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, 2021 [*]. 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.
* Note that the paper has not been updated to the one year delay on implementation of the MDR as corrected on April 23, 2020; however for the content relating to the requirements this has no impact.