Regulations and Directives

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

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Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

NO LONGER IN FORCE: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (MDD).

NO LONGER IN FORCE: Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC) (AIMDD).

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (IVDD).

Implementing and Delegated Acts

Communication from the EU Commission Guidelines

Guidance Documents and Standards

Range of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices. The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR. They are drafted in collaboration with interested parties represented in the various groups and denominated by the following format: “MDCG Year-Number-revision”.

The documents on this page are not legally binding. They present a common understanding of how the MDR and IVDR should be applied in practice aiming at an effective and harmonised implementation of the legislation.

Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council.

If you are a manufacturer, you have to follow the 6 steps in this guidance to affix a CE marking to your product.

Information relating to the medical devices regulations with press material, highlights and latest updates.

DOCUMENTS FOR OLD EU DIRECTIVES. The MEDical DEVices (MEDDEV) Guidance Documents have been developed by various working groups on behalf of the European Commission to assist stakeholders in implementing directives related to medical devices (MDD, AIMDD, IVDD).

The MEDDEVs promote a common approach to be followed by manufacturers and notified bodies that are involved in conformity assessment procedures. Although the guidelines are not legally binding, it is expected that the guidelines be followed, ensuring the uniform application of relevant directive provisions.

Consensus statements and Informative Documents have been also published.

Notice to Stakeholders

Supporting Documents

Basic information for Economic Operators regarding MDR and IVDR.

DOCUMENTS FOR OLD EU DIRECTIVES. The Borderline Manual is intended to assist manufacturers in determining whether their product falls within the definition of a medical device laid down in the Council Directive 93/42/EEC concerning medical devices (MDD).

The Guide to the implementation of directives based on the New Approach and the Global Approach (the ‘Blue Guide’) was published in 2000. Since then, it has become one of the main reference documents explaining how to implement the legislation based on the New Approach, now covered by the New Legislative Framework.

Information Systems

The New Approach Notified and Designated Organisations (NANDO) database provides information on notified bodies responsible for assessing the conformity of goods which are placed on the market in the EU. Lists of Notified Bodies can be searched on the NANDO web site.

List of European Notified Bodies that have been designated under the EU MDR.

List of European Notified Bodies that have been designated under the EU IVDR.

Other Working Groups

The European Union (EU) Competent Authorities for Medical Devices (CAMD) project was established to enhance collaborative working, communication and surveillance of medical devices across Europe.

CAMD is an umbrella group, under which the national competent authorities in the EU work to enhance the level of collaborative work in what is a single market for medical devices.

Notified Body Operations Group (NBOG) documents are intended to improve the overall performance of Notified Bodies in the medical devices sector by primarily identifying and promulgating examples of best practice to be adopted by both Notified Bodies and those organisations responsible for their designation and control.