The medtech sector is going to be waiting for a long time before it has access to updated and new harmonized standards to be cited by manufacturers to demonstrate compliance with the EU’s Medical Device and IVD Regulations.
Missing Cornerstone Of EU MDR and IVDR
EU standards, while not mandatory for the medtech industry, are one of the cornerstones of EU regulation. Manufacturers may cite harmonized standards to argue they have met the Essential Requirements (ERs) of the current Medical Devices Directive. (MDD). But these ERs are being replaced by General Safety and Performance Requirements (GSPR) in the MDR
The European Commission has published a third draft request for standards needed under the MDR and IVDR