Whitepaper

News on the Postponement of the EU Medical Device Regulation, Corrigenda and MDCG guidance

News on the Postponement of the EU Medical Device Regulation, Corrigenda and MDCG guidance contact

Valentyna Starodub

Founder and Chief Executive Officer
News on the Postponement of the EU Medical Device Regulation, Corrigenda and MDCG guidance

This new Starodub white paper, of June 2020,  focusses on the recent legislative developments related to the EU Medical Device Regulation (MDR). The paper addresses the one year postponement of the date of application of the EU MDR due to Covid-19 as also the two MDR corrigenda and the main topics covered by new EU MDR guidance from the Medical Device Coordination Group (MDCG). 

Upon reading this paper you will learn the reasons and consequences, including the benefits, of the EU MDR postponement, understand what has changed in the original published regulation based on the corrigenda, and what the main topics are that have received supportive guidance.