Implementation of EU Medical devices & IVDs Legislation
The European Commission has adopted several implementing measures based on the EU legislative acts on Medical Devices. These measures concern, among other things, medical devices manufactured using tissues of animal origin, the classification of certain medical devices, and common technical specifications for in vitro diagnostic devices (IVDs), listed in annex II of the IVD directive. In addition, the EU Commission charged CEN and CENELEC to create harmonised European Standards, created NANDO system and EU watches over counterfeits.
The European Commission has adopted several implementing measures based on the EU legislative acts on Medical Devices. These measures concern, among other things, medical devices manufactured using tissues of animal origin, the classification of certain medical devices, and common technical specifications for in vitro diagnostic devices (IVDs), listed in annex II of the IVD directive. In addition, the EU Commission charged CEN and CENELEC to create harmonised European Standards, created NANDO system and EU watches over counterfeits.
Implementing Decisions & Regulations
Legislative Act (consolidated) |
Amending |
Repealing |
Fully applicable |
Implementing Decisions/Regulations |
Regulation (EU) 2017/745 on medical devices (MDR), |
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Council Directives:
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26 May 2021 |
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26 May 2022 |
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Check the "Implementation Rolling Plan" of the European Commission, that contains a list of identified essential implementing acts and other relevant initiatives that the Commission has adopted or intends to adopt in the future.
In addition, there is a:
In addition, there is a:
- Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices
How to comply with EU rules
Dedicated factsheets provide a summarised view of the main areas of activities in the medical devices sector.
Click & Check how to comply with EU rules
Guidance to assist the stakeholders
The European Commission provides a number of legally non-binding guidance documents to assist interested parties in the implementation of the EU Directives relating to medical devices, with the aim of facilitating the uniform application of the relevant provisions of the directives in the field from:
Harmonised European standards
Harmonised European standards under the medical devices Regulations are developed by CEN and CENELEC, the two European standardisation organisations (mandates are issued by the Commission, according to Regulation (EU) 1025/2012). Once their references are published by the Commission in the Official Journal of the European Union, the voluntary use of those standards confer presumption of conformity with the requirements of the Regulations they aim to cover.
Lists of references of harmonised European standards:
NANDO: The Notified bodies Information System
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A "notified body" is an organisation designated by an EU Member State (or by other countries under specific agreements) to assess the conformity of certain products to the harmonised european standards before being placed on the market. These bodies are entitled to carry out tasks related to conformity assessment procedures set out in the applicable legislation when the intervention of a third party is required. The Commission publishes a list of such notified bodies in the NANDO information system. Follow the link on the side to find a Notified Body in NANDO database and the Medical Device Conformity Assessment Procedures for which it is authorized. |
Click to access
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Counterfeiting
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The EU fights against counterfeiting of healthcare products, as it endangers the safety and health of patients. Counterfeiting occurs with incorrect labeling with respect to the identity of the product and its origin. Consequences of counterfeiting:
The Commission has published a study on distribution channels dealing with counterfeiting problems. The goal is to assist and encourage the development and implementation of government policies and regulations that combat and deter the manufacture and trade of counterfeit medical devices. |
Click to read
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EUDAMED database of the medical devices available in EU: Market Surveillance and Vigilance
The Medical Devices Directives establish specific procedures that national authorities must follow when considering the enforcement of the harmonised legislation. In addition, the Medical Device Vigilance System aims at preventing the repetition of incidents related to the use of a medical device.
European Databank on Medical Devices EUDAMED, the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices, provides national competent authorities with fast access to information on medical devices available on the EU market. It also contributes to a uniform application of the Directives. See more via the Market Surveillance and Vigilance page.
Click to access the public database consultation
Note: from 1 December 2020, every economic operator for medical devices that wants to work in the European market (EU and non-EU manufacturers, authorised representatives, system/procedure pack producers and importers) must register as an actor in EUDAMED, providing the requested information. Then, you will receive a "Actor Identifier"/"Unique Registration Number", which is required for your identification if you are active in the EU market. Click here to start your registration to EUDAMED.
However, the EU Commission is not in a position to require the use of the Actor registration module until EUDAMED is fully functional according to the Medical Device Regulation and additional national requirements on registrations can therefore not be excluded.
However, the EU Commission is not in a position to require the use of the Actor registration module until EUDAMED is fully functional according to the Medical Device Regulation and additional national requirements on registrations can therefore not be excluded.
