In all conformity assessment procedures involving a NB, a review of the technical documentation is mandatory.Article 52 of the MDR provides details on the conformity assessment procedures, which are further set out in Annexes IX–XI, depending on the device. The sampling rate applied during audit by your NB is dependent upon the device classification, as detailed in the following list.
• Class III devices: Assessment of the technical documentation for every device
• Class IIb implantable devices (except sutures, staples, dental filings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) and class IIb active devices intended to administer and/or remove a medicinal product: Assessment of the technical documentation for every device
• All other class IIb devices: Assessment of the technical documentation for at least one representative device per generic device group
• Class IIa devices: Assessment of the technical documentation for at least one representative device for each category of devices
• Class I devices which are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments: Assessment of the technical documentation relating only to those specific features of the device, e.g. sterility, measurement or reprocessing
For class I devices, which are not provided sterile, have no measurement function and are not reusable surgical instruments, NBs are not involved in conformity assessment. For such devices, manufacturers shall ‘declare the conformity of their products, by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III’ (Article 52, point 7). NBs are required to take a risk-based approach and must ensure that the technical documentation of all devices has been sampled over the validity period of the granted certificates.
EU Medical Device Regulation 2017/745Article 52 Conformity assessment procedures, point 7:
Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III. If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI. However, the involvement of the notified body in those procedures shall be limited:
(a) in the case of devices placed on the market in sterile condition, to the aspects relating to establishing, securing and maintaining sterile conditions;
(b) in the case of devices with a measuring function, to the aspects relating to the conformity of the devices with the metrological requirements;
(c) in the case of reusable surgical instruments, to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.