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Regulatory notes
Notes on Article 11, EUDAMED registration and market access — written by the team that files the records.
Frequently asked questions
Authorised representation
If your company is established outside the European Union and you place medical devices or in vitro diagnostics on the EU market, yes. Article 11(1) of the MDR and IVDR makes it a condition of market access. The appointment must be in writing and in place before the device enters the market.
Appoint a representative
Send your device list for a written quote
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