New MDCG guidance documents under the MDR and IVDR

European Authorized Representation for Manufacturers of Medical Devices mdi Europa - EU flags in front of EU parliamentEuropean Authorized Representation for Manufacturers of Medical Devices mdi Europa - EU flags in front of EU parliament

There certainly is a backlog in guidance especially related to the IVDR. In May, however, the Medical Device Coordination Group (MDCG) has issued a number of documents that may help manufacturers and other economic operators in the IVDR implementation:

MDCG 2022-7 is a Q&A document around the topic of Unique Device Identification (UDI). Questions are structured in different categories, i.e. UDI-DI, Basic UDI-DI, UDI Labelling, Systems and Procedure Packs, Retail and Promotion, Kits and Eudamed. We have received specific questions regarding UDI in the past months. Please review the document to see if unaddressed issues are answered with the guidance.

MDCG 2022-8 provides information on which IVDR requirements are applicable for legacy and old devices, i.e. those products that have been or will continue to be placed on the market under the IVDD. The guidance is based on MDCG 2021-25, which has been set up for medical devices. It provides valuable information including an annex table as to how economic operators should understand the transitional provisions and what specific provisions must be implemented.

MDCG 2022-9 includes advice and a template for IVDR manufacturers to set up a summary of safety and performance. This is a requirement for class C and D devices.

Lastly, MDCG 2022-10 is also intended for manufacturers of IVD medical devices under the IVDR. It is a Q&A document that addresses specific issues related to assays used in clinical trials. The latter may range from CE-marked IVDs to trial- or drug-specific assays that are not always meant to be developed as IVDs – regulatory questions are not always clearly addressed for these cases.

Should you be interested in receiving one or several of the documents, please let us know and we will be happy to provide.

Source: MDCG

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