The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively
- 1998: Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices (IVDMD)
- 1993: Council Directive 93/42/EEC on Medical Devices (MDD)
- 1990: Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD)
Implementing measures for directives
The European Commission has adopted several implementing measures based on the medical devices directives.
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.
You will find a list of key documents, including recommendations, classification and other amending and implementing legislation.
Guidance
The Commission provides a range of legally non-binding guidance documents to assist stakeholders in implementing directives related to medical devices with the objective of ensuring uniform application of the relevant provisions of the directives within the:
Guidance and implementing measures adopted under the Directives are being reviewed in the light of the texts of the 2 new regulations. See new regulations and guidance for new regulations for more information.
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.
For that, European Databank on Medical Devices (Eudamed2) provides national competent authorities with fast access to information. It also contributes to a uniform application of the Directives. See more via the Market Surveillance and Vigilance page.
Plan for Immediate Actions (PIP Action Plan)
The European Commission and EU countries have taken joint action to tighten controls, provide a better guarantee for the safety of medical devices, and restore confidence as part of the Joint Plan for Immediate Actions under existing Medical Devices Legislation, the so-called PIP Action Plan.
Notified bodies
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 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.
- List of notified bodies under Directive 90/385/EEC on active implantable medical devices
- List of notified bodies under Directive 93/42/EEC on medical devices
- List of notified bodies under Directive 98/79/EC on in vitro diagnostic medical devices
Harmonised European standards
Harmonised European standards under the medical devices Directives are developed by CEN and Cenelec as European standardisation organisations, on the basis of specific mandates 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 Directives they aim to cover.
The latest lists of references of harmonised European standards under the medical devices Directives published in the OJ are available on the standardisation webpages on healthcare engineering: Active implantable medical devices, Medical devices, In vitro diagnostic medical devices.
