Essentials of European Medical Device Regulatory Affairs - June 2020

Annex IV lists what to include in DOC Content of the DoC (Annex IV): 1 • CompanyName • Registeredtradename /trademark • SRN ifavailable

Content of the DoC continued 6 A statementdeclaring conformityof the devicewithMDR andany other relevant Union legislation 7 Common Specifications 8 • NotifiedBodyNameandnumber • ConformityAssessmentProcedure • Certificate(s) 9 Any additional informationwhere applicable 10 • Placeanddateof issue • Signature • Nameand functionofperson signing • Signed for/onbehalfoff

• EUARnameandaddress (ifapplicable) 2 A statement that theEUdeclarationof conformity is issuedunder the sole responsibilityof themanufacturer 3 BasicUDI-DI 4 • Productand tradename • Unambiguous reference allowing identificationand traceability: EgProduct code, catalogue number Or Ref toBasicUDI-DI 5 Risk classificationof thedevice (AnnexVIII)

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Affix the CE mark

• All devices must bear the CE mark except: • Custom made devices • Investigational devices • Demonstrations at trade fair or similar (disclaimers required) • Affixed to the device or the sterile packaging or the packaging (if not applicable/possible) • Must appear in any instructions for use and any sales packaging • shall be accompanied by the NB number (where applicable) (check NB rules on their logo) • Form of the CE mark per Annex V

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Free movement of goods if comply

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Chapter III

Articles 25-34

Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European data base on medical devices.

AnnexVI

Registration requirements and UDI

• Traceability • Eudamed • UDI • Registering devices

TheOrganisation for Professionals in Regulatory Affairs

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