Medical Device Regulations in Europe

All regulatory documents shown below were published by the European Parliament or European Commission. Please help us maintain this list by reporting outdated or missing documents.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. This is not a complete list. See the EC website regulatory section pertaining to medical devices.

MDD 93/42/EEC

• CONSOLIDATED Medical Device Directive (93/42/EEC) (Interactive Web page. Downloadable .pdf document of the MDD 93/42/EEC also available.)

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

• Directive 98/79/EC on In Vitro Diagnostic Medical Devices (Interactive Web page. Downloadable .pdf document of the In-Vitro Diagnostic Devices Directive (98/79/EC) also available.)

Vigilance Contact Points

• Vigilance Contact Points Within The National Competent Authorities (opens in a new window - link to EU Commission Website)