Last year, several new guidance documents were published by the Medical Devices Coordination Group (MDCG) – a European Commission body that deals with key issues concerning the medical device and IVD sector – from oversight of Notified Bodies, to new technologies and clinical investigations. Here are a few key highlights:
Classification (MDCG 2021-24)
In October, MDCG published their guide to Medical Device classification for the EU MDR. This guidance document will prove highly valuable as the risk-based classification of devices directly relates to the relevant routes to compliance for manufacturers.
Clinical Investigation (MDCG 2021-28/ -20/ -8/ -6)
Over 2021, the MDCG has released four significant documents relating to the application and review process for clinical investigations. Clinical investigations are one of the most time consuming and resource intensive activities that manufacturers face. In these documents MDCG provides information regarding the clinical investigation application/notification submission process and instructions to assist with clinical investigation identifiers (CIV-ID)
EUDAMED (MDCG 2021-13 & MDCG 2021-1)
The European Union Medical Device database (EUDAMED) has so far gone live with three of six intended modules. MDCG guidance highlighting administrative practices and alternative solutions to employ with regard to EUDAMED during this transition phase is of particular help. In addition, the EUDAMED Q&A is a useful tool to understand the registration rules, etc.
