Factsheet for  
Manufacturers  
of Medical Devices
What you need to know!MEDICAL DEVICES  CHANGE OF LEGISLATION
This Factsheet is aimed at manufacturers of medical devices. 
For a general overview of the impact of the In-Vitro   Medical 
Devices Regulation (IVDR) on manufacturers see the Factsheet 
for manufacturers of in-vitro diagnostic medical devices. Refer -
ences to  Annexes and Articles in this factsheet refer to the MDR 
(2017/745/EU).
The new Medical Devices Regulation 
(2017/745/EU) (MDR) and the In-vitro 
Diagnostic Medical Devices Regulation 
(2017/746/EU) (IVDR) bring EU legislation 
into line with technical advances, chang -
es in medical  science, and progress in law 
making.
The new Regulations will create a robust, 
transparent, and sustainable regulatory 
framework, recognised internationally, that 
improves clinical safety and creates fair 
 market access for manufacturers.
In contrast to Directives, Regulations do 
not need to be transposed into national 
law. The MDR and the IVDR will therefore 
reduce the risks of discrepancies in inter -
pretation across the EU market.
Transitional periods are planned to smooth 
the application of the new Regulations. 
However, you should bear in mind that con -
sultants, in-house professionals, and Notified 
Bodies will all get busier as the deadline 
draws closer. 
Act now to be ready on time!       Medical Devices Regulation  
   (MDR) background
The MDR will replace the existing Medical Devices Directive (93/42/EEC) 
(MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) 
(AIMDD). The MDR was published in May 2017, marking the start of a 
three-year period of transition from the MDD and the AIMDD.
During the transitional period the MDR will come into force gradually, start -
ing with the provisions related to the designation of Notified Bodies and 
the ability of manufacturers to apply for new certificates under the MDR.
The transitional period will end on 26 May 2020, the “Date of Application” 
(DoA) of the Regulation. From that date the MDR will apply fully.
1
Internal market, 
Industry,  
Entrepreneurship  
and SMEs
Ref. Ares(2018)3873669 - 20/07/20182To avoid market disruption and allow a smooth transition from 
the Directives to the Regulation, several transitional provisions 
are in place (Article 120). Some devices with certificates issued 
under the Directives (AIMDD/MDD certificates) may continue to 
be placed on the market until 27 May 20241, and made avail -
able until 27 May 20252 .
During the transition phase, products certified under the Direc -
tives and products certified under the Regulation will coexist on 
the market. Both will have equal status under the law, and no 
discrimination in public tenders may take place.
   What has changed?  
In terms of their impacts on manufacturers and products, the 
Directives and the MDR largely share the same basic regulatory 
requirements. No existing requirements have been removed, but 
the MDR adds new requirements.
Compared to the current Directives, the MDR places more em -
phasis on a life-cycle approach to safety, backed up by clinical 
data.
The MDR brings more stringent requirements for the designation 
of Notified Bodies, with increased control and monitoring by the 
national competent authorities and the Commission.
The MDR reclassifies certain devices and has a wider scope. 
For instance, the MDR explicitly covers all devices for cleaning, 
sterilising or disinfecting other medical devices (Article 2.1); re -
processed single-use medical devices (Article 17)3; and certain 
devices with no intended medical purpose (Annex XVI).
The MDR also covers internet sales of medical devices and med -
ical devices used for diagnostic or therapeutic services offered 
at a distance (Article 6).
The MDR introduces a clinical evaluation consultation procedure 
for some Class IIb devices and for implantable Class III devices 
by an independent expert panel (Article 54).
A new Unique Device Identification system (Article 27) will 
significantly enhance the traceability and the effectiveness of 
post-market safety-related activities.
The MDR will also provide increased transparency, with infor -
mation on devices and studies being made public. The new Eu -
ropean Database for Medical Devices – Eudamed – will play a 
central role in making data available and increasing both the 
quantity and quality of data (Article 33).
1  For definition see Article 2 paragraph 282
2  For definition see Article 2 paragraph 27
3  Reprocessing and further use of single-use devices may only take place where permitted by national law and only in accordance with this Article.  
4  EEA: European Economic Area   What does this mean  
   in practice?
Scope (Article 1)
The scope of the MDR has broadened, so as a manufacturer you 
must check your product portfolios to find out whether more of 
your devices fall within the scope of the Regulation compared 
to the Directives. Pay attention to products listed in Annex XVI, 
which will be covered by the Regulation once the respective Im -
plementing Regulation setting out common specifications has 
been adopted. The list of products excluded from the scope can 
be found in paragraph 6. Some products that combined a medi -
cal device and an in-vitro diagnostic device or a medicinal prod -
uct follow specific rules (see paragraphs 7, 8, 9).
It is now explicit that devices and services sold online fall under 
the scope of this Regulation (Article 6).
Definitions (Article 2)
The definition of a medical device has been slightly modified 
and there are more definitions of terms in the Regulation than in 
the Directives, in order to ensure a common understanding at EU 
level. Examples include: Unique Device Identifier (Definition 15), 
clinical data (Definition 48), clinical evidence (Definition 51), and 
serious incident (Definition 65).
Obligations of manufacturers
The obligations of the different actors and their relations are 
now clearly stated in the Regulation.
According to Article 10, manufacturers shall have systems 
for risk management (paragraph 2) and quality management 
(paragraph 9); conduct clinical evaluations (paragraph 3); com -
pile technical documentation (paragraph 4); and apply a confor -
mity assessment procedure (paragraph 6). Manufacturers are 
also responsible for their devices once they are on the market 
(paragraphs 12, 13, 14). They must have systems in place to 
cover their financial responsibility for harm caused by defective 
devices (paragraph 16).
Every manufacturer shall have a named person responsible for 
regulatory compliance (Article 15).
Manufacturers of some implantable devices will have to provide 
an implant card for the patient (Article 18).
Once they have completed all these obligations, manufacturers 
shall draw up a declaration of conformity (Article 19) and apply 
CE marking to their devices (Article 20).
Manufacturers outside the EU/EEA shall have a contract with an 
authorised representative inside the EU/EEA4 (Article 11).3The obligations of authorised representatives (Article 11), 
 importers (Article 13) and distributors (Article 14) are also 
 clearly described.
Risk classes of devices
As a manufacturer you must check your portfolio of products 
to determine whether some of your devices will be reclassified 
or will need to be scrutinised by a Notified Body. Determining 
the risk class of a medical device is essential in specifying the 
steps required for CE marking (Article 51), especially in terms 
of the choice of conformity assessment procedure and clinical 
requirements.
The MDR sets out 22 rules for determining risk classes (Annex 
VIII), compared to 18 rules under the Directive. You should pay 
special attention to rules regarding: invasive devices, surgically 
invasive devices and implantable devices (Section 5: Rules 5 to 
8); active devices (Section 6: Rules 9 to 13, for example, soft -
ware now falls under Rule 11); devices utilising tissues and cells 
(Rule 18); devices incorporating nanomaterials (Rule 19); and 
devices composed of substances (Rule 21).
Notified Bodies (Chapter IV)
Notified Bodies have to be designated under the new Regula -
tion. They will be required to meet more stringent criteria, par -
ticularly in terms of clinical competence. Notified Bodies can 
apply to be designated from 26 November 2017. The process 
of designation, which might take 12 months or more, involves 
assessors from different national and European authorities. This 
means that the first Notified Bodies designated under the new 
Regulation might be available by the end of 2018.
The database of Notified Bodies (NANDO) can be found here.
http://ec.europa.eu/growth/tools-databases/nando/
As a manufacturer you must verify whether your Notified Body 
will be designated under the new Regulation and whether the 
scope of its designation will cover all your products. You must 
also start working with your Notified Body to plan the timing 
of certification for your product portfolio, taking into account 
the availability of your Notified Body, the need for additional 
data on devices and the transitional provisions in the new 
Regulation.
Device identification
A system of unique device identifiers (UDIs) will enhance the 
identification  (Article 27)  and traceability (Article 25) of MDs. 
This is a completely new feature of the Regulation.
Each MD – and as applicable, each package – will have a UDI 
composed of two parts: a device identifier (UDI-DI) specific to a 
device, and a production identifier (UDI-PI) to identify the unit 
producing the device.Manufacturers are responsible for entering the necessary data 
on the European database (Eudamed), which includes the UDI 
database, and for keeping it up to date.
Conformity assessment (Chapter V Section 2)
The assessment of the conformity of a device for CE marking 
varies according to the risk class and specific features of certain 
devices (Article 52). The intervention of a Notified Body is need -
ed for all Class IIa, IIb and III devices, as well as some specific 
Class I devices (see paragraphs 7a5, b6, and c7). The different 
routes of assessment according to the class of the device are 
described in Article 52 and the Annexes IX, X, XI. In some cases 
manufacturers have some choice regarding the conformity as -
sessment route.
For certain Class III and Class IIb devices there is a new clinical 
evaluation consultation procedure to be carried out by an inde -
pendent expert panel, based on the clinical evaluation assess -
ment report of the Notified Body (Article 54).
Annex I specifies the general safety and performance require -
ments, while Annexes II and III specify the makeup of the tech -
nical documentation.
The scope of the Quality Management System (Article 10 para -
graph 9) now includes clinical evaluation and post-marketing 
clinical follow-up (PMCF). A clinical evaluation plan must pre -
cede the clinical evaluation itself (Annex XIV, Part A).
Common specifications defining additional requirements may be 
put in place for certain devices (Article 9).
Clinical requirements (Chapter VI)
The new Regulation reinforces the requirements for clinical 
evaluation (Article 61), introducing some of the biggest changes 
compared to the previous regime.
As under the Directives, it includes the collection of clinical data 
already available in the literature as well as the setting up of 
any necessary clinical investigations. The concept of equiva -
lence with other devices for which clinical data already exists 
can still be used, but only in a limited number of situations, and 
the new rules are tighter (Article 61 paragraphs 4, 5, 6).
Article 62 and Annex XV set out the new and more precise re -
quirements for clinical investigations. With only certain excep -
tions, implantable and Class III medical devices must now go 
through clinical investigations.
For all Class III devices, and for Class IIb devices intended to 
administer a medicinal product (or remove it from the body), 
the manufacturer has the option to consult a group of European 
experts to obtain an upstream review of its intended clinical de -
velopment strategy (Article 61 paragraph 2).
5 “Devices placed on the market in sterile condition, to the aspects relating to establishing, securing and maintaining sterile conditions”.
6 “Devices with a measuring function, to the aspects relating to the conformity of the devices with the metrological requirements”.
7 “Reusable surgical instruments, to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization,  
 maintenance and functional testing and the related instructions for use”.4Summary of safety and clinical performance  
(Article 32)
For Class III and implantable devices, manufacturers shall draw 
up a summary of their safety and clinical performance in a form 
that intended users (and patients, if relevant) can understand. 
This summary will form part of the technical documentation 
sent to the Notified Body
   Timing your transition  
                  to the new Regulation
As a manufacturer, the timing of your transition to the MDR is 
up to you.
From 26 May 2020, all new certificates will have to be delivered 
according to the Regulation. The certificates delivered under the 
Directives can be valid until their date of validity for a maximum 
of four years (27 May 20248 at the latest). However, in the latter 
case, the requirements of the new Regulation relating to post-mar -
ket surveillance, market surveillance, vigilance, and the registration 
of economic operators and devices shall apply from the Date of 
Application (Article 120 paragraph 3).
Class I devices (other than those that have a valid certificate 
under the Directive) will have to conform to the new Regulation 
from 26 May 2020.
Class I (except sterile devices, devices with a measuring func -
tion and reusable surgical instruments) and Class IIa might be 
easiest to start with. Classes IIb and III will be more challenging 
because of the more stringent requirements for clinical data.
As a manufacturer, you can start now by making sure that:
1. all your products are classified appropriately;
2. all product documentation and evidence of compliance will 
be available in a timely fashion and conforms with the 
MDR; and
3. you have the necessary systems in place to handle clinical 
evaluation, quality management, post-market surveillance, 
and liability for defective devices.
More information
For more information on any of the above topics, please refer to 
the Medical Devices section  on the DG GROW website.
https://ec.europa.eu/growth/sectors/medical-devices_en         Frequently asked  
   questions
Below you can find an extract from the FAQs of the Competent 
Authorities for Medical Devices. For a complete list, see: 
http://www.camd-europe.eu/sites/default/files/media/docu -
ments/FAQ_MDR_180117_V1.0.pdf .
When does the Medical Devices Regulation (MDR) 
apply?
The MDR (EU) 2017/745 will apply from 26 May 2020 – the 
“Date of Application” (DoA).
Some provisions of the MDR will come into force earlier (e.g. 
regarding Notified Bodies and the Medical Device Coordination 
Group). Some will apply later (e.g. regarding UDI labelling).
When do the existing Directive cease to apply?
In general, Directives 90/385/EEC and 93/42/EEC will be  
repealed on 26 May 2020 (the DoA). However, there are some 
exceptions, such as:
• for the continued marketing of devices that comply with the 
Directives (see below); and
• to serve as a backup in case Eudamed is not fully functional 
by the DoA.
What is the applicable legislation up to 26 May 2020?
Until the Date of Application, the laws and regulations adopted 
by Member States in accordance with the Directives will contin -
ue to apply. However, there are some exceptions.
Is it possible to place devices on the market that 
are compliant with the MDR prior to the DoA?
Yes, you may certainly place MDR-compliant devices on the 
market before the end of the transitional period. This applies 
to devices in all risk classes, and includes, for example, cus -
tom-made devices, systems and procedure packs.
However, devices subject to the “clinical evaluation consultation 
procedure”, which covers certain devices in Classes IIb and III, 
may not be placed on the market before the Medical Device 
Coordination Group (MDCG) and the expert panels have been 
established.
Depending on the risk class of the device, conformity assess -
ment may involve an appropriate Notified Body. This require -
ment may create further delays before such devices can be 
marketed due to the delays in the availability of appropriate 
Notified Bodies for all technologies.
8 There are some exceptions described in Article 120 paragraph 25As a manufacturer, which obligations of the Regulation 
do I need to fulfil in order to place compliant devices 
on the market before the DoA?
You should meet as many obligations as possible, bearing in 
mind that the complete MDR infrastructure, including Eudamed, 
is unlikely to be complete before the Date of Application.
Both the device and the manufacturer must comply with the 
MDR. You should assess the conformity of your device – a pro -
cess that may require the involvement of a Notified Body. Other 
important points include:
• Clinical evaluation
• Risk management
• Quality Management System (QMS)
• Post-market surveillance
• Technical documentation and other reports
• Liability for defective devices.
Until Eudamed is fully operational, some parts of the Directives 
will have to substitute for the corresponding requirements of 
the Regulation. These include the registration of devices and 
economic operators.
A person responsible for regulatory compliance needs to be 
available but not necessarily registered until Eudamed is 
 operational.
Do certificates issued by Notified Bodies  
under the existing Directives remain valid  
after the DoA?
Yes, AIMDD/MDD certificates will generally remain valid un -
til their indicated expiry dates. This applies to all the certifi -
cates commonly issued by Notified Bodies, including the EC 
Design- Examination Certificates, Certificates of Conformity, EC 
Type  Examination Certificates, the EC Certificate Full Quality 
 Assurance System, and the EC Certificate Production Quality 
 Assurance.However, all certificates issued after 25 May 2017 will be void 
at the latest by 27 May 2024. After this date there will be no 
more valid AIMDD/MDD certificates.
Is it possible to have valid MDR and AIMDD/MDD 
certificates in parallel until 27 May 2024?
Yes.
Can manufacturers still place on the market/put 
into service Directive-compliant devices after the 
end of the transition period?
Yes, under certain conditions there will be an option to con -
tinue placing on the market/putting into service devices that 
comply with the Directives until their existing certificates ex -
pire. This may avoid the immediate need for a new certificate 
under the MDR.
To use this option, all the existing certificates will have to be val -
id (including, for example, the QMS), the purpose and nature of 
the device must not change, and you must follow the new MDR 
rules for registration, surveillance and vigilance.
What is the “sell-off” provision about? 
The “sell-off” provision is intended to limit the time during which 
devices that are compliant with the Directives and have already 
been placed on the market may be made available. 
Any devices that are still within the supply chain and that have 
not reached their final user as being ready for use, for example 
a hospital, on 27 May 2025 are no longer marketable and must 
be withdrawn. 
Once a Directive-compliant device has been made available to 
the final user by the deadline, the further making available of 
this device is not subject to/covered by the Regulation.
© European Union, [2018]  Reuse is authorised provided the source is acknowledged.
The reuse policy of European Commission documents is regulated by Decision 2011/833/EU (OJ L 330, 14.12.2011, p. 39).
ISBN: 978-92-79-89634-7    DOI: 10.2873/614436
ET-03-18-102-EN-N