Factsheet for healthcare professionals and health institutions : medical devices, change of legislation : what you need to know!
Date: 2019-02-27
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
Subjects: health care profession, medical device, medical diagnosis, medical research, proposal (EU), tin

European 
Commission

Factsheet for  
healthcare professionals 
and health institutions

MEDICAL DEVICES:  CHANGE OF LEGISLATION
What you need to know!

This factsheet is aimed at healthcare professionals and health 
institutions. For a general overview of the impact of the Regulations 
please refer to the Medical Devices1 section on the website of the 
Directorate General for Internal Market, Industry, Entrepreneurship 
and SMEs (DG GROW)2. 

The new Medical Devices Regulation (2017/745/
EU) (MDR) and the new  In Vitro Diagnostic 
Medical  Devices  Regulation  (2017/746/EU) 
(IVDR), adopted in May 2017, will replace the 
existing Medical Devices Directive (93/42/EEC) 
(MDD), the Active Implantable Medical Devices 
Directive (90/385/EEC) (AIMDD) and the In Vitro 
Diagnostic Medical Devices Directive (98/79/
EC) (IVDD).

The publication of the MDR in May 2017 marked 
the start of a 3 year period of transition from 
the MDD and the AIMDD.

The  publication  of  the  IVDR  in  May  2017 
marked the start of a 5 year period of transi-
tion from the IVDD.

Introduction to the Medical Devices Regulation (MDR) and the In Vitro 
Diagnostic Medical Devices Regulation (IVDR)

The new Regulations will create a robust, transparent and sus-
tainable regulatory framework, recognised internationally, that 
improves clinical safety and creates fair market access conditions 
for manufacturers.

In contrast to directives, regulations are directly applicable 
and do not need to be transposed into national law. The MDR 
and the IVDR will therefore reduce the risk of discrepancies in 
interpretation across the EU.

1 

2 

The term ‘devices’ in this document refers to medical devices and in vitro diagnostic medical devices, as well as their accessories. For definitions of what is 
understood to be a device, see Article 2 of the MDR and the IVDR.
https://ec.europa.eu/growth/sectors/medical-devices_en

Internal market, 
Industry,  
Entrepreneurship  
and SMEs

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Both Regulations will come into force gradually over a transition 
period of 3 years (up to May 2020) for the MDR and 5 years (up 
to May 2022) for the IVDR. From these dates the Regulations will 
apply in full. This transition will allow manufacturers and other 
economic operators to prepare for the implementation of the 
Regulations, while healthcare professionals and health institutions 
will have time to learn what will be required from them, notably 
in terms of the traceability of devices.

During the transition period both Regulations will come into force 
gradually, starting with provisions related to the designation of 
Notified Bodies and the ability of manufacturers to apply for new 
certificates under the Regulations.

To avoid market disruption and allow a smooth transition from 
the Directives to the Regulations, several transitional provisions 
are also in place. Some devices with certificates issued under the 
Directives may continue to be placed on the market3 until 27 May 
2024, and made available4 or put into service5 until 27 May 2025.

What does this mean  
in practice?

Certificates delivered by Notified Bodies under the MDD will remain 
valid until their date of validity or for a maximum of 4 years (and 
until 27 May 2024 at the latest, except for some exceptions 
described in MDR Article 120(2)).

Certificates delivered by Notified Bodies under the IVDD will remain 
valid until their expiry dates or until 27 May 2024 at the latest.

Until May 2025, certain devices placed on the market under the 
Directives and certain devices placed on the market under the 
new Regulations will coexist on the market. Both will have equal 
status under the law, and no discrimination in public tenders 
may take place.

Devices that are in stock in health institutions can still be used 
after 2025 until they reach their expiration dates. Furthermore, 
the Regulations do not regulate the further making available of 
devices, including after 25 May 2025, after they have already 
been made available or put into service, for example in the case 
of second-hand sales (MDR and IVDR recital 3).

What has changed?

In general, no requirements from the Directives (MDD, AIMDD 
and IVDD) have been removed; the Regulations (MDR and IVDR) 
add new ones. Compared to the current Directives, the new 
Regulations emphasise a life-cycle approach to safety, backed 
up by clinical data.

  Risk classification of devices and scope  
 of the Regulations

The classification of MDs into four classes (Class I, IIa, IIb, III) 
remains, but the MDR reclassifies certain devices and has a wider 
scope. For example, the Regulation explicitly covers devices for 
cleaning, sterilising or disinfecting other medical devices. The 
Regulation also covers reprocessed single-use medical devices, 
and certain devices with no intended medical purpose (MDR 
Chapter I and Annex XVI).

For IVDs, the biggest change concerns the new risk-based clas-
sification of in vitro diagnostic devices and the role of Notified 
Bodies. Each IVD will now be assigned to one of four risk classes 
(Classes A, B, C or D, the level of risk increasing from A to D) using 
internationally recognised rules (IVDR Article 47 and Annex VIII).

As a result, around 85 % of all IVDs will need Notified Body 
oversight under the IVDR, compared to 20 % previously under 
the IVDD (IVDR Article 48).

Devices or services sold via the internet are now explicitly covered 
by the Regulations (MDR and IVDR Article 6).

These changes could have consequences for the availability of 
medical devices for health institutions. For instance, manufacturers 
may choose to stop the production of certain medical devices. 
Furthermore, if certain medical devices do not get their certificates 
on time these products may become temporarily unavailable. Ask 
your suppliers to inform you in good time about the availability 
of the devices you need.

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4 

5 

‘Placing on the market’ means the first time the device is made available, other than an investigational device (or ‘other than a device for performance study’ 
according to the IVDR), on the Union market (MDR Article 2(28) and IVDR Article 2(21)).
‘Making available on the market’ means any supply of a device, other than an investigational device (or ‘other than a device for performance study’ according to 
the IVDR), 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 (MDR 
Article 2(27) and IVDR Article 2(20)).
‘Putting into service’ means the stage at which a device, other than an investigational device (or ‘other than a device for performance study’ according 
to the IVDR), 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 (MDR 
Article 2(29)and (IVDR Article 2(22)).

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  Clinical investigations (MDR Articles 62  
to 82) and performance studies  
(IVDR Articles 57 to 77)

The rules on clinical investigations for medical devices and perform-
ance studies for in vitro medical devices have been reinforced. 
The new rules describe clearly how these investigations shall be 
designed, notified and/or authorised, conducted, recorded and 
reported. If you are a sponsor or take part in clinical investigations 
or performance studies, please read the relevant articles carefully 
so that you are informed of all the new obligations.

The Regulations require manufacturers to implement post-market 
surveillance follow-up plans. This includes compiling safety reports 
and updating the performance and clinical evaluation throughout 
the life cycle of a device. This could lead to manufacturers calling 
on health institutions to provide more information about their 
experience with their medical devices. Health institutions could 
prepare for this by thinking about convenient ways to gather 
information about their experience with medical devices.

Manufacturers outside the EU market should have a contract with 
an authorised representative inside the EU.

  Obligations and regulatory requirements 

  CE marking of conformity (MDR Article 20 

of economic operators6

and IVDR Article 18)

The Regulations clarify the respective obligations of manufactur-
ers, authorised representatives, importers and distributors (MDR 
and IVDR Articles 10 to 16).

Devices, other than custom-made7 or investigational devices8, 
that are considered to be in conformity with the requirements of 
the Regulations shall bear the CE mark.

For manufacturers, the Regulations add new requirements and 
reinforce existing requirements. Manufacturers have to put systems 
in place for risk and quality management, conduct clinical or 
performance evaluations, draw up technical documentation and 
keep all of this up to date. Manufacturers are also required to 
apply conformity assessment procedures in order to place their 
devices on the market. The level of clinical evidence needed to 
demonstrate the conformity of a device depends on its risk class.

Once they have completed their obligations, manufacturers should 
draw up a declaration of conformity and apply the CE mark to 
their devices:

The Regulations also clarify the distinction between vigilance and 
post-market surveillance. The former includes identifying and 
reporting serious incidents and conducting safety-related correct-
ive actions. It requires direct and efficient cooperation between 
healthcare professionals, health institutions, manufacturers and 
national competent authorities for medical devices. Post-market 
surveillance involves monitoring the available information to 
periodically reconfirm that the benefits of the device continue to 
outweigh its risks.

MDs in Class I and IVDs in Class A, which are the less risky devices, 
generally do not require the involvement of a Notified Body 
(NB) for their placement on the market. All other devices need a 
certificate issued by a Notified Body. In these case the CE mark 
is followed by the number of the NB.

The Regulations add stricter rules for the designation of Notified 
Bodies with evaluators who are independent from manufacturers 
and their devices (MDR/IVDR Chapter IV). All Notified Bodies will 
have to be designated under the Regulations.

Notifies Bodies’ tasks include:

•  assessing the manufacturer’s quality management system;

•  evaluating the technical documentation – sometimes 

together with product sample verification;

• 

issuing CE marking certificates;

•  announced annual surveillance audits;

•  unannounced audits at least every 5 years, with sample 

testing;

•  post-market surveillance review.

The list of designated Notified Bodies can be found on the NANDO 
database.9

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7 

8 
9 

‘Economic operator’ means a manufacturer, an authorised representative, an importer or a distributor (MDR Article 2(35) and IVDR Article 2(28)).
‘Custom-made device’ means any device specifically made in accordance with a written prescription by any person authorised by national law by virtue of that 
person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular 
patient exclusively to meet their individual conditions and needs (MDR Article 2(3)).
‘Investigational device’ means a device that is assessed in a clinical investigation (MDR Article 2(46)).
http://ec.europa.eu/growth/tools-databases/nando/, NANDO (New Approach Notified and Designated Organisations).

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In addition to the evaluation made by the Notified Bodies, certain 
high-risk devices are subject to additional scrutiny of their clinical 
files by an independent expert panel with clinical, scientific and 
technical expertise (MDR Article 54 and IVDR Article 50).

The new Regulations reinforce the responsibilities of national 
competent authorities and the Commission in terms of controlling 
and monitoring devices on the market.

With each implantable device the manufacturer will have to 
deliver implant card-carrying-appropriate information. This card, 
including the patient’s identity, shall be supplied to each patient 
fitted with an implant. Health institutions shall allow rapid access 
to the information contained on the implant card to any patient 
fitted with a device, unless the type of implant is exempt from 
this obligation (currently this includes for example staples and 
dental hardware) (MDR Article 18).

  Traceability

  EUDAMED database

A completely new feature of the Regulations is the unique device 
identification (UDI) system (MDR Article 27 and IVDR Article 24), 
which will apply to all devices placed on the EU market. The UDI 
will be a barcode, a QR code or any other machine-readable code. 
This will enhance the identification and traceability of devices and 
the effectiveness of post-market safety-related activities through 
targeted field safety corrective actions and better monitoring by 
competent authorities. Economic operators shall be able to identify 
any health institution or healthcare professional to which they have 
directly supplied a device (MDR Article 25 and IVDR Article 22).

UDI should also help to reduce medical errors and fight against 
falsified devices. Use of the UDI system should also improve 
purchasing, waste disposal and stock management by health 
institutions and other economic operators; where possible, UDI 
should be compatible with other authentication systems already 
in place in those settings (MDR recital 41 and IVDR recital 38).

  Identification

Unique device identifiers (UDIs) will be used to uniquely and 
unambiguously identify devices, both individually and when 
packaged, or in the case of reusable devices by direct marking 
of the device itself.

Each MD or IVD and, when applicable, each level of their pack-
aging will have a UDI that will be indicated on the labels. UDIs 
will be added to labels in stages but will be completed by 2027, 
depending on the risk class of the device.

For Class III implantable devices, health institutions shall store 
and keep – preferably by electronic means – the UDIs of the 
devices they have supplied, or with which they have been supplied 
(MDR Article 27(9)). The MDR and IVDR invite Member States to 
encourage and to require health institutions to store and keep 
the UDIs of the devices with which they have been supplied. Also, 
Member States shall encourage, and may require, healthcare 
professionals to store and keep the UDIs of the devices with 
which they have been supplied.

The Regulations will increase transparency by making the UDI the 
key to publicly available information on devices and in studies. 
EUDAMED, the new European database for medical devices and in 
vitro diagnostic medical devices, will play a central role in making 
data available and increasing both the quantity and quality of 
data (MDR Article 33 and IVDR Article 30).

The central European database will allow all stakeholders to 
access basic information on MDs and IVDs, such as the identity 
of the device, its certificate, the manufacturer, the authorised 
representative and the importer.

The EUDAMED database (MDR Article 92 and IVDR Article 87) will 
adequately inform the public, including healthcare professionals, 
about:

•  clinical investigation reports on medical devices and perform-
ance study reports on in vitro medical devices, the summaries 
of the main safety and performance aspects of the device, 
and the outcome of the clinical/performance evaluation;

•  field safety notices by manufacturers and certain aspects of 

serious incident reports.

Healthcare professionals can use this information and may expect 
questions from patients about what they have read in EUDAMED.

In addition, Member States shall take appropriate measures, such 
as organising targeted information campaigns, to encourage and 
enable healthcare professionals, users and patients to report to 
the competent authorities on suspected serious incidents occurring 
with devices (MDR Article 87(10) and IVDR Article 82(10)).

  Labelling and instructions for use

In addition, the Regulations improve labelling. New requirements 
aim to make it easier to identify products, find instructions for use, 
and get information about the safety and performance of devices. 
For example, labels will contain new information, along with sym-
bols showing the presence of hazardous or medicinal substances 
(MDR Annex I Chapter III(23) and IVDR Annex I Chapter III(20)).

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  Custom-made devices

A ‘custom-made device’ means any device specifically made in 
accordance with a written prescription by any person authorised by 
national law by virtue of that person’s professional qualifications 
which gives, under that person’s responsibility, specific design 
characteristics, and is intended for the sole use of a particular 
patient exclusively to meet their individual conditions and needs.

The procedure for custom-made devices is described in MDR Article 
52(8) and Annex XIII. As long as a device is shown to be for the 
exclusive use of a particular patient, in accordance with a written 
prescription, to have been manufactured and used according to 
the safety provisions of MDR Annex I, and properly documented, 
it is exempt from other specific requirements of the MDR.

 Nanomaterials

The MDR notes scientific uncertainty about the risks and benefits 
of nanomaterials used in MDs (MDR recital 15), and requires 
manufacturers to take special care when there is ‘high or medium’ 
potential for internal exposure to nanoparticles. Such devices 
should be subject to the most stringent conformity assessment 
procedures, and take into account the opinions of the relevant 
scientific committees. MDR Article 2 (definitions 18 to 21) defines 
nanoparticles, while MDR Article 3 allows the definition to be 
changed in the light of future research.

  Reprocessing of single-use 

medical devices

The MDR allows reprocessing of single-use MDs to enable their 
safe re-use, as long as this is also permitted by national law 
and only in accordance with MDR Article 17. A reprocessor would 
assume all the responsibilities of the original manufacturer of this 
device (MDR Article 17(2)), but Member States may decide to relax 
this rule somewhat for devices that are reprocessed and used 
within a health institution (MDR Article 17(3)) or reprocessed by a 
third party at the request of a health institution (MDR Article 17(4)). 
In these cases the safety and performance of the reprocessed 
device must be equivalent to that of the original, and systems must 
be in place for risk management, process validation, performance 
testing, quality management, incident reporting and traceability. 
Member States may require health institutions to inform patients 
that they are using reprocessed devices. The European Commission 
will publish common specifications to harmonise the practice in 
those Member States where it is allowed.

In general, each device shall be accompanied by the information 
needed to identify it and its manufacturer, and by any safety and 
performance information relevant to the user, or any other person, 
as appropriate. Such information may appear on the device itself, 
on the packaging or in the instructions for use, and shall, if the 
manufacturer has a website, be made available and kept up to 
date on the website.

  Carcinogenic, mutagenic or reprotoxic 

(CMR) substances and endocrine 
disruptors

The MDR foresees that device labels will have to indicate the 
presence of CMR substances or endocrine-disrupting substances 
in medical devices above certain concentrations. This labelling 
requirement does not mean a device is unsafe. The fact that it 
has been CE marked means that both the manufacturer and the 
Notified Body have established a positive benefit-risk ratio (MDR 
Annex I, Chapter II, section 10.4.1)

  In-house devices

The Regulations allow health institutions under certain conditions 
to manufacture, modify and use devices ‘on a non-industrial 
scale’ when equivalent ones are not available commercially 
(MDR and IVDR Article 5). With the exception of the general 
safety and performance requirements set out in MDR/IVDR Annex 
I, in-house devices are exempt from the requirements of the 
Regulations as long as they are not transferred to another legal 
entity. Nevertheless, health institutions should have appropriate 
quality management systems in place; compile documentation 
on the manufacturing process, the design and performance data 
of the devices, including their intended purpose; and review the 
experience gained from the clinical use of the devices and take 
all necessary corrective actions.

This information shall be made available to competent authorities 
on request, and a declaration with certain details should be made 
publicly available.

If healthcare professionals manufacture and use devices that 
do not comply with Article 5 they must follow the same rules as 
manufacturers.

Member States may require that such health institutions submit 
to the competent authority any further relevant information 
about such devices that have been manufactured and used on 
their territory. Member States shall retain the right to restrict the 
manufacture and use of any specific type of such devices and 
shall be permitted access to inspect the activities of the health 
institutions.

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Checklist for preparedness of healthcare institutions

Traceability 

In-house devices / health institution exemption 

Reprocessing of single-use devices 

Clinical investigationS / performance studies

For Class III implantable devices, health institutions shall store 
– preferably by electronic means – the UDIs of the devices they 
have supplied, or with which they have been supplied.

An implant card and information related to the device shall be 
supplied to each patient with an implanted device (MDR Article 18).

Check with your competent authority to ensure you are prepared 
to apply the healthcare institution exemption if you manufacture, 
modify or use medical devices or IVDs in-house.

Check with your national competent authority on national rules 
and prepare for the application of the Common Specifications to 
be published by the European Commission by 2020. 

If the health institution itself is sponsoring or the healthcare pro-
fessional is taking part in a clinical investigation or a performance 
study, it needs to be aware of enhanced obligations. 

Frequently asked questions

For a complete list of frequently asked questions, see the list 
of FAQs from the Competent Authorities for Medical Devices at:

What is the applicable legislation up to the respec-
tive dates of application?

MDR: https://www.camd-europe.eu/wp-content/uploads/ 
2018/05/FAQ_MDR_180117_V1.0-1.pdf

IVDR: https://www.camd-europe.eu/wp-content/uploads/ 
2018/05/FAQ_IVDR_180117_V1.0-1.pdf

When do the Regulations apply?

The Medical Devices Regulation (EU) 2017/745 (MDR) will apply 
from 26 May 2020 and the In Vitro Medical Device Regulation (EU) 
2017/746 (IVDR) will apply from 26 May 2022 – the respective 
Dates of Application.

Some provisions of these Regulations will apply earlier (e.g. 
regarding Notified Bodies and the Medical Device Coordination 
Group). Some will apply later (e.g. regarding UDIs and labelling).

Until the dates of application (DoA), the laws and regulations 
adopted by Member States in accordance with the Directives 
will continue to apply. To allow a smooth transition from the 
Directives to the Regulations, several transitional provisions are in 
place. Some devices with certificates issued under the Directives 
(AIMDD/MDD/IVDD) may continue to be placed on the market until 
27 May 2024 and made available until 27 May 2025. During 
the transition phase, products certified under the Directives and 
products certified under the Regulations will coexist on the market.

Is it possible to place devices on the market that 
are compliant with the Regulations prior to the 
dates of application?

Yes, manufacturers may place compliant devices on the market 
before the end of the transitional period. This applies to devices in 
all risk classes and includes, for example, custom-made devices, 
systems10 and procedure packs11.

10 

11 

‘System’ means a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a 
specific medical purpose (MDR Article 2(11)).
‘Procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific 
medical purpose (MDR Article 2(10)).

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Medical devices that are subject to the clinical evaluation con-
sultation procedure according to MDR Article 54, and IVD Class D 
devices according to IVDR Article 48(6) may not be placed on the 
market before the expert panels have been established, as well 
as the European Union reference laboratories for Class D devices.

Depending on the risk class of the device, conformity assessment 
may involve an appropriate Notified Body. This requirement may 
create further delays before such devices can be placed on the 
market.

Do certificates issued by Notified Bodies under the 
existing Directives remain valid after the dates of 
application of the Regulations?

Yes, certificates will generally remain valid until the end of the 
period indicated on the certificate, or until 27 May 2024, whichever 
is the earlier. After this date there will be no more valid certificates.

17/06/2019 

© European Union, 2019. 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).

https://ec.europa.eu/growth/ 
sectors/medical-devices_en

Funded under the Third EU Health Programme

ISBN: 978-92-76-03182-6    DOI: 10.2873/761339

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