Essentials of European Medical Device Regulatory Affairs - June 2020

Importer Obligations

• Check compliance to MDR • Check product is registered in electronic system • Forward complaints and AEs to manufacturer and AR • Provide samples to competent authorities if necessary • Repacking is possible – article 16

Distributor Obligations • Check product is CE marked and has a declaration of conformity • Has the correct labelling • That the importer has done necessary tasks • And that a UDI is assigned • Forward complaints and AEs to manufacturer and AR • Provide documents to competent authorities if necessary

37

Single –use devices

•The re-processor becomes the manufacturer

Implant cards • Needs to be provided to the patient • Identify the device • Warnings and precautions • Expected lifetime of the device • Some implants exempt e.g. tooth crowns Parts

• Replacement parts : documentation of performance required • If significantly change the device they are considered devices

38

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 • Approve once the technical documentation is complete • 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

• If you comply to other legislation it can be included in the one certificate

39

13