Unprecedented regulatory shift for Economic Operators

February 14, 2020

Maetrics, a leading international life sciences regulatory and compliance consultancy, has launched a whitepaper explaining the new (and changed) responsibilities for Economic Operators required by the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR). The whitepaper looks at the changes in regulations concerning all four Economic Operator entities, highlighting the impact on Importers and Distributors as they face entirely new requirements.

All Manufacturers will have to identify and confirm compliance of their Economic Operators by Date of Application for the EU MDR (26th May 2020). Failure to do so may cause serious ramifications further down their supply chains. The whitepaper aims to draw attention to the fact that three out of four Economic Operators are now legally and severally liable for devices sold on the market. This is an unprecedented change in regulation, with potential serious consequences for those entities involved if compliance is not achieved; in particular legal action and loss of market access.

To read the press release in full, click here.

The full whitepaper is available to download here.