The Medical Device Coordination Group (MDCG) issued two additional guidance documents in December 2019.
The “Explanatory notes on MDR codes” provide further clarification on the use of designation codes of Notified Bodies (NB) under Regulation (EU) 2017/745. The codes describe for which scope an NB is designated, but also what qualifications the NB staff must have for assessing a device.
For manufacturers, it is important to have a good understanding of the logic behind because they must select an NB who is able to support the corresponding product scope. Also, NBs may require manufacturers to provide the scope of their products when they lodge their application.
The “Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation” provides valuable definitions for a generic device group and category of devices. The guidance furthermore states that NBs must “assess the technical documentation of at least one representative device per generic device group (for Class IIb and Class C) and for each category of devices (for Class IIa and Class B) prior to issuing the certificate.” By reading the document, manufacturers may develop a better understanding of how NBs will review the technical documentation and how the documentation should be organized.
Sources: MDCG guidance documents