EU legisation
- EU core regulatory framework
- Medical devices directive (last consolidated version)
- In vitro diagnostic devices directive (last consolidated version)
- Active implantable medical devices directive (last consolidated version)
- Implementing legislation
- EUDAMED database
European Commission medical devices policy
- DG Consumer Affairs medical devices page
- MEDDEV guidance documents
- Borderline and classification guidance
- Consensus statements (e.g. IVD rare blood groups, class I medical devices)
- Interpretative documents (e.g. concept of ‘placing on the market’, demarcation with personal protective equipment directive)
- Vigilance reports
Self regulatory organisations
- Eucomed (medical devices)
- EDMA (in vitro diagnostics)
- COCIR (European Radiological, Electromedical and Healthcare IT Industry)
