Essentials of European Medical Device Regulatory Affairs - October 2019

• 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

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