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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

Applicable until 25.05.2021

Modification:

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

OJ L 117 of 5 May 2017

Applicable from 26.05.2021

See references published under Regulation (EU) 2017/745 on Medical Devices

Guide for application:

European Commission contact point:

Directorate-General for Health and Food Safety
Medical devices
SANTE-MED-DEVatec [dot] europa [dot] eu (Email)
Webpage on medical devices

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

The references published under Directive 90/385/EEC on active implantable medical devices are found in the Commission implementing decision listed below. The decision applies until 26 May 2024.

Publications

Publications in the Official Journal

Commission Implementing Decision (EU) 2020/438 of 24 March 2020 on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC - OJ L 90I , 25 March 2020

Consolidated text: Commission Implementing Decision (EU) 2020/438 of 24 March 2020

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