Active Implantable Medical Devices Directive
PROPOSAL FOR A COUNCIL DIRECTIVE ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE ELECTROMEDICAL EQUIPMENT
- Stage
- In force
- Transposition deadline
- 31 Dec 1992
- Procedure
- Directive
- Last activity
- 20 Jun 1990
Delegated and implementing acts beneath it
By status: 1 published.
| Act | Kind | Status | Adoption |
|---|---|---|---|
| Commission Delegated Regulation (EU) 2016/1178 | Implementing · Decision | Published | Q1 2020 |
Titles link to EUR-Lex where the act has been published.
Summary
GeneratedThe Active Implantable Medical Devices Directive (90/385/EEC) harmonizes EU rules for active implantable electromedical devices, requiring CE marking via conformity assessment procedures and compliance with essential requirements. It applies to manufacturers, authorized representatives, and notified bodies, covering devices like pacemakers and implantable defibrillators.
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