Annex 
VI of Directive 98/79/EC 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 Directive 98/79/EC after the 
entry into force of this Regulation shall b ecome void at the latest two years after the 
date of application of this Regulation.   
EN 82   EN 3. By way of derogation from Directive 98/79/EC, devices which comply with this 
Regulation may be placed on the market before its date of application.  
4. By way of derogation from Directive 98/79 /EC, conformity assessment bodies which 
comply with this Regulation may be design ated and notified before its date of 
application. Notified bodies which are designated a nd notified in accordance with 
this Regulation may apply the conformity a ssessment 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 10 and points (a) and (b) of Article 12(1) of 
Directive 98/79/EC, manufacturers, auth orised representatives, importers and 
notified bodies who, during the period from [date of applicati on] until [18 months 
after date of application], comply with Article 23(2) and (3) and Article 43(4) of this Regulation shall be considered to comply with the laws and regulations adopted by 
Member States in accordance with Article 10 and points (a) and (b) of Article 12(1) 
of Directive 98/79/EC as specified  in Commission D ecision 2010/227/EU. 
6. Authorisations granted by competent author ities of the Member States in accordance 
with Article 9(12) of Directive 98/79/EC shall keep the validity indicated in the 
authorisation.  
Article 88 
Evaluation 
No later than five years after the date of  application, the Comm ission shall assess the 
application of this Regulation and establish an evaluation report on the progress towards 
achievement of the objectives of this Regul ation including an assessment of resources 
required to implement this Regulation.  
Article 89 
Repeal 
Directive 98/79/EC of the European Parliament  and of the Council is repealed with effect 
from [date of application of this Regulation] with the excep tion of Article 10 and points (a) 
and (b) of Article 12(1) of Directive 98/79/EC  which are repealed with effect from [18 
months after date of application]. 
References to the repealed Directive shall be understood as reference to this Regulation and 
shall be read in accordance with the co rrelation table laid down in Annex XIV. 
Article 90 
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 [five years after entry into force]. 
3. By way of derogation from paragr aph 2, the following shall apply: 
(a) Article 23(2) and (3) and Article 43(4) sh all apply from [18 months after date 
of application referred to in paragraph 2];  
EN 83   EN (b) Articles 26 to 38 shall apply from [six m onths after entry into force]. However, 
prior to [date of application as referred  to in paragraph 2] , the obligations on 
notified bodies emanating fr om the provisions in Articles 26 to 38 shall apply 
only to those bodies which submit an app lication for notifica tion in accordance 
with Article 29 of this Regulation.  
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 26.9.2012 
For the European Parliament For the Council 
The President The President  
EN 84   EN ANNEXES   
I General safety and performance requirements 
II Technical documentation  III EU Declaration of conformity  IV CE marking of conformity  V Information to be submitted with the regi stration of devices and economic operators 
in accordance with Article 23 and data el ements of the UDI device identifier in 
accordance with Article 22 
VI Minimum requirements to be met by Notified Bodies  VII Classification criteria  VIII Conformity assessment based on full quality assurance and design examination  IX Conformity assessment based on type examination  X Conformity assessment based on production qual ity assurance 
XI Minimum content of certificates issued by a notified body  XII Clinical evidence and post-market follow-up XIII Interventional clinical performance st udies and other clinical performance studies 
involving risks for the subjects of the studies 
XIV Correlation table  
EN 85   EN ANNEX I  
GENERAL  SAFETY  AND  PERFORMANCE  REQUIREMENTS   
I. GENERAL REQUIREMENTS  
1. The devices shall achieve the performan ce intended by the manufacturer and be 
designed and manufactured in such a way that, dur ing normal conditio ns of use, they 
are suitable for their intended purpos e, taking into account the generally 
acknowledged state of the art. They shall not  compromise, directly or indirectly, the 
clinical condition or the safety of the patients, or the safety or health of users or, where applicable, other persons, provided th at any risks or lim its to performance 
which may be associated with their use c onstitute 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 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 tec hnical knowledge, experience,  education or 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 
applies for the lifetime reasonably to be expected of a device of that kind, having 
regard to the intended purpose and the anticipated use of the device. 
4. The devices shall be designed, manufactured and packaged in such a way that their 
characteristics and performance during their intended use will not be adversely affected by transport and storage conditions (f or example, fluctuations of temperature  
EN 86   EN and humidity) taking account of the instru ctions and information provided by the 
manufacturer. 
5. All known and foreseeable risks, and any unde sirable effects, shall be minimised and 
be acceptable when weighed against the benefits to the patients of the intended performance of the device during normal conditions of use.  
II.
 REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION  
6. Performance characteristics 
6.1. The devices shall be designed and manufactur ed in such a way th at the performance 
characteristics support the intended purpose,  based on appropria te scientific and 
technical methods. They shall achieve the performances, as stated by the 
manufacturer and in particular, where appropriate: 
(a) the analytical performance, such as accuracy (trueness and precision), 
bias, analytical sensitivity, analytical  specificity, limits of detection and 
quantitation, measuring range, lin earity, cut-off, repeatability, 
reproducibility, including determina tion of appropriate criteria for 
specimen collection and handling a nd control of known relevant 
endogenous and exogenous interfer ence, cross-reactions; and  
(b) the clinical performance, such as  diagnostic sensi tivity, diagnostic 
specificity, positive and negative pr edictive value, likelihood ratio, 
expected values in normal or affected populations. 
6.2. The performance characteristics of the device need to be maintained during the 
lifetime of the device as i ndicated by the manufacturer. 
6.3. Where the performance of devices depends on the use of calibrators and/or control 
materials, the metrological traceability of va lues assigned for a given analyte to such 
calibrators and/or co ntrol materials shall be assured through availabl e and suitable 
reference measurement procedures and/or av ailable and suitable reference materials 
of a higher metrological order. The devi ce shall be designed and manufactured to 
enable the user to provide measurement results in patient specimens metrologically traceable to available and suitable higher or der reference materials and/or reference 
measurement procedures following the inst ructions and information provided by the 
manufacturer. 
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 the possibility of impairment of analytical 
performance due to incompatibility between the materials used and the specimens and/or analyte to be detected (such as biological tissues, cells, body fluids and micro-
organisms), taking account of th e intended purpose of the device. 
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.  
EN 87   EN 7.3. The devices shall be designed and manufactured  in such a way as to reduce as far as 
possible the risks posed by s ubstances that may leach or leak from the device. 
Special attention shall be given to substa nces which are carcinogenic, mutagenic or 
toxic to reproduction, in accordance with Part  3 of Annex VI to Regulation (EC) No 
1272/2008 of the European Parliament a nd of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/ 45/EC, and amending Regulation (EC) 
No 1907/2006
40, and to substances having endocrine disrupting properties for which 
there is scientific evidence of probable seri ous effects to human health and which are 
identified in accordance with the procedur e set out in Article 59 of Regulation (EC) 
No 1907/2006 of the European Parliament a nd of the Council of 18 December 2006 
concerning the Registration, Evaluation, Aut horisation and Restriction of Chemicals 
(REACH)41 . 
7.4. The devices shall be designed and manufactured  in such a way as to reduce as far as 
possible the risks posed by the unintentional in gress or egress of substances into or 
from the device, taking into account the de vice and the nature of  the environment in 
which it is intended to be used. 
8. Infection and microbial contamination 
8.1. The devices and their manufacturing processes shall be designed in such a way as to 
eliminate or reduce as far as possible the risk  of infection to the user, professional or 
lay, or, where applicable, other persons. 
The design shall: (a) allow easy and safe 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. The devices labelled either as sterile or as  having a special microbiological state shall 
be designed, manufactured and packaged to ensure that they remain so when placed 
on the market, and remain so under the tr ansport and storage conditions specified by 
the manufacturer, until the protectiv e packaging is damaged or opened. 
8.3. The devices labelled either as sterile or as  having a special microbiological state shall 
have been processed, manufactured and, if applicable, sterilised by appropriate 
validated methods. 
8.4. The devices intended to be sterilised shall be manufactured in appropriately 
controlled (e.g. environmental) conditions. 
8.5. Packaging systems for non-sterile devices shall maintain the integrity and cleanliness 
of the device indicated by th e manufacturer and, if the devi ces are to be sterilised 
prior to use, minimise the risk of micr obial contamination; the packaging system 
shall be suitable taking account of the method of sterilisatio n indicated by the 
manufacturer. 
                                                
 
40 OJ L 353, 31.12.2008, p. 1. 
41 OJ L 136, 29.5.2007, p.3.  
EN 88   EN 8.6. The labelling of the devices shall distinguish between id entical or similar products 
placed on the market in both ster ile and non-sterile condition. 
9. Devices incorporating materi als of biological origin 
9.1. Where the devices include tissues, cells and substances originating from animals, the 
processing, preservation, testi ng and handling of tissues, cells and substances of such 
origin shall be carried out so as to provi de optimal safety for user, professional or 
lay, or other person. 
In particular, safety with regard to viru ses and other transmissi ble agents shall be 
addressed by implementation of  validated methods of elimination or inactivation in 
the course of the manufacturing process. This  may not apply to ce rtain devices if the 
activity of the virus and other transmissibl e agent are integral to the intended purpose 
of the device or when such elimination or inactivation proce ss would compromise 
the performance of the device. 
9.2. Where the devices include human tissues, cells or substances , the selection of 
sources, donors and/or substances of hu man origin, the processing, preservation, 
testing and handling of tissues, cells and subs tances of such origin shall be carried 
out so as to provide optimal safety for user, professional or lay, or other person. 
In particular, safety with regard to viru ses and other transmissi ble agents shall be 
addressed by implementation of  validated methods of elimination or inactivation in 
the course of the manufacturing process. This  may not apply to ce rtain devices if the 
activity of the virus and other transmissibl e agent are integral to the intended purpose 
of the device or when such elimination or inactivation proce ss would compromise 
the performance of the device. 
9.3. Where the devices include cells or substa nces of microbial or igin, the processing, 
preservation, testing and handlin g of cells and substances sha ll be carried out so as to 
provide optimal safety for user, pr ofessional or lay, or other person. 
In particular, safety with regard to viru ses and other transmissi ble agents shall be 
addressed by implementation of  validated methods of elimination or inactivation in 
the course of the manufacturing process. This  may not apply to ce rtain devices if the 
activity of the virus and other transmissibl e agent are integral to the intended purpose 
of the device or when such elimination or inactivation proce ss would compromise 
the performance of the device. 
10. Interaction of devices with their environment 
10.1. 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 performances of the devices. Any restricti ons on use applying to 
such combinations shall be indicated on the label and/or in the instructions for use. 
Connections which the user has to handle sh all be designed and constructed in such a 
way as to minimise all possible risks from incorrect connection. 
10.2. The devices shall be designe d and manufactured in such  a way as to remove or 
reduce as far as possible and appropriate: 
(a) the risks of injury to us er, professional or lay, or  other person in connection 
with their physical and ergonomic features; 
(b) the risks of use error due to the er gonomic features, human factors and the 
environment in which the device is intended to be used;   
EN 89   EN (c) the risks connected with any foreseeable external influences or environmental 
conditions, such as magnetic fields, ex ternal electrical and electromagnetic 
effects, electrostatic discharge, pressu re, humidity, temperature variations 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 risks associated with the possible ne gative interaction between software and 
the environment within which it operates and interacts; 
(f) the risks of accidental ingress of  substances into the device; 
(g) the risk of incorrect identification of specimens; 
(h) the risks of any foreseeable in terference with other devices. 
10.3. The devices shall be designed and manufactur ed in such a way as to minimise the 
risks of fire or explosion during normal us e and 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. 
10.4. The devices shall be designed and manufact ured in such a way that adjustment, 
calibration, and maintenance, where such is  necessary to achieve the performances 
intended, can be done safely. 
10.5. The devices that are intended to be operate d together with other devices or products 
shall be designed and manufactured in such as way that the interoperability is reliable 
and safe. 
10.6. The devices shall be designed and manufactur ed in such a way as to facilitate the 
safe disposal of the device and/or of any waste substances by the user, professional 
or lay, or other person. 
10.7. The measuring, monitoring or display scal e (including colour change and other 
visual indicators) shall be designed and manufactured in line with ergonomic 
principles, taking account of the intended purpose of the device. 
11. Devices with a measuring function 
11.1. The devices having a primary analytical measuring function sh all be designed and 
manufactured in such a way as to provide sufficient accuracy, precision and stability 
of measurement within appr opriate accuracy limits, taki ng into account the intended 
purpose of the device and of available and appropriate reference measurement 
procedures and materials. The accuracy lim its shall be specified by the manufacturer. 
11.2. 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/EEC42. 
12. Protection against radiation 
12.1. The devices shall be designed, manufactured  and packaged in such a way that 
exposure of user, professional or lay, or  other persons to the emitted radiation 
(intended, unintended, stray or scattered) is reduce d as far as possible. 
                                                 
42 OJ L 39, 15.2.1980.  
EN 90   EN 12.2. When the devices are intended to emit potentia lly hazardous, visible and/or invisible 
radiation, they shall as  far as possible be:  
(a) designed and manufactured in such a way as  to ensure that the characteristics 
and the quantity of radiation emitted can  be controlled and/or adjusted; and 
(b) fitted with visual displays and/or audible warnings of such emissions. 
12.3. The operating instructions for devices emitting radiation shall give detailed 
information as to the nature of the emitte d radiation, means of protecting the user, 
and on ways of avoiding misuse and of elim inating the risks inherent in installation. 
13. Software incorporated in devices and standalone software 
13.1. The devices that incorporate electronic programmable systems, including software, 
or standalone software that are devices in  themselves, shall be  designed to ensure 
repeatability, reliability and performance according to the inte nded purpose. In the 
event of a single fault conditi on, appropriate means shall be  adopted to eliminate or 
reduce as far as possible and a ppropriate consequent risks. 
13.2. For the devices that incorporate software or  for standalone softwa re that are devices 
in themselves, the software shall be de veloped and manufactured according to the 
state of the art taking into account the prin ciples of development life cycle, risk 
management, verification and validation. 
13.3. 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). 
14. Devices connected to or equipped with an energy source 
14.1. For the devices connected to or equipped w ith an energy source, in the event of a 
single fault condition, appropriate means sha ll be adopted to elim inate or reduce as 
far as possible and appropriate consequent risks. 
14.2. The devices where the safety of the patient depends on an  internal power supply in 
the device shall be equipped with a means of determining the state of the power 
supply. 
14.3. The devices shall be designed and manufactured  in such a way as to reduce as far as 
possible the risks of creating electromagne tic interference which could impair the 
operation of this or other devices or equipment in the intended environment. 
14.4. The devices shall be designed and manufact ured in such a way as to provide an 
adequate level of intrinsic immunity to elec tromagnetic disturbance to enable them to 
operate as intended. 
14.5. The devices shall be designed and manufactured  in such a way as to avoid, as far as 
possible, the risk of accident al electric shocks to the us er, professional or lay, or 
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  installed and maintained as indicated 
by the manufacturer. 
15. Protection against mechanic al and thermal risks 
15.1. The devices shall be designed and manufactured  in such a way as to protect the user, 
professional or lay, or other pers on against mechanical risks.   
EN 91   EN 15.2. The devices shall be sufficiently stable under the foreseen operating conditions. They 
shall be suitable to withstand stresses inhe rent in the foreseen working environment, 
and to retain this resistance during the expected lifetime of the devices, subject to any 
inspection and maintenan ce requirements as indicated by the manufacturer. 
15.3. Where there are risks due to the presence of moving parts, risks due to break-up or 
detachment, or leakage of substances, th en appropriate protect ion means shall be 
incorporated. 
Any guards or other means included with the device to provi de protection, in 
particular against moving parts, shall be s ecure and shall not interfere with access for 
the normal operation of the device, or restri ct routine maintenance of the device as 
intended by the manufacturer. 
15.4. The devices shall be designed and manufactured in such a way as to reduce to the 
lowest possible level the risks arising from  vibration 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. 
15.5. The devices shall be designed and manufactured in such a way as to reduce to the 
lowest possible level the risks arising from the noise emitted, taking account of 
technical progress and of the means availabl e to reduce noise, particularly at source, 
unless the noise emitted is part of the specified performance.  
15.6. Terminals and connectors to the electric ity, gas or hydraulic and pneumatic energy 
supplies which the user, professional or lay, or other person has to handle shall be 
designed and constructed in such a way as to minimise all possible risks. 
15.7. 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. 
15.8. 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. 
16. Protection against the risks posed by devices intended by the manufacturer for 
self-testing or near-patient testing 
16.1. The devices intended for self-testing or ne ar-patient testing sh all be designed and 
manufactured in such a way that they perform appropriately for their intended 
purpose taking into account the skills and th e means available to the intended user 
and the influence resulting from variation that can be reasonably anticipated in the 
intended user's technique and environmen t. The information and instructions 
provided by the manufacturer shall be easy for the intended user to understand and 
apply.  
16.2. The devices intended for self-testing or ne ar-patient testing sh all 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 92   EN – reduce as far as possible the risk of erro r by the intended user in the handling of 
the device and, if applicable, the specime n, and also in the interpretation of the 
results. 
16.3. The devices intended for self-testing and n ear-patient testing shall, where reasonably 
possible, include a procedure by which the intended user can: 
– verify that, at the time of use, th e device will perform as intended by the 
manufacturer; and 
– be warned if the device has fa iled to provide a valid result. 
III. REQUIREMENTS REGARDING INFORMATION SUPPLIED WITH THE DEVICE  
17. Label and instructions for use 
17.1. General requirements regarding the info rmation supplied by the manufacturer 
Each device shall be accompanied by the inform ation needed to identify the device and its 
manufacturer, and communicate safety and perf ormance related information to the user, 
professional or lay, or other pe rson, as appropriate. Such information may appear on the 
device itself, on the packaging or in  the instructions for use, taki ng into account the following:  
(i) The medium, format, content, legibility, a nd location of the label and instructions for 
use shall be appropriate to the particul ar device, its inte nded purpose and the 
technical knowledge, ex perience, 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, supp lemented with drawings and diagrams. 
Some devices may include separate information for the professional user and the lay person. 
(ii) The information required on the label, shal l be provided on the device itself. If this is 
not practicable or appropria te, some or all of the information may appear on the 
packaging for each unit, and/or on th e packaging of multiple devices. 
Where multiple devices are supplied to a singl e user and/or locati on, a single copy of 
the instructions for use may be provided if  so agreed by the purchaser who in any 
case may request further copies to be provided.  
(iii) In duly justified and exceptional cases in structions for use may not be needed or may 
be abbreviated if the device can be used safely and as intended by the manufacturer 
without any such instructions for use. 
(iv) Labels shall be provided in a human-read able format but may be supplemented by 
machine-readable forms, such as radio-fre quency identification (R FID) or bar codes. 
(v) When the device is intended for professi onal use only , instructions for use may be 
provided to the user in non-paper format (e .g. electronic), except  when the device is 
intended for near-patient testing. 
(vi) Residual risks which are required to be communicated
 to the user and/or other person 
shall be included as limitations, contraindi cations, precautions or warnings in the 
information supplied by the manufacturer. 
(vii) Where appropriate, this information should take the form of internationally 
recognised symbols. Any symbol or identifi cation colour used shall conform to the 
harmonised standards or CTS. In areas for which no standards or CTS exist, the  
EN 93   EN symbols and colours shall be described in the documentation supplied with the 
device. 
(viii) In the case of devices  containing a substance or a mi xture which may be considered 
as being dangerous, taking account of the na ture and quantity of its constituents and 
the form under which they are present, relevant hazard pictograms and labelling 
requirements of Regulation (EC) 1272/2008 sh all apply. Where there is insufficient 
space to put all the information on the device it self or on its label, the relevant hazard 
pictograms shall be put on the label and the other information required by that Regulation shall be given in the instructions for use. 
(ix) The provisions of Regulation (EC) 1907/ 2006 on the safety data sheet shall apply, 
unless all relevant information as appropr iate is already made available by the 
instructions for use. 
17.2. Information on the label 
The label shall bear the following particulars:  
(i) The name or trade name of the device; (ii) The details strictly nece ssary for the user to identify the device and, where it is not 
obvious for the user, the intended purpose of the device; 
(iii) The name, registered trade name or regist ered trade mark of the manufacturer and the 
address of his registered place of busine ss at which he can be contacted and his 
location be established; 
(iv) 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 which he  can be contacted and his location be 
established; 
(v) An indication that the device is for in vitro diagnostic use;  
(vi) The batch code/lot number or the serial number of the device preceded by the word 
LOT or SERIAL NUMBER or an equi valent symbol, as appropriate; 
(vii) Where applicable, the uni que device identification (UDI); 
(viii) An unambiguous indication of the date until when the device may be used safely, 
without degradation of perfor mance, expressed at least as the year, the month and, 
where relevant, the day, in that order; 
(ix) Where there is no indication of the date un til 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 the date is  clearly identifiable;  
(x) Where relevant, an indication of the net quantity of contents, expressed in terms of 
weight or volume, numerical count, or a ny combination of these, or other terms 
which accurately reflect the contents of the package; 
(xi) An indication of any sp ecial storage and/or handli ng condition that applies;  
(xii) Where appropriate, an indication of the st erile state of the device and the sterilisation 
method, or a statement indicating any speci al microbiological st ate or state of 
cleanliness; 
(xiii) Warnings or precautions to be taken that need to be brought to the immediate 
attention of the user, professional or lay, or other person. This information may be  
EN 94   EN kept to a minimum in which case more de tailed information shall appear in the 
instructions for use;  
(xiv) Where applicable, any part icular operating instructions; 
(xv) 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; 
(xvi) If the device is intended for self-testing or near-patient testing, an indication of that 
fact; 
(xvii) If the device is for performance ev aluation only, an indi cation of that fact; 
(xviii) Where device kits incl ude individual reagents and articles that may be made 
available as separate devices , each of these devices shall comply with the labelling 
requirements contained in this Section;  
(xix) Wherever reasonable and practicable, the devices and separate components shall be 
identified, where appropriate in terms of ba tches, to allow all appropriate action to 
detect any potential risk posed by th e devices and detachable components.   
17.3. Information in the instructions for use 
17.3.1.  The instructions for use shall co ntain the following particulars: 
(i) The name or trade name of the device; 
(ii) The device’s intended purpose:  
– what is detected and/or measured;  
– its function (e.g. screening, monitoring, diagnosis or  aid to diagnosis);  
– the specific disorder, condition or risk fact or of interest that it is intended to 
detect, define or differentiate;  
– whether it is automated or not; 
– whether it is qualitative, semi -quantitative or quantitative; 
– the type of specimen(s) required; and  
– where applicable, th e testing population. 
(iii) An indication that the device is for in vitro diagnostic use; 
(iv) The intended user, as appropriate (e.g. h ealthcare professionals, lay person); 
(v) The test principle; (vi) A description of the reagents, calibra tors and controls a nd any limitation upon their 
use (e.g. suitable for a de dicated instrument only); 
(vii) A list of materials provided  and a list of special materi als required but not provided; 
(viii) 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.  
EN 95   EN (ix) An indication of any speci al storage (e.g. temperature, light, humidity, etc.) and/or 
handling conditions which apply; 
(x) In-use stability which may include the storage conditions, and shelf life following the 
first opening of the primary container, together with the st orage conditions and 
stability of working solutions, where this is relevant; 
(xi) If the device is supplied as sterile, an indicatio n of its sterile state, the sterilisation 
method and instructions in th e event of the sterile packaging being damaged before 
use; 
(xii) Information that allows the user to be informed of any warnings, precautions, 
measures to be taken and limitations of us e regarding the device. This information 
shall cover, where appropriate:  
– warnings, precautions and/or measures to be taken in the event of malfunction 
of the device or its degradation as sugge sted by changes in its appearance that 
may affect performance;  
– warnings, precautions and/or measures to be taken in regards to the exposure to 
reasonably foreseeable exte rnal influences or envi ronmental conditions, such 
as magnetic fields, external electrical a nd electromagnetic effects, electrostatic 
discharge, radiation associated with diagnostic or therapeutic procedures, 
pressure, humidity, or temperature;  
– warnings, precautions and/or measures to be taken in regards to the risks of 
interference posed by the reasonably fore seeable presence of the device during 
specific diagnostic investigations, evalua tions, therapeutic treatment or other 
procedures (e.g. electromagnetic interf erence emitted by the device affecting 
other equipment);  
– precautions related to materials incorp orated into the device that are 
carcinogenic, mutagenic or toxic, or that  have endocrine disrupting properties 
or that could result in sensitisation or allergic reaction of the patient or user; 
– 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; 
– if the device is reusable, information on the appropriate processes to allow 
reuse, including cleaning, disinfection, decontamination, packaging and, where 
appropriate, the validated method of re -sterilization. Information shall 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. 
(xiii) Any warnings and/or precautions related to potentially infectious material that is 
included in the device; 
(xiv) Where relevant, requirements for special  facilities (e.g. clean room environment) or 
special training (e.g. radiation safety), or particular qualifications of the device 
intended user; 
(xv) Conditions for collection, handli ng, and preparation of the specimen; 
(xvi) Details of any preparatory treatment or handling of the device before it is ready for 
use (e.g. sterilisation, final assembly, calibration, etc.);  
EN 96   EN (xvii) The information needed to verify whet her the device is prope rly installed and is 
ready to perform safely and as intended by the manufacturer, t ogether with, where 
relevant:  
– details of the nature, and frequency, of  preventative and regular maintenance, 
including cleaning and disinfection; 
– identification of any consumable components and how to replace them; 
– information on any necessary calibration to ensure that the device operates 
properly and safely durin g its intended lifetime; 
– methods of mitigating the risks encountered by persons involved in installing, 
calibrating or servicing devices. 
(xviii) Where relevant, recommendatio ns for quality control procedures; 
(xix) The metrological traceability of values assigned to calibrators and trueness-control 
materials, including identification of applicable reference materials and/or reference measurement procedures of higher order; 
(xx) Assay procedure including calculations and interpretation of results and where 
relevant if any confirmatory testing shall be considered; 
(xxi) Analytical performance characteristics, such as sensitivity, specificity, and accuracy, 
repeatability, reproducibili ty, limits of detection and measurement range, including 
information needed for the control of known relevant interferences, limitations of the 
method and information about the use of available reference measurement 
procedures and materials by the user; 
(xxii) Where relevant, clinical performance ch aracteristics, such as  diagnostic sensitivity 
and diagnostic specificity; 
(xxiii) Where relevant, reference intervals; (xxiv) Information on interfering substan ces or limitations (e.g. visual evidence of 
hyperlipidaemia or haemolysis, age of specime n) that may affect the performance of 
the device; 
(xxv) Warnings or precautions to be taken in order to facilitate the safe disposal of the 
device, its accessories, and the consumables used with it, if a ny. This information 
shall cover, where appropriate:  
– infection or microbial hazards (e.g. cons umables contaminated with potentially 
infectious substances of human origin);  
– environmental hazards (e.g. batteries or materials that emit potentially 
hazardous levels of  radiation);  
– physical hazards (e.g. explosion). 
(xxvi) The name, registered trade name or regist ered trade mark of the manufacturer and the 
address of his registered place of busine ss at which he can be contacted and his 
location be established, together with a telephone number and/or fax number and/or 
website address to obtain technical assistance;  
(xxvii) Date of issue of the inst ructions for use or, if they ha ve been revised, date of issue 
and identifier of the latest revi sion of the instructions for use;  
EN 97   EN (xxviii) A notice to the user, prof essional or lay, that any serious incident that ha s occurred in 
relation to the device shoul d be reported to the manuf acturer and the competent 
authority of the Member State where the user and/or patient is established; 
(xxix) Where device kits include  individual reagents and article s that may be made available 
as separate devices, each of these devices sh all comply with the instructions for use 
requirements contained in this Section.  
17.3.2.  In addition, the instructions for use for devices intended for self-testing or near-
patient testing shall comply with the following principles: 
(i) Details of the test procedure shall be  given, including any reagent preparation, 
specimen collection and/or preparation and information on how to run the test and read the results;  
(ii) The results need to be expressed and pres ented in a way that is readily understood by 
the intended user;  
(iii) Information needs to be provided with a dvice to the user on action to be taken (in 
case of positive, negative or indeterminate result), on the test limitations and on the possibility of false positive or false negative result. Information shall also be provided as to any factors that can affect the test  result (e.g. age, gender, 
menstruation, infection, exercise, fasting, diet or medication); 
(iv) for devices intended for self-testing, the information provided shall include a 
statement clearly directing th at the user should not take  any decision of medical 
relevance without first consulting th e appropriate healthcare professional; 
(v) for devices intended for self-testing used for the monitoring of an existing disease, 
the information shall specify that the patient  should only adapt the treatment if he has 
received the appropriate  training to do so.  
EN 98   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 22(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 purpose of the device which may include:  
(i) what is detected and/or measured; (ii) its function (e.g. screening, monitori ng, diagnosis or aid to diagnosis);  
(iii) the specific disorder, condition or risk  factor of interest that it is intended 
to detect, define or differentiate;  
(iv) whether it is automated or not;  (v) whether it is qualitative, semi -quantitative or quantitative;  
(vi) the type of specimen(s) required;  (vii) where applicable, the testing population;  
(viii) the intended user. 
(d) the description of the principle of the a ssay method or instrument principles of 
operation;  
(e) the risk class of the device and the app licable classificatio n rule according to 
Annex VII;  
(f) the description of the components and wh ere appropriate, the description of the 
reactive ingredients of relevant com ponents (such as antibodies, antigens, 
nucleic acid primers); 
and where applicable:  
(g) the description of the specimen collec tion and transport materials provided 
with the device or descriptions of specifications recommended for use;  
(h) for instruments of automated assays: th e description of the appropriate assay 
characteristics or dedicated assays;  
(i) for automated assays: a description of the appropriate instrumentation 
characteristics or dedicated instrumentation;   
EN 99   EN (j) a description of any software to  be used with the device;  
(k) a description or complete list of the various configuratio ns/variants of the 
device that will be made available;  
(l) a description of th e accessories, other in vitro  diagnostic medical devices and 
other products, which are intended to be used in combination with the device.  
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  
3.1. Design information 
Information to allow a general understanding of the design stages applied to the device.  
This shall include: 
(a) the description of the cri tical ingredients of the device such as antibodies, 
antigens, enzymes and nucleic acid prim ers provided or recommended for use 
with the device;  
(b) for instruments, the description of ma jor subsystems, analytical technology 
(e.g. operating principles, control mechan isms), dedicated computer hardware 
and software;  
(c) for instruments and software, the ov erview of the entire system;  
(d) for standalone software, the descripti on of the data interpretation methodology 
(i.e. algorithm);  
(e) for devices intended for self-testing or  near-patient testing devices the 
description of the design aspects that make them su itable for self-testing or 
near-patient testing.  
3.2. Manufacturing information 
(a) Information to allow a general underst anding of the manufacturing processes 
such as production, assembly, final product testing, and packaging of the 
finished device. More detailed informa tion needs to be provided for the audit 
of the quality management system or ot her applicable conformity assessment 
procedures;   
EN 100   EN (b) identification of all sites, including suppliers and sub-contractors, where 
manufacturing activit ies are performed.  
4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS  
The documentation shall contain information re garding the solu tions adopted to meet the 
general safety and performan ce requirements laid down in A nnex 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. 
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  Section 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 and valid ation testing and/or 
studies undertaken to demonstrat e conformity of the device w ith the requirements of this 
Regulation and in particular th e applicable general safety and performance requirements.  
This includes:  
6.1 Information on analytical performance 
6.1.1 Specimen type  
This section shall describe the different spec imen types that can be  used, including their 
stability (e.g. storage and where applicable transport conditions) and storage conditions (e.g. 
duration, temperature limits and freeze/thaw cycles).  
6.1.2 Analytical performance characteristics  6.1.2.1 Accuracy of measurement  
(a) Trueness of measurement 
This section shall provide information on the trueness of the measurement procedure 
and summarise the data in sufficient detail  to allow assessment of the adequacy of 
the means selected to establish the tr ueness. Trueness measures apply to both  
EN 101   EN quantitative and qualitative assays only wh en a reference standard or method is 
available. 
(b) Precision of measurement 
This section shall describe repeatability and reproducibility studies. 
6.1.2.2 Analytical sensitivity This section shall include information about the study design and results . It shall provide a 
description of specimen type a nd preparation including matrix, an alyte levels, and how levels 
were established. The number of replicates tested at each con centration shall also be provided 
as well as a description of the calculation used to determine assay sensitivity. 
6.1.2.3 Analytical specificity  This section shall describe inte rference and cross reactivity studies  to determine the analytical 
specificity in the presence of other substances/agents in the specimen. 
Information shall be provided on the evaluation of potentially interfer ing and cross reacting 
substances/agents on the assay, on the substa nce/agent type and concentration tested, 
specimen type, analyte test concentration, and results. 
Interferents and cross reacting substances/age nts, which vary greatly depending on the assay 
type and design, could derive from e xogenous or endogenous sources such as: 
(a) substances used for patient treatment (e.g. medicinal products); 
(b) substances ingested by the patient (e.g. alcohol, foods); 
(c) substances added during specimen prepara tion (e.g. preservatives, stabilisers); 
(d) substances encountered in specific sp ecimens types (e.g. haemoglobin, lipids, 
bilirubin, proteins); 
(e) analytes of similar structure (e.g. precursors, metabolites) or medical 
conditions unrelated to the test conditio n including specimens negative for the 
assay but positive for a condition th at may mimic the test condition. 
6.1.2.4 Metrological traceability  of calibrator and cont rol material values 
6.1.2.5 Measuring range of the assay This section shall include information on the measuring range (linear and non-linear 
measuring systems) including the limit of detec tion and describe information on how these 
were established.  
This information shall include a description of  specimen type, number of specimen, number 
of replicates, and preparation including informa tion on matrix, analyte levels and how levels 
were established. If applicable, a description of high dose hook effect and the data supporting 
the mitigation (e.g. dilution)  steps shall be added. 
6.1.2.6 Definition of assay cut-off 
This section shall provide a summary of analytical  data with a description of the study design 
including methods for determining the assay cut-off, including:  
(a) the population(s) studied (demographics / selection / inclus ion and exclusion 
criteria / number of individuals included);  
(b) method or mode of characterisation of specimens; and   
EN 102   EN (c) statistical methods e.g. Receiver Operat or Characteristic (ROC) to generate 
results and if applicable, defi ne grey-zone/equivocal zone.  
6.2 Information on clinical performance 
Where applicable, the documentation shall cont ain data on the clinical  performance of the 
device. 
The clinical evidence report referred to in Sec tion 3 of Annex XII sha ll be included and/or 
fully referenced in the technical documentation. 
6.3 Stability (excluding specimen stability)  
This section shall describe claimed shelf life, in use stability and shi pping stability studies.  
6.3.1 Claimed shelf life 
This section shall provide information on stabilit y testing studies to support the claimed shelf 
life. Testing shall be performed on at least th ree different lots manufactured under conditions 
that are essentially equivalent to routine produc tion conditions (these lots do not need to be 
consecutive lots). Accelerated studies or extrap olated data from real time data are acceptable 
for initial shelf life claim but need to be followed up with real time stability studies.  
Such detailed information shall describe:  
(a) the study report (including the protocol, num ber of lots, acceptance criteria and 
testing intervals);  
(b) when accelerated studies have been perf ormed in anticipation of the real time 
studies, the method used fo r accelerated studies;  
(c) the conclusions and claimed shelf life.  
6.3.2 In-use stability  
This section shall provide information on in-use stability studies for one lot reflecting actual 
routine use of the device (real or simulated). Th is may include open vial stability and/or, for 
automated instruments, on board stability.  
In the case of automated instrumentation if calibration stability is claimed, supporting data 
shall be included.  
Such detailed information shall describe:  
(a) the study report (including the protocol, acceptance criteria and testing 
intervals);  
(b) the conclusions and claimed in-use stability.  
6.3.3 Shipping stability 
This section shall provide information on shipping stability studies for one lot to evaluate the 
tolerance of products to the an ticipated shipping conditions.  
Shipping studies can be done under real and/or s imulated conditions and shall include variable 
shipping conditions such as ex treme heat and/or cold.  
Such information shall describe:  
(a) the study report (including the pr otocol, acceptance criteria);  
(b) the method used for simulated conditions;  
(c) the conclusion and recommende d shipping conditions.   
EN 103   EN 6.4 Software verification and validation  
The documentation shall contain evidence of the validation of the software, as used in the 
finished device. This information shall typically include the summary results of all verification, validation and testing performed in -house and as applicable in an actual user 
environment prior to final rel ease. It shall also address al l of the different hardware 
configurations and, where applicable, operati ng systems identified in the labelling.  
6.5 Additional information in specific cases 
(a) 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.  
(b) In the case of devices containing tissues, cells and substances of animal, human 
or microbial origin, information on the origin of such material and on the 
conditions in which it was collected. 
(c) 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. 
(d) If the device is to be connected to other equipment 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 
equipment having regard to the characte ristics specified by the manufacturer.   
EN 104   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 declaration of conform ity 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 22(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 the rules set out in 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 105   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 106   EN ANNEX V  
INFORMATION  TO BE SUBMITTED  WITH  THE  REGISTRATION  OF 
DEVICES  AND  ECONOMIC  OPERATORS  IN ACCORDANCE  WITH  
ARTICLE  23  
AND 
DATA  ELEMENTS  OF THE  UDI  DEVICE  IDENTIFIER  IN 
ACCORDANCE  WITH  ARTICLE  22 
Part A 
Information to be submitted with the registrat ion of devices in accordance with Article 
23 
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 18 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 B, C or D: Member States where the device is 
or shall be made available, 
8. in case of imported devi ce: country of origin, 
9. presence of tissues, cells or subs tances of human origin (y/n), 
10. presence of tissues, cells or substa nces of animal origin (y/n),  
11. presence of cells or substances of microbial origin (y/n), 
12. risk class of the device according to  the rules set out in Annex VII, 
13. where applicable, single identification number of the interventional clinical 
performance study and other clinical pe rformance study involving risks for the 
subjects of the study conducte d in relation to the device  (or link to the clinical 
performance study registration in the el ectronic system regarding clinical 
performance studies), 
14. 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,  
EN 107   EN 15. in case of devices classified as class C or D, the summary of safety and performance, 
16. status of the device (on the market, no longer manufactured, withdrawn from the 
market, recalled), 
17. indication when the device is a 'new' device. 
A device shall be considered as 'new' if:  (a) there has been no such device continuous ly available on the Union market 
during the previous three years for the relevant analyte or other parameter; 
(b) the procedure involves an alytical technology not continuously used in 
connection with a given analyte or othe r parameter on the Union market during 
the previous three years. 
18. Indication if the device is intended for self-testing or near-patient testing. 
Part B 
Data elements of the UDI device iden tifier in accordance with Article 22 
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 contro lled (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 'un it of use' device identif ier 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, 
9. if applicable, device model, re ference, or catalogue number, 
10. additional product desc ription (optional), 
11. if applicable, storag e and/or handling condi tions (as indicated on the label or in the 
instructions for use), 
12. if applicable, additional tr ade names of the device,  
13. labelled as single use device (y/n), 
14. if applicable, restricted number of reuses, 
15. device packaged sterile (y/n), 
16.
 need for sterilisation before use (y/n), 
17. URL for additional information, e.g. electr onic instructions for use (optional),  
EN 108   EN 18. if applicable, critical warn ings or contraindications.  
EN 109   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 established under th e 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 documentation of its legal personality and status. This 
shall include information about ownership a nd the legal or natural persons exercising 
control over the notified body.  
1.1.2.  If the notified body is a legal entity that is part of a larger 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 thos e entities, as well 
as their legal and operationa l relationships with the no tified 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 performs 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 an d operated so as to safeguard the 
independence, objectivity and impartiality of its activities. The notified body shall 
have procedures in place th at effectively ensure iden tification, investigation and 
resolution of any case in which a conflict of interests may arise, including involvement in consultancy services in the field of in vitro  diagnostic medical 
devices prior to taking up empl oyment 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 
parties. This shall not pr eclude the purchase 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 the design, manu facture or construction, the marketing, 
installation, use or maintena nce of the products which th ey assess, or represent  
EN 110   EN the parties engaged in those 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 may jeopardise the confidence in their 
independence, impartiality or objectivity. In  particular, they shall not offer or 
provide consultancy services to the manu facturer, his authoris ed 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 entity or institution, independence and 
absence of any conflict of interests sha ll 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 associated 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 their tasks under this Regulation, except in relation to the 
national authorities responsible for notified bodies, competent authorities or the Commission. Proprietary rights shall be pr otected. To this end, the notif ied body shall have documented 
procedures in place. 
1.4. Liability 
The notified body shall take out appropriate lia bility insurance that  corresponds to the 
conformity assessment activities for which it is notified, including the possible suspension, 
restriction or withdrawal of certificates, and the geographic sc ope of its activities, unless 
liability is assumed by the State in accordance w ith national law, or the Member State itself is 
directly responsible for th e conformity assessment.  
1.5. Financial requirements 
The notified body shall have at its disposal the financial resources required to conduct its 
conformity assessment activities and relate d business operations. It shall document and 
provide evidence of its financia l capacity and its sustainable economic viability, taking into 
account specific circumstances du ring an initial start-up phase.  
EN 111   EN 1.6. Participation in coordination activities 
1.6.1.  The notified body shall participate in, or ensure that its assessment 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 legislation, guid ance 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 no tified bodies in the field of in vitro  diagnostic 
medical devices that is accepted by the na tional authorities res ponsible for notified 
bodies. The code of conduct shall provide for a mechanism of monitoring and verification of its implem entation 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 appropria te to the nature, area and scale of its 
conformity assessment activ ities and capable of supporting 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;  
– 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 task s 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 personnel 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 performan ce of devices for which it has been notified, having  
EN 112   EN regard to the requirements of this Regula tion and, in particular, 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 which it has been  notified, a notified body shall have within 
its organisation the necessary administrative , technical and scient ific personnel with 
technical knowledge and sufficient a nd appropriate experience relating to in vitro  
diagnostic medical devices and the corre sponding 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 au thorities in relation of the personnel invol ved 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 authorisation of pers ons involved in conformity assessment 
activities (knowledge, experience and other competence 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 c overed by the scope of designation. 
3.2.2.  The qualification criteria shall refer to th e scope of the notified body's designation in 
accordance with the scope description used by the Member State for the notification 
referred to in Article 31, pr oviding sufficient level of detail for the required 
qualification within the subdivisi ons of the scope description.  
Specific qualification criteria shall be defi ned for the assessment of biocompatibility 
aspects,  clinical evaluation and th e different types of st erilisation processes. 
3.2.3.  The personnel responsible for authorising other pers onnel to perform specific 
conformity assessment activitie s and the personnel with overall responsibility for the 
final review and decision-making on certif ication shall be em ployed by the notified 
body itself and shall not be subcontracted. This personnel altogether shall have 
proven knowledge and experience in the following: 
– Union in vitro diagnostic medical devices legi slation and relevant guidance 
documents; 
– the conformity assessment procedures in accordance with this Regulation; 
– a broad base of in vitro diagnostic medical device technologies, the in vitro 
diagnostic medical device industry and the design and manufacture of in vitro 
diagnostic 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 conform ity assessments in relation to in vitro 
diagnostic medical devices as well as the relevant qualification criteria; 
– training relevant to personnel involved in  conformity assessment activities in 
relation to in vitro diagnostic medical devices; 
– the ability to draw up cert ificates, records and reports  demonstrating that the 
conformity assessments have b een appropriately carried out.  
EN 113   EN 3.2.4.  Notified bodies shall have available personnel with clinical expert ise. 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 require d for the assessment 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 cont ained within the manufacturer's clinical 
evaluation with the manufacturer 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 clinical data presented, and the results of 
the external clinical experts' asse ssment of the manufacturer's clinical 
evaluation; 
– be able to ascertain the comparabil ity and consistency of the clinical 
assessments conducted by clinical experts; 
– 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 documentation review or type examination including aspects such 
as clinical evaluation, steril isation, software validation)  shall have the following 
proven qualification: 
– successful completion of a university or a technical co llege 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 experien ce) 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 rela ted 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 in vitro 
diagnostic medical device sta ndards and guidance documents; 
– appropriate knowledge and experien ce 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.  
EN 114   EN 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 co llege degree or 
equivalent qualification in relevant studi es, e.g. medicine, natural sciences or 
engineering; 
– four years professional expe rience in the field of hea lthcare products or related 
sectors (e.g. industry, audit, healthcare , research experien ce) whilst two years 
of this experience shall be in the area of quality management; 
– appropriate knowledge of the in vitro diagnostic medical devi ces legislation as 
well as related delegated and/or implem enting acts, harmonised standards, CTS 
and guidance documents; 
– appropriate knowledge and experience of risk management and related in vitro 
diagnostic medical device sta ndards and guidance documents; 
– appropriate knowledge of quality manage ment systems and related standards 
and guidance documents;  
– appropriate knowledge and experien ce 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 techni ques enabling them 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. Wh ere in exceptional 
circumstances the fulfilment of the qualific ation criteria set out  in Section 3.2 cannot 
be fully demonstrated, the notified body shal l appropriately justif y the authorisation 
of this personnel to carry out specific conformity assessment activities.  
3.3.2.  For its personnel referred to in Sections 3.2.3 to  3.2.6, the notified body shall 
establish and maintain up to date: 
– a matrix detailing the responsibilities of the personnel in  respect of the 
conformity assessment activities;  
– records demonstrating the require d knowledge and experience for the 
conformity assessment activity for which they are authorised.  
EN 115   EN 3.4. Subcontractors and external experts  
3.4.1.  Without prejudice to the limitations eman ating from Section 3.2., the 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 activities either to an 
organisation or an individual, it shall ha ve a policy describing 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 external experts ar e used in the context of the conformity 
assessment, the notified body shall have ad equate own competence in each product 
area for which it is designated to lead the conformity assessment, to verify the appropriateness and validity of expert  opinions and make the decision on the 
certification. 
3.4.4.  The notified body shall establish procedures 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.  
3.5.2.  It shall review the competence of its personne l and identify training needs in order to 
maintain the required level of qualification and knowledge.  
4. P
ROCESS REQUIREMENTS  
4.1. The notified body's decision-making process shall be clearly documented, 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 whic h it is designated taking into account their 
respective specificities, including legally required consultations, in respect of the different categories of devices covered by the scope of notif ication, 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 as sessment by a manufacturer or by an 
authorised representative, 
– the processing of the applic ation, including the verifica tion of the completeness 
of the documentation, the quali fication of the product as in vitro diagnostic 
medical 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,  
EN 116   EN – the assessment of relevant changes to be submitted for prior approval,  
– the planning of surveillance,  
– the renewal of certificates.   
EN 117   EN ANNEX VII  
CLASSIFICATION  CRITERIA 
1. IMPLEMENTING RULES FOR THE CLASSIFICATION RULES  
1.1. Application of the classifi cation rules shall be governed  by the intended purpose of 
the devices. 
1.2. If the device is intended to be used in combination with another device, the 
classification rules shall apply sepa rately to each of the devices.  
1.3. Accessories are classified in their own ri ght separately from the device with which 
they are used. 
1.4. Standalone software, which drives a device or influences the use of a device, falls 
automatically in the same class as the devi ce. If standalone software is independent 
of any other device, it is clas sified in its own right.  
1.5. Calibrators intended to be used with a device  shall be classified in the same class as 
the device.  
1.6. Standalone control materials with quantitati ve or qualitative a ssigned values intended 
for one specific analyte or multiple analytes shall be classified in the same class as 
the device.  
1.7. The manufacturer shall take into consideratio n all the rules in order to establish the 
proper classification for the device.  
1.8. Where a device has multiple intended purposes stated by the manufacturer, which 
place the device into more than one class, it sh all be classified in the higher class.  
1.9. If several classification rules apply to the same device the rule resulting in the higher 
classification shall apply. 
2. CLASSIFICATION RULES  
2.1. Rule 1 
Devices intended for the followi ng purposes are classified as class D :  
– Devices intended to be used to detect  the presence of, or exposure to, a 
transmissible agent in blood, blood component s, cells, tissues or organs, or in 
any of their derivatives, in order to a ssess their suitability for transfusion or 
transplantation. 
– Devices intended to be used to detect  the presence of, or exposure to, a 
transmissible agent that causes a life- threatening disease with a high or 
currently undefined risk of propagation. 
This rule applies to first line assays, confirmatory assays and supplemental assays. 
2.2. Rule 2 
Devices intended to be used for blood grouping, or  tissue typing to ensure the immunological 
compatibility of blood, blood components, cells , tissue or organs that are intended for 
transfusion or transplant ation, are classified as class C, except when intended to determine 
any of the following markers: 
– ABO system [A (ABO1), B (ABO2), AB (ABO3)];  
EN 118   EN – Rhesus system [RH1 (D), RH2 (C ), RH3 (E), RH4 (c), RH5 (e)]; 
– Kell system [Kel1 (K)]; 
– Kidd system [JK1 (Jka), JK2 (Jkb)]; 
– Duffy system [FY1 (Fya), FY2 (Fyb)]  
in which case they are classified as class D.  
2.3. Rule 3 
Devices are classified as class C  if they are intended for:  
(a) detecting the presence of, or exposure to, a sexually transmitted agent; 
(b) detecting the presence in cerebrospinal fluid or blood of an infectious agent 
with a risk of limited propagation;  
(c) detecting the presence of an infectious ag ent, if there is a significant risk that 
an erroneous result would cause death or severe disability to the individual or foetus being tested, or to th e individual's offspring;  
(d) pre-natal screening of women in orde r to determine their immune status 
towards transmissible agents; 
(e) determining infective disease status or imm une status, if there is a risk that an 
erroneous result would lead to a patien t management decision resulting in an 
imminent life-threatening situation for the patient or for the patient's offspring; 
(f) selection of patients,  i.e. 
(i) Devices intended to be used as companion diagnostics; or (ii) Devices intended to be us ed for disease staging; or 
(iii) Devices intended to be used in screening for or in  the diagnosis of 
cancer. 
(g) human genetic testing; 
(h) monitoring of levels of medicinal products, s ubstances or biological 
components, when there is a risk that an erroneous result will lead to a patient 
management decision resulting in an immi nent life-threatening situation for the 
patient or for the patient's offspring; 
(i) management of patients suffering from a life-threatening infectious disease;  
(j) screening for congenital disorders in the foetus.  
2.4. Rule 4 
(a) Devices intended for self-testing are classi fied as class C, except those devices 
from which the result is not determini ng a medically critica l status, or is 
preliminary and requires follow-up with  the appropriate la boratory test in 
which case they are Class B.  
(b) Devices intended for blood gases and bl ood glucose determinations for near-
patient testing are class C. Other devi ces that are intended for near-patient 
testing shall be classifi ed in their own right. 
2.5. Rule 5 
The following devices are classified as class A :  
EN 119   EN (a) reagents or other articles which possess specific characteristics, intended by the 
manufacturer to make them suitable for in vitro  diagnostic procedures related 
to a specific examination; 
(b) instruments intended by the manufactur er specifically to be used for in vitro  
diagnostic procedures;  
(c) specimen receptacles. 
2.6. Rule 6 
Devices not covered by the above-mentioned classification rules are classified as class B . 
2.7. Rule 7 
Devices which are controls wit hout a quantitative or qualitative assigned value are classified 
as class B .  
EN 120   EN ANNEX VIII  
CONFORMITY  ASSESSMENT  BASED  ON  FULL  QUALITY  
ASSURANCE  AND  DESIGN  EXAMINATION   
Chapter I: Full Qualit y Assurance System 
1. The manufacturer shall ensure applicati on of the quality management system 
approved for the design, manufacture and fi nal inspection of the devices concerned, 
as specified in Secti on 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 15 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 th is Regulation which apply to them. 
3. Quality management system 
3.1. The manufacturer shall lodge an app lication 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 the application is 
lodged by the authorised re presentative, 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 application 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 procedures in place to keep the approved quality 
management system adequate and e fficacious and an 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 follow-up, and the procedures put in 
place to ensure compliance with the oblig ations emanating from the provisions 
on vigilance set out in  Articles 59 to 64, 
– a description of the proce dures in place to keep up to date the post-market 
surveillance plan, including, when app licable, a plan for the post-market 
follow-up, and the procedures ensuri ng compliance with the obligations 
emanating from the provisions on vigilanc e set out in Articles 59 to 64, as well 
as the undertaking by the manufactur er to apply these procedures.  
EN 121   EN 3.2. Application of the quality management system  shall ensure that the devices conform 
to the provisions of this Regul ation which apply to them at every stage, from design 
to final inspection. All the elements, requirements and provi sions 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 submitted 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 structures , the responsibilities of the managerial staff and 
their organisational authority where qual ity of design and manufacture of the 
products is concerned, 
– the methods of monitoring the efficient operation of the quality management 
system and in particular its ability to achieve the desired quality of design and 
of product, including control of pr oducts which fail to conform, 
– where the design, manufacture and/or fi nal inspection and testing of the 
products, or elements thereof, is carri ed out by another party, the methods of 
monitoring the efficient operation of th e quality management system and in 
particular the type and 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 fo r the designation of  an authorised 
representative and a letter of intention of the author ised representative to accept 
the mandate;  
(c) the procedures and techniques for m onitoring, 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 t echniques at the manufacturing stage and 
in particular: 
– the processes and procedures which will be used, particularly as regards 
sterilisation, purchasing a nd the relevant documents, 
– 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 whic h they will take place, and the test 
equipment used; it shall be possible to trace back the calibration of the test 
equipment adequately. 
In addition, the manufacture r shall grant the notified body access to the technical 
documentation referred to in Annex II. 
3.3. Audit  
(a) The notified body shall audit the quality sy stem to determine whether it meets 
the requirements referred to  in Section 3.2. Unless du ly substantiated, it shall  
EN 122   EN presume that quality management sy stems which satisfy the relevant 
harmonised standards or CTS 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 classified  as class C, the audit procedure shall 
include an assessment, on a representati ve basis, of the design documentation 
within the technical documentation as refe rred to in Annex II of the device(s) 
concerned. In choosing representative  sample(s) the notif ied body shall take 
into account the novelty of  the technology, similariti es in design, technology, 
manufacturing and sterilisation methods , the intended purpose and the results 
of any previous relevant assessments th at have been carried out in accordance 
with this Regulation. The notified body shall document 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 issue 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 substa ntial changes to the quality management 
system or the product-range covered. The notified body shall assess the changes proposed and verify whether after these changes 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 conclusions 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. 
4. Surveillance assessment applicable to devices classified as class C and D 
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 authorise the notif ied body to carry 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 follow-up, as well as, if appli cable, any findings resulting from the 
application of the post-market survei llance plan, including the post-market 
follow-up, and of the provisions on vigila nce set out in Articles 59 to 64, 
– the data stipulated in the part of th e quality management system relating to 
design, such as the results of analyses , calculations, tests and the solutions 
adopted regarding the risk-management as referred to in Section 2 of Annex I,  
EN 123   EN – the data stipulated in the part of th e quality management 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 periodi cally, at least every 12 mont hs, carry out appropriate 
audits and assessments to make sure th at the manufacturer applies the approved 
quality management system and the post-ma rket surveillance pla n, and shall supply 
the manufacturer with an assessment report.  This shall include inspections on the 
premises of the manufacturer and, if appr opriate, of the manuf acturer’s suppliers 
and/or subcontractors. At th e time of such inspections, the notified body shall, where 
necessary, carry out or ask for tests in or der to check that th e quality management 
system is working properly. It shall pr ovide the manufacturer with an inspection 
report and, if a test has been car ried out, with a test report. 
4.4. The notified body shall randomly perform una nnounced factory inspections to the 
manufacturer and, if appr opriate, of the manufactur er'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 surv eillance assessment. 
The notified body shall establish a plan fo r the unannounced inspections which shall 
not be disclosed to the manufacturer.  
Within the context of such unannounced inspections, the notified body shall check an 
adequate sample from the pr oduction or the manufacturing process to verify that the 
manufactured device is in conformity with th e technical documentation and/or design dossier. 
Prior to the unannounced inspec tion, the notified body shall sp ecify the relevant sampling 
criteria and testing procedure.  
Instead of, or in addition to, the sampling from the production, the notified body shall take 
samples of devices from the market to verify that the manufactured device is in conformity 
with the technical documentation and/or design  dossier. Prior to the sampling, the notified 
body shall specify the relevant sampli ng criteria and testing procedure. 
The notified body shall provide the manufacture r with an inspection report which shall 
include, if applicable, the re sult of the sample check. 
4.5. In the case of devices classified as class C, 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.  
4.6. The notified body shall ensure that the composition of the assessment team assures 
experience with the technology concerned, c ontinuous objectivity and 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 restrictions on it. 
Chapter II: Design dossier examination 
5. Examination of the design of the device  and batch verification applicable to 
devices in class D   
EN 124   EN 5.1. In addition to the obligati on imposed by Section 3, the manufacturer of devices 
classified as class D shall lodge with the notified body referred to  in Section 3.1 an 
application for the examination of the design dossier relating to the device which he plans to manufacture and which falls into the device category cove red by the quality 
management system referred to in Section 3.  
5.2. The application shall describe the desi gn, manufacture and perf ormances of the 
device in question. It shall include the t echnical 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 tec hnical documentation upon request.  
In the case of devices for self-testing or nea r-patient testing, the a pplication shall also 
include the aspects referred to in Section 6.1, point b). 
5.3. The notified body shall examine the appl ication 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 this Regulation. The 
notified body shall carry out adequate physical  or laboratory tests in relation to the 
device or request the manufacturer  to carry out such tests.  
5.4. Before issuing an EU design-examination certificate, the notif ied body shall request 
a reference laboratory, where designated in  accordance with Article 78, to verify 
compliance of the device with the CTS, when available, or with other solutions chosen by the manufacturer to ensure a leve l of safety and performance that is at 
least equivalent. 
The reference laboratory shall provide a scientific opinion within 30 days.  
The scientific opinion of the reference la boratory and any possible updates shall be 
included in the documentation of the notified body concerning the device. The 
notified body shall give due co nsideration to the views ex pressed in the scientific 
opinion when making its decision. The notif ied body shall not deliver the certificate 
if the scientific opinion is unfavourable.  
5.5. The notified body shall provide the manufact urer with an EU design-examination 
report. 
If the device conforms to the relevant provisions of th is Regulation, the notified body 
shall issue an EU design-examination certif icate. The certificate shall contain the 
conclusions of the examination, the conditions of validity, the data needed for identification of the approved design, wh ere appropriate, a description of the 
intended purpose of the device.  
5.6. Changes to the approved design shall rece ive 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 this 
Regulation or with the condi tions prescribed 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 desi gn-examination report.  
Where the changes could affect compliance with the CTS or with other solutions 
chosen by the manufacturer which we re approved through the EU design- 
EN 125   EN examination certificate, the notified body shall consult the reference laboratory that 
was involved in the initial consultation, in order to confirm that compliance with the 
CTS or with other solutions chosen by the ma nufacturer to ensure a level of safety 
and performance that is at le ast equivalent are maintained. 
The reference laboratory shall provide a scientific opinion within 30 days.  
The approval of any change to the a pproved design shall take the form of a 
supplement to the EU design- examination certificate.  
5.7. To verify conformity of manufactured devices  classified as class D, the manufacturer 
shall carry out tests on the manufactured de vices or each batch of devices. After the 
conclusion of the controls and tests he shall forward to the notified body without 
delay the relevant reports on these tests. Furthermore, the manufacturer shall make 
the samples of manufactured devices or batc hes of devices available to the notified 
body in accordance with pre-agreed condi tions and modalities which shall include 
that the notified body or the manufacturer, in regular intervals, shall send samples of 
the manufactured devices or batches of devices to a reference laboratory, where 
designated in accordance with  Article 78, to carry out appropriate tests. The 
reference laboratory shall inform the notified body about its findings. 
5.8. The manufacturer may place the devices on the market, unless the notified body 
communicates to the manufacturer within the agreed time-frame, but not later than 30 days after reception of the samples, a ny other decision, includi ng in particular any 
condition of validity of delivered certificates. 
6. Examination of the design of specific types of devices  
6.1. Examination of the design of devices fo r self-testing and near-patient testing 
classified as class A, B or C 
(a) The manufacturer of devices for self-testi ng or near-patient te sting classified as 
class A, B and C shall lodge  with the notified body refe rred to in Section 3.1 an 
application for the examination of the design.  
(b) The application shall enable the design of the device to be understood and shall 
enable conformity with the design-relate d requirements of this Regulation to be 
assessed. It shall include: 
– test reports, including resu lts of studies carried ou t with intended users; 
– where practicable, an example of the de vice; if required, th e device shall be 
returned on completion of the design examination; 
– data showing the handling suitability of  the device in view of its intended 
purpose for self-testing or near patient-testing; 
– the information to be provi ded with the device on its la bel and its instructions 
for use. 
The notified body may require the applicati on to be completed by further tests or 
proof to allow assessment of conformity w ith the requirements of this Regulation.  
(c) 
The notified body shall examine the application employing staff with proven 
knowledge and experience regarding the technology concerned and provide the 
manufacturer with an EU design-examination report.  
(d) If the device conforms to the relevant  provisions of this Regulation, the 
notified body shall issue an EU design-examination certificate. The certificate  
EN 126   EN shall contain the conclusions of the ex amination, the conditions of validity, the 
data needed for the identification of the approved design and, where 
appropriate, a description of the intended purpose of the device.  
(e) Changes to the approved design shall rece ive further approval from the notified 
body which issued the EU design-exam ination certificate, wherever the 
changes could affect conformity with  the general safety and performance 
requirements of this Regulation or with the conditions prescribed 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 planne d changes, notify the manufacturer 
of its decision and provide him with a supplement to the EU design-examination report. The approval of a ny change to the a pproved design shall 
take the form of a supplement to th e EU design-examination certificate.  
6.2. Examination of the design of companion diagnostics  
(a) The manufacturer of a companion dia gnostic shall lodge w ith the notified body 
referred to in Section 3.1 an applicati on for the examination of the design.  
(b) The application shall enable the design of the device to be understood and shall 
enable conformity with the design-relate d requirements of this Regulation to be 
assessed, in particular, with regard to the suitability of the device in relation to 
the medicinal product concerned.  
(c) For companion diagnostic intended to be us ed to assess the patie nt eligibility to 
a treatment with a specif ic medicinal product, the notified body shall consult 
before issuing an EU design-examinati on certificate and on the basis of the 
draft summary of safety and performance and the draft instruc tions for use, one 
of the competent authorities designated  by the Member States in accordance 
with Directive 2001/83/EC (hereinafter re ferred to as 'medicinal products 
competent authority') or the European Medicines Agency (hereinafter referred 
to as ‘EMA’) established by the Re gulation (EC) No 726/2004 laying down 
Community procedures for the authoris ation and supervision of medicinal 
products for human and veterinary use an d establishing a Eu ropean Medicines 
Agency
43, regarding the suitability of the de vice in relation to the medicinal 
product concerned. Where the medicinal pr oduct falls exclus ively within the 
scope of the Annex of Regulation (E C) No 726/2004, the notified body shall 
consult the EMA.  
(d) The medicinal products competent authorit y or the EMA shall give its opinion, 
if any, within 60 days after receipt of  valid documentation. This 60-day period 
may be extended only once for a further 60 days on scientifically valid 
grounds. The opinion of the medicinal products authority or of the EMA and any possible update shall be included in  the documentation of the notified body 
concerning the device.  
(e) The notified body shall give due considera tion to the opinion, if any, expressed 
by the medicinal products competent au thority concerned or the EMA when 
making its decision. It shall convey its fi nal decision to the medicinal products 
competent authority concerned or to  the EMA. The design-examination 
certificate shall be delivered in accord ance with point (d) of Section 6.1. 
                                                
 
43 OJ L 136, 30.4.2004, p. 1  
EN 127   EN (f) Before changes affecting the suitabil ity of the device in relation to the 
medicinal product concerned are made, the manufacturer shall inform the 
notified body of the changes, which shall consult the medicinal products 
competent authority that was involved in  the initial consultation or the EMA. 
The medicinal products competent authorit y or the EMA shall give its opinion, 
if any, within 30 days af ter receipt of the valid documentation regarding the 
changes. A supplement to the EU design-ex amination certificat e shall be issued 
in accordance with point (e) of Section 6.1. 
Chapter III: Administrative provisions 
7. The manufacturer or his authorised represen tative shall, for a period ending at least 
five years after the last device has been pla ced 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 Secti ons 5.2 and point (b) of Section 6.1, and 
– the decisions and reports from the notifie d body as referred to  in Sections 3.3, 
4.3, 4.4, 5.5, 5.6, 5.8, points (c), (d) and (e) of Section 6.1, point (e) of Section 
6.2 and point (f) of Section 6.2. 
8. 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 128   EN ANNEX IX  
CONFORMITY  ASSESSMENT  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 app lication is lodged by 
the authorised representative, the na me 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’, w ith 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 no tified body. The notified body 
may request other samples as necessary, 
– in the case of devices for self-testing or near-patient testing, test reports, 
including results of studies carried out with intended users,  and data showing 
the handling suitability of the device in  view of its intended purpose for self-
testing or near patient-testing,  
– a written declaration that no application has been lodged with any other 
notified body for the same type, or info rmation 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 documentation and verify that the type has been 
manufactured in conformity with that docum entation; 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 the appropriate assessments and 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 equipment 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 equipment having the characteri stics specified by the manufacturer; 
3.3. carry out or arrange for the appropriate assessments and 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 129   EN 3.4. agree with the applicant on the place wher e the necessary assessments and tests will 
be carried out; 
3.5. in the case of devices classified as cla ss D, request a reference laboratory, where 
designated in accordance with Article 78, to verify compliance of the device with the 
CTS or with other solutions chosen by the ma nufacturer to ensure a level of safety 
and performance that is at least equivale nt. The reference laboratory shall provide a 
scientific opinion within 30 days. The scie ntific opinion of the reference laboratory 
and any possible update shall be included in the documentation of the notified body concerning the device. The notified body sha ll give due consideration to the views 
expressed in the scientific opinion when  making its decision. The notified body shall 
not deliver the certificate if the sc ientific opinion is unfavourable; 
3.6. For companion diagnostic intended to be used  to assess the pati ent eligibility to a 
treatment with a specific medicinal produc t, seek the opinion, on the basis of the 
draft summary of safety and performance and the draft instructions  for use, of a one 
of the competent authorities designated by the Member States in accordance with 
Directive 2001/83/EC (hereinafter referre d to as 'medicinal products competent 
authority') or the European Medicines Agen cy (hereinafter referred to as ‘EMA’) on 
the suitability of the device in relation to the medicinal product concerned. Where the 
medicinal product falls exclusively within th e scope of the Annex of Regulation (EC) 
No 726/2004, the notified body shall consul t the EMA. The medicinal products 
authority or the European Medicines Agency  shall deliver its opinion, if any, within 
60 days upon receipt of the valid documentation. This 60-day period may be extended only once for a further 60 days on scientifically va lid grounds. The opinion 
of the medicinal products aut hority or of the EMA and an y possible update shall be 
included in the documentation of the notified body concerning the device. The 
notified body shall give due consideration to the opini on, if any, expressed by the 
medicinal products competent authority concerned or the EMA when making its 
decision. It shall convey its final deci sion to the medicinal products competent 
authority concerned or to the EMA.  
4. Certificate 
If the type conforms to the provisions of th is Regulation, 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 assessme nt, 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 a nd 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 supplement to the initial EU type-examination 
certificate.   
EN 130   EN 5.3. Where the changes could affect compliance with the CTS or with other solutions 
chosen by the manufacturer which were a pproved through the EU type-examination 
certificate, the notified body shall consult th e reference laboratory that was involved 
in the initial consultation, in order to c onfirm that compliance with the CTS, when 
available, or with other solutions chosen by the manufacturer to  ensure a level of 
safety and performance that is at  least equivalent  are maintained. 
The reference laboratory shall provide a scientific opinion within 30 days. 
5.4. Where the changes affect a companion di agnostic approved th rough the EU type-
examination certificate with regard to its  suitability in relation to a medicinal 
product, the notified body shall consult the medicinal products co mpetent authority 
that was involved in the initial consulta tion or the EMA. The medicinal products 
competent authority or the EMA shall give its opinion, if any, within 30 days after 
receipt of the valid documentation regard ing the changes. The approval of any 
change to the approved type shall take the form of a supplement to the initial EU type-examination certificate. 
6. Administrative provisions 
The manufacturer or his authorised  representative shall, for a pe riod ending at least five years, 
after the last device has been placed on the mark et, 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 8 of Annex VIII shall apply.  
EN 131   EN ANNEX X  
CONFORMITY  ASSESSMENT  BASED  ON  PRODUCTION  QUALITY  
ASSURANCE   
1. The manufacturer shall ensure applicati on 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 15 and Annex III 
for the device model covered by the conform ity assessment procedure. By issuing an 
EU declaration of conformity, the manufactur er 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 app lication for assessment of his quality 
management system with a notified body.  
The application 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 examination certifi cates referred 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 cert ificates issued is sufficient.  
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 every stage. All the elements, requirements and provisions adopted by the manufacturer fo r his quality management system shall 
be documented in a systematic and orderly 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 system ensures that the devices  conform to the type described in the in 
the EU type-examination certificate and confor ms 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 
inspection and a reasoned assessment. 
3.4. The provisions of the Secti on 3.4 of Annex VIII apply.   
EN 132   EN 4. Surveillance 
The provisions of Section 4.1, the first, second and fourth indents of Section 4.2, Section 4.3, 
Section 4.4, Section 4.6 and Sec tion 4.7 of Annex VIII apply. 
5. Verification of manufactured devices classified as class D 
5.1. In the case of devices classified as class D, the manufacturer sh all carry out tests on 
the manufactured devices or each batch of  devices. After the conclusion of the 
controls and tests he shall forward to the notified body without delay the relevant 
reports on these tests. Furthermore, the manufacturer shall make the samples of 
manufactured devices or batches of de vices available to the notified body in 
accordance with pre-agreed conditions and modalities which shall include that the 
notified body or the manufacturer, in regular  intervals, shall send samples of the 
manufactured devices or batches of de vices to a reference laboratory, where 
designated in accordance with  Article 78, to carry out appropriate tests. The 
reference laboratory shall inform the notified body about its findings 
5.2. The manufacturer may place the devices on the market, unless the notified body 
communicates to the manufacturer within the agreed time-frame, but not later than 30 days after reception of the samples, a ny other decision, includi ng in particular any 
condition of validity of delivered certificates. 
6. Administrative provisions 
The manufacturer or his authorised  representative shall, for a pe riod ending at le ast five years 
after the last device has been placed on the mark et, keep at the disposal of the competent 
authorities:  
– the declaration of conformity, 
– the documentation referred to in the four th indent of Section 3.1 of Annex VIII, 
– the documentation referred to in the se venth indent of S ection 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 8 of Annex VIII shall apply.  
EN 133   EN ANNEX XI  
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 and, 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 faci lities 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 standa rds / test reports / 
audit report(s); 
10. if applicable, reference to the relevant pa rts of the technical 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 applic able national 
law.  
EN 134   EN ANNEX XII  
CLINICAL  EVIDENCE  AND  POST-MARKET  FOLLOW-UP 
Part A: Clinical evidence  
The demonstration of conformity with the ge neral safety and performance requirements set 
out in Annex I, under the normal conditions of use of the device, shall be based on clinical evidence.  
The clinical evidence includes all the inform ation supporting the scien tific validity of the 
analyte, the analytical performance and, where applicable, the clinical performance of the 
device for its intended purpose as stated by the manufacturer. 
1. S
CIENTIFIC VALIDITY DETERMINATION AND PERFORMANCE EVALUATION  
1.1. Scientific validity determination 
1.1.1.  The scientific validity refers to the associa tion of the analyte to a clinical condition or 
a physiological state. 
1.1.2.  The determination of the scientific validity may not be necessary where the 
association of the analyte to a clinical condition or a physiological state is well 
known, based on available information, such as  peer reviewed literature, historical 
data and experience. 
1.1.3.  For a new analyte and/or a new intended pu rpose, the scientific validity shall be 
demonstrated based on one or a combination of the following sources: 
– information on devices measuring the same analyte with the same intended 
purpose that have marketing history; 
– literature; 
– expert opinions; 
– results from proof of concept studies; 
– results from clinical performance studies. 
1.1.4.  The information supporting the scientific validity of the analyte shall be summarised 
as part of the clinical evidence report. 
1.2. Performance evaluation  
The performance evaluation of a device is the process by which generated data are assessed 
and analysed to demonstrate the analytical pe rformance, and where applicable the clinical 
performance of that device for its intende d purpose as stated by the manufacturer. 
Interventional performance studi es and other clinical performa nce studies involving risks for 
the subjects of the studies shall only be perf ormed once the analytical performance of the 
device has been established and determined to be acceptable.  
1.2.1.  Analytical performance  
1.2.1.1 The analytical performance ch aracteristics are described in point (a) of Section 6(1) of 
Annex I.  
1.2.1.2 As a general rule, the anal ytical performance shall always be demonstrated on the 
basis of analytical performance studies.   
EN 135   EN 1.2.1.3 For novel devices, it may not  be possible to demonstrate trueness since suitable higher 
order reference materials or a suitable comparat ive method may not be available. If there are 
no comparative methods, different approaches may be used (e.g. comparison to some other 
well-documented method, comparison to the compos ite reference method). In the absence of 
such approaches, a clinical performance study comparing test performance to the current 
clinical standard prac tice would be needed. 
1.2.1.4 The analytical performance data shall be su mmarised as part of the clinical evidence 
report.  
1.2.2.  Clinical performance 
1.2.2.1 The clinical performance char acteristics are described in poi nt (b) of Section 6(1) of 
Annex I. 
1.2.2.2 Clinical performance data may not be required for established and standardised 
devices and for devices classifi ed as class A according to the rules set out in Annex VII. 
1.2.2.3 Clinical performance of a device shall be demonstrated based on one or a combination 
of the following sources 
– clinical performance studies; 
– literature; 
– experience gained by rou tine diagnostic testing. 
1.2.2.4 Clinical performance studies shall be performed unless it is duly justified to rely on 
other sources of clinical performance data. 
1.2.2.5 Clinical performance data sh all be summarised as part of  the clinical evidence report. 
1.2.2.6 When the clinical performance evaluatio n includes a clinical performance study, the 
level of detail of the clinical  performance study report referred to in Section 2.3.3 of this 
Annex will vary based on the risk  class of the device determined according to the rules set out 
in Annex VII:  
– For devices classified as class B accordi ng to the rules set out in Annex VII, 
the clinical performance study report may be limited to a summary of the study 
protocol, results and conclusion; 
– For devices classified as class C accordi ng to the rules set out in Annex VII, 
the clinical performance study report sha ll include the method of data analysis, 
the study conclusion and the relevant  details of the study protocol; 
– For devices classified as class D accordi ng to the rules set out in Annex VII, 
the clinical performance study report sha ll include the method of data analysis, 
the study conclusion, the relevant deta ils of the study protocol and the 
individual data points.  
2. CLINICAL PERFORMANCE STUDIES  
2.1. Purpose of clinical performance studies  
The purpose of clinical performance studies is to establish or confirm aspects of device 
performance which cannot be determined by anal ytical performance studies, literature and/or 
previous experience gained by routine diagnos tic testing. This information is used to 
demonstrate compliance with the relevant gene ral safety and performance requirements with 
respect to clinical performan ce. When clinical performance studies are conducted, the data  
EN 136   EN obtained shall be used in the performance eval uation process and be part of the clinical 
evidence for the device. 
2.2. Ethical considerations for cl inical performance studies 
Every step in the clinical performance study,  from first consideration of the need and 
justification of the study to the publication of the results, shall 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 Assembly in Helsinki, Finland, in 1964 
and last amended by the 59th World Medical Association Gene ral Assembly in Seoul, Korea, 
in 2008.  
2.3. Methods for clinical performance studies 
2.3.1.  Clinical performance study design type 
Clinical performance studies sha ll be designed in such a way as  to maximize the relevance of 
the data while minimising potential biases.  The design of the study sh all provide the data 
necessary to address the clini cal performance of the device.  
2.3.2.  Clinical performance study protocol 
Clinical performance studies shall be performe d on the basis of an appropriate 'clinical 
performance study protocol'.  
The clinical performance study protocol shall set out how th e study is intended to be 
conducted. It shall contain information about the study design such as the purpose, objectives, 
study population, description of test  method(s) and interpretation of results, site training and 
monitoring, specimen type, specimen collection, pr eparation, handling and storage, inclusion 
and exclusion criteria, limitations, warning and precautions, data collection/management, data 
analysis, required materials, number of study sites and if applicable, clinical 
endpoints/outcomes, and require ments for patient follow-up. 
In addition, the clinical performance study prot ocol shall identify the key factors which may 
impact the completeness and significance of re sults, such as intended participant follow-up 
procedures, decision algorithms, discrepa ncy resolution process, masking/blinding, 
approaches to statistical analyses, and met hods for recording endpoints/outcomes and, where 
appropriate, communication of test results. 
2.3.3.  Clinical performance study report 
A 'clinical performance study report', signed by a medical practitioner or any other authorised 
person responsible, shall contain documented in formation on the clinical performance study 
protocol, results and conclusions of the c linical performance st udy, including negative 
findings. The results and conclusions shall be transp arent, free of bias and clinically relevant. 
The report shall contain sufficient information to  enable it to be understood by an independent 
party without reference to other documents. Th e report shall also include as appropriate any 
protocol amendments or deviations, and data  exclusions with the appropriate rationale. 
3. CLINICAL EVIDENCE REPORT  
3.1 The clinical evidence report shall contain th e scientific validity data, the analytical 
performance data and, where applicab le, the clinical performance data. If the analytical 
performance data is determined to be sufficient to declare conformity with the general safety and  
EN 137   EN performance requirements set out to in Annex I  without the need for clinical performance data, 
a rationale should be documented and included in the clinical evidence report.  
3.2 The clinical evidence report shall in particular outline: 
– the justification for the approach taken to gather the clinical evidence;  
– the technology on which the device is ba sed, the intended purpose of the device 
and any claims made about the device’ s clinical performance or safety;  
– the nature and extent of the scientific va lidity and the perfor mance data that has 
been evaluated;  
– how the referenced information demons trate the clinical performance and 
safety of the device in question;  
– the literature search  methodology, if a literature revi ew is the approach taken to 
gathering clinical evidence. 
3.3 The clinical evidence 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 surveillance plan referred to in Article 8(5) which shall include  a plan for the device 
post-market follow-up in accordance with Part B of this Annex.  
Part B: Post-market follow-up 
1. Manufacturers shall put in place procedures to  enable them to collect and evaluate 
information relating to the scientific validity, as well as the analytical and clinical performance of their devices on the basis of  data obtained from post-market follow-
up.  
2. Where such information becomes available to the manufacturer, an  appropriate risk 
assessment shall be conducted and the clin ical evidence report shall be amended 
accordingly. 
3. Where changes to devices are necessary, th e conclusion of the post market follow-up 
shall be taken into account for the clinical  evidence referred to in Part A of this 
Annex and for the risk assessm ent referred to in Section 2 of Annex I. If necessary, 
the clinical evidence  or risk management shall be updated and/or corrective actions 
be implemented.  
4. Any new intended purpose of a device shal l be supported by an updated clinical 
evidence report.   
EN 138   EN ANNEX XIII  
INTERVENTIONAL  CLINICAL  PERFORMANCE  STUDIES  AND  
OTHER  CLINICAL  PERFORMANCE  STUDIES  INVOLVING  RISKS  
FOR  THE  SUBJECTS  OF THE  STUDIES 
I. Documentation regarding the application for interventional clinical 
performance studies and other clinical performance studies involving risks for 
the subjects of the studies 
For devices for performance evaluation intended to  be used in the context of interventional 
clinical performance studies or other clinical  performance studies involving risks for the 
subjects of the studies the sponsor shall dr aw up and submit the application in accordance 
with Article 49 accompanied by the doc umentation as laid down below:  
1. Application form 
The application form shall be duly filled  out containing the following information:  
1.1. Name, address and contact details of the sponsor and, if applicable, name, 
address and contact details of his co ntact person established in the Union. 
1.2. If different from the above, name, address and contact details of the 
manufacturer of the device intended  for performance evaluation and, if 
applicable, of his authorised representative. 
1.3. Title of the clinical performance study.  1.4. Single identification number in accordance with Article 49(1). 
1.5. Status of the clinical performance study (e.g. first submission, resubmission, 
significant amendment). 
1.6. If resubmission with regard to same device, previous date(s) and reference 
number(s) of earlier submi ssion(s) or in the case of significant amendment, 
reference to the original submission. 
1.7. If parallel submission for a clinical trial on a medicinal product in accordance 
with Regulation (EU) No [Ref. of future Regulation on clinical trials], 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 performa nce study shall be conducted as part of 
a multicentre/ multinational study at  the time of application.  
1.9. Brief description of the device for performance evaluation (e.g. name, GMDN 
code or internationally recognised nome nclature code, intended purpose, risk 
class and applicable classification rule according to Annex VII). 
1.10 Summary of the clinical performance study protocol. 
1.11. If applicable, informati on regarding a comparator. 
2. Investigator's Brochure  
The investigator's brochure (IB) shall contai n the information on the device for performance 
evaluation that is relevant for the study and ava ilable at the time of application. It shall be 
clearly identified and contain in part icular the following information:   
EN 139   EN 2.1. Identification and description of th e device, including information on the 
intended purpose, the risk classificati on and applicable classification rule 
according to Annex VII, design and manu facturing of the de vice and reference 
to previous and similar ge nerations of the device. 
2.2. Manufacturer's instructions for insta llation, and use, including storage and 
handling requirements, as well as the label and instructions for use to the extent 
that this information is available. 
2.3. Pre-clinical testing and experimental data. 
2.4. Existing clinical data, in  particular the following: 
– relevant scientific literature available relating to the safety, performance, 
design characteristics and intended purpos e of the device and/ or of equivalent 
or similar devices; 
– other relevant clinical data available re lating to the safety, performance, design 
characteristics and intended purpose of e quivalent or similar devices of the 
same manufacturer, including length of ti me on the market and a review of 
performance and safety related issu es and any corrective actions taken. 
2.5. Summary of the risk/benefit analysis and the risk management, including 
information regarding known or foreseeable risks and warnings. 
2.6. In the case of devices that include tissues, cells and substances of human, 
animal or microbial origins detailed information on the tissues, cells and substances, and on the compliance with the relevant general safety and performance requirements and the specific risk management in relation to the 
tissues, cells and substances.  
2.7. Reference to harmonised or other internationally re cognised standards 
complied with in full or in part.  
2.8. A clause that any updates to  the IB or any other rele vant information that is 
newly available shall be brought to th e attention of the investigators. 
3. Clinical performance study protocol , as referred to in Se ction 2.3.2 of Annex XII.  
4. Other information  
4.1. A signed statement by the natural or legal person re sponsible for the 
manufacture of the device for perfor mance evaluation that the device in 
question conforms to the general safe ty and performance requirements apart 
from the aspects covered by the clini cal performance study and that, with 
regard to these aspects, every precauti on has been taken to protect the health 
and safety of the subject. This stat ement may be supported by an attestation 
issued by a notified body. 
4.2. Where applicable according to national law, a copy of the opinion(s) of the 
ethics committee(s) concerned as soon as available. 
4.3. Proof of insurance cover or indemnifi cation 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 arrangements to co mply with the applicable rules on the 
protection and confidentiality of  personal data, in particular:  
EN 140   EN – organisational and technical arrangements that will be implemented to avoid 
unauthorised access, disclosure, dissemina tion, 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 concerned in clin ical performance 
studies; 
– a description of measures th at will be implemented in case of data security 
breach in order to mitigate the possible adverse effects. 
II. Other sponsor's obligations  
1. The sponsor shall undertake to keep available for the competent national authorities any 
documentation necessary to provide evidence for the documentation referred to in Chapter I of this Annex. If the sponsor is not the natura l or legal person respons ible for the manufacture 
of the device intended for performance evalua tion, this 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. 
3. The documentation mentioned in this Annex sha ll be kept for a period of time of at least 
five years after the clinical pe rformance study 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.  
Each Member State shall make provision that this  documentation is kept at  the disposal of the 
competent authorities for the period indicated in  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 141   EN ANNEX XIV  
CORRELATION  TABLE 
Directive 98/79/EC This Regulation 
Article 1(1) Article 1(1) 
Article 1(2) Article 2 
Article 1(3) Number (36) of Article 2 
Article 1(4) - 
Article 1(5) Article 4(4) and (5) 
Article 1(6) Article 1(6) 
Article 1(7) Article 1(4) 
Article 2 Article 4(1) 
Article 3 Article 4(2) 
Article 4(1) Article 20 
Article 4(2) Article 17(1) 
Article 4(3) Article 17(3) 
Article 4(4) Article 8(7) 
Article 4(5) Article 16(6) 
Article 5(1) Article 6(1) 
Article 5(2) - 
Article 5(3) Article 7 
Article 6 -  
Article 7 Article 84 
Article 8 Articles 67 to 70  
Article 9(1) 1st subparagraph Article 40(5) 1st subparagraph 
Article 9(1) 2nd subparagraph Article 40(3) 2nd subparagraph and (4) 2nd 
subparagraph 
Article 9(2) Article 40(2)  
EN 142   EN Article 9(3) Article 40(3) 
Article 9(4) Article 40(7) 
Article 9(5) - 
Article 9(6) Article 9(3) 
Article 9(7) Article 8(4) 
Article 9(8) Article 41(1) 
Article 9(9) Article 41(3) 
Article 9(10) Article 43(2) 
Article 9(11) Article 40(8) 
Article 9(12) Article 45(1) 
Article 9(13) Article 5(2) 
Article 10 Article 23 
Article 11(1) Numbers (43) a nd (44) of Article 2, Article 
59(1) and Article 61(1) 
Article 11(2) Article 59(3) and Article 61(1) 2nd 
subparagraph 
Article 11(3) Article 61(2) and (3) 
Article 11(4) - 
Article 11(5) Article 61(3) and Article 64 
Article 12 Article 25 
Article 13 Article 72 
Article 14(1)(a) Article 39(4) 
Article 14(1)(b) - 
Article 14(2) - 
Article 14(3) - 
Article 15(1) Article 31 and Article 32 
Article 15(2) Article 27  
EN 143   EN Article 15(3) Article 33( 1) and Article 34(2) 
Article 15(4) - 
Article 15(5) Article 43(4) 
Article 15(6) Article 43 (3) 
Article 15(7) Articles 29(2) and Article 33(1) 
Article 16 Article 16 
Article 17 Article 71 
Article 18 Article 73 
Article 19 Article 80 
Article 20 Article 75 
Article 21 - 
Article 22 - 
Article 23 Article 90 
Article 24 -