Regulations (EU) 2017/745 and 2017/746 on medical devices or in vitro diagnostic medical devices respectively (MDR and IVDR) form a dynamic regulatory environment. Many guidance documents and related articles have been published throughout the past years and it appears challenging to not lose track of recent changes.
In this context, MDCG 2020-3 was published mainly for manufacturers of MDD legacy medical devices to provide clarity on significant versus non-significant changes. Only non-significant changes may be implemented under the scope of an MDD certificate. The Medical Device Coordination Group has now updated the document considering the most recent extension of the transition period or medical devices until 2027/ 2028.