MDR | Guidance documents and updates on clinical investigation and evaluation

Although the date of application of the Medical Devices Regulation (MDR) has been postponed, on 26 May 2021 the Regulation will become fully applicable, following the transition period. As previously shared in April, during 2020 several updates, new guidelines and standards are being issued in order to gradually move forward with successful implementation of the MDR.

Here you can find the latest released documents on this topic:

ISO 14155:2020 – Clinical investigation of medical devices for human subjects — Good clinical practice
MDCG 2020-13 Clinical evaluation assessment report template

All these documents are 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, manufacturers and notified bodies benefit from additional preparation time and the reduction of uncertainty about implementation should ensure a smooth and proper implementation of the MDR.