Notification pressure for IVDs:
Manufacturers placing a device on the European market have to notify the Competent Authority of the EU Member State where they have their Registered address.
For non-EU manufacturers: Appoint a European Authorized Representative established within the European Union, which will Notify towards the EU CA where they have the Registered Address.
- The Directive: IVDD 98/79/EEC
- Path to EU Market Entry
- Pre-Market Notification
- Notified Body
- Authorized Representative
- Risks of Non-Compliance
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