The European Medical Device Regulation (MDR 2017/745) took effect on May 26, 2021. Manufacturers holding valid Medical Devices Directive...

How do we break this to you gently? OK we can't. The blunt answer is no. Starting May 26, 2021 there are some aspects of the European...

Medical device regulations have been on the books for decades, long before software was widely used in medical devices, and certainly...

A Single Registration Number is assigned to all medical device legal Manufacturers, Authorized Representatives, System/Procedure Pack...

Article 13 of the European Medical Device Regulation and In Vitro Diagnostic Regulation (IVDR) requires you to appoint an EU importer....

By now you certainly know that Article 13 of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require you...