News on the Postponement of the EU Medical Device Regulation, Corrigenda and MDCG guidance (June 2020)

This white paper focusses on the requirements for importers and distributors under the new European Medical Device Regulation. This new regulation, the EU MDR (2017/745), was published in 2017 and will be effective as of May 26th, 2020. On this date new legal requirements will apply to many stakeholders active in the medical device business. The most affected are manufacturers that market medical device products under their own name, but new are also explicit requirements for authorised representatives, importers and distributors. In the EU MDR these four stakeholders (manufacturer, authorised representatives, importers, distributors) are referred to as Economic Operators and three of them have now been named to be also legally liable for defective devices when not complying to the general obligations of this new regulation.

Are you and importer or distributors? If so, you are wise to read, understand and implement the relevant requirements of the new EU MDR. This paper summarises these new requirements.