Scope and legal context
Directive 90/385/EEC is the former framework for active implantable medical devices. Its reference collection supports the reading of historical technical files and certificates. Current regulatory planning belongs under the Medical Devices Regulation (EU) 2017/745; the existence of an old standard citation does not establish eligibility for a legacy-device transition.
Status and transition
Historical framework: the directive ceased to be the general placing-on-the-market basis on 26 May 2021. Any continued legacy-device route must satisfy MDR Article 120 as amended.
Questions for the product review
- Was the device lawfully covered by the former directive before the MDR application date?
- Does the certificate, intended purpose and device configuration remain within a valid transitional route?
- Which implant, external components and software versions does the evidence identify?
Evidence to examine
- Keep the former certificate, declaration and notified-body scope together with evidence of the applicable MDR transitional conditions.
- Connect implant reliability, biological evaluation and powered functions with the actual implant system and accessories.
- Distinguish a historical harmonised-standard reference from the current MDR standards collection.
Official sources
- European Commission: Active implantable medical devices (Directive 90/385/EEC)
- Council Directive 90/385/EEC
- Medical Devices Regulation (EU) 2017/745
- MDR transitional amendment: Regulation (EU) 2023/607
Sources checked: 20 October 2026
Check the governing act, its amendments and the exact standard citation together. The source list can contain earlier editions or historical framework records.
Standard reference records
49 indexed reference strings are linked to this source collection, including historical entries.