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European Union

Key laws, acts, regulations, directives, guidelines, guidance documents, standards and other relevant resources for business development and regulatory professionals in the medical industry.

EU MDR 2017/745

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

EU IVDR 2017/746

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

EU MDD 93/42/EEC

NO LONGER IN FORCE: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (MDD).

EU AIMDD 90/385/EEC

NO LONGER IN FORCE: Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC) (AIMDD).

EU IVDD 98/79/EC

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

EU MDR 207/745 Implementing acts

Implementing and Delegated Acts

Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745 2020/C 171/01

Communication from the EU Commission Guidelines

MDCG Guidance Documents

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.

Harmonized Standards

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.

Guidance on CE marking for professionals

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

Guidelines related to medical devices regulations

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

MEDDEV Guidance Documents

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).

Notice to Stakeholders

Commission publishes information notice on the status of the EU-Switzerland Mutual Recognition Agreement for Medical Devices

EU Commission Factsheets

Basic information for Economic Operators regarding MDR and IVDR.

Manual on borderline and classification in the community regulatory framework for medical devices

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).

Blue Guide

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.

NANDO Information System

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.

NANDO MDR database

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

NANDO IVDR database

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

CAMD

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.

NBOG

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.

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