Medical Devices | Guidance documents on clinical investigation and evaluation

This week brings some good news for the medical devices (MD) manufacturers and notified bodies, as 4 different guidance documents on topics related to clinical investigation and evaluation have been published by the MDCG. Along with the guidance on the clinical evaluation for MD Software, released earlier this year, the published guidance related to clinical investigation and evaluation so far includes:

medical devices guidance

Nevertheless, MDCG is working on additional documents to provide with further guidance on diverse topics. As indicated on the “Ongoing Guidance development within MDCG subgroups”, the following are to be expected during this year:

All this guidance is bound to reduce the level of uncertainty regarding the implementation of the MDR. Thanks to the postponement of the implementation date of the MDR and the publication of new guidance by MDCG, manufacturers and notified bodies, who have been working against the clock to deal both with the COVID-19 pandemic and the implementation of MDR, are given a break. This additional time for preparation and the reduction of the uncertainty on the implementation shall ensure a proper and smooth implementation of MDR.