Essentials of European Medical Device Regulatory Affairs

Sign the declaration of conformity DoC

By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance with the requirements of this Regulation and all other Union legislation applicable to the device • Declared by the manufacturer- sole responsibility • Clearly identified device(s) sizes /variants • Sign only once the technical documentation is complete and necessary CE certificates received • Retain for at least 10 years after the last device • Copy to importers, distributors and AR • Continuously update (article 19) • Translated into at least one EU language

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Sign the DoC

Content of the DoC (Annex IV): 1 • Company Name • Registered trade name /trade mark • SRN if available • EUAR name and address (if applicable) 2 A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer 3 Basic UDI-DI 4 • Product and trade name • Unambiguous reference allowing identification and traceability: Eg Product code, catalogue number Or Ref to Basic UDI-DI 5 Risk classification of the device (Annex VIII)

Content of the DoC continued 6 A statement declaring conformity of the device with MDR and any other relevant Union legislation 7 Common Specifications 8 • Notified Body Name and number • Conformity Assessment Procedure • Certificate(s) 9 Any additional information where applicable 10 • Place and date of issue • Signature • Name and function of person signing • Signed for/on behalf off

The Organisationfor Professionals inRegulatory Affairs