Product Conformity Verification

PRODUCT CONFORMITY VERIFICATION

The Product Conformity Verification based on Annex XI of the MDR may be carried out for the medical devices with EU type-examination Certificate for conformance to the type specified. The manufacturer may apply either for the EU Quality Assurance Certificate or for the EU Product Verification Certificate.

EU Quality Assurance Certificate: This certificate is issued for the medical devices that apply for the Product Conformity Verification and that comply to the conformity assessment of production quality assurance specified in the Annex XI part A. This certificate includes the identification of devices or group of devices, the risk classification and for Class IIb, intended purpose also.

EU Product Verification Certificate: This certificate is issued for the medical devices that apply for the Product Conformity Verification and that comply with the conformity assessment of product verification specified in Annex XI part B. Class IIa devices may apply for this certificate without the EU Type -Examination Certificate as an exemption. This certificate includes product identification (name, model, type of device or devices), intended purpose, risk classification, and Basic UDI- DI.

During the surveillance of medical devices with the EU quality assurance certificate, what is the extra step required for the class III device? What are the special exemptions available for a class IIa device that is applying for product verification?