European Commission Proposes Another Delay in IVDR Compliance

In the face of inveterate manufacturer foot-dragging and a dearth of certified review bodies, the European Commission (EC) is once again proposing to extend the deadline for companies to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR).

Manufacturers of high-risk Class D IVDs would have until Dec. 31, 2027, to come into compliance. Class C devices would need to comply by Dec. 31 2028; Class A and B devices have until or Dec. 31, 2029, according to the EC proposal.

This is the second time the compliance deadline has been pushed back. Part of the European Union’s Medical Device Regulation, the IVDR was originally slated to go into effect May 26, 2024. The regulation requires non-governmental Notified Bodies to either recertify or remove devices from the marketplace.

To read the whole story, click here to subscribe.

Related Topics