MEDICAL TECHNOLOGY FOR INNOVATIVE DIAGNOSTICS

Note for our European Distributors in regards to the Medical Device Regulation (MDR) requirements

MDR

The Medical Device Regulation (EU) 2017/745 have come into force throughout Europe since May 26, 2021.

The MDR replaces the 93/42/EWG Medical Devices Directive. In addition to the new requirements for manufacturers, also a number of new requirements for distributors (Art. 14 MDR) have come into force, which have to be complied with since May 26, 2021.