Medical Device Regulations in Europe

Europe

All regulatory documents shown below were published by the European Parliament or European Commission and are in PDF format. Please help us maintain this list by reporting outdated or missing documents. If you need help determining the regulatory requirements for your medical device in Europe, you may be interested in our custom regulatory strategy reports for Europe.

MDD 93/42/EEC

In-Vitro Diagnostic Devices Directive (98/79/EC)

Vigilance Contact Points

General Guidance Documents

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