
As Notified Bodies (NBs) in the European Union (EU) begin to roll out Article 16(4) of the European Medical Devices Regulation 2017/745 (MDR) and the European In-vitro Diagnostic Medical Device Regulation 2017/746 (IVDR) certification schemes, we at Emergo by UL share our insights on the requirements set out in Article 16 and their applicability to importers, distributors and other natural or ..