Internal Market, Industry, Entrepreneurship and SMEs

Active implantable medical devices

Active implantable medical devices

Directive 90/385/EEC

Short name:

Active Implantable Medical Devices

Base:

Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
OJ No L 189 of 20 July 1990

Modification:

  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
  • Directive 93/68/EEC [CE Marking]
  • Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Directives repealed:

76/117/EEC
79/196/EEC (as at last amended by Directive 90/487/EEC)
82/130/EEC

Guide for application:

European Commission contact point:

Directorate-General for Health and Food Safety
Medical devices
Email
Webpage on medical devices

For information about the content and availability of European standards, please contact the European Standardisation Organisations.

Since 1 December 2018 the references of harmonised standards are published in, and withdrawn from the Official Journal of the European Union by means of 'Commission implementing decisions'.

The references published under Directive 90/385/EEC on active implantable medical devices are found in Commission Implementing Decision (EU) 2020/438 of 24 March 2020 (OJ L 90I , 25 March 2020) listed below. The decision applies until 26 May 2024.