IVDR Notified Bodies

Last week, the European Commission designated a fifth notified body (Dekra Netherlands) to certify products under the incoming EU In Vitro Diagnostic Regulation (IVDR). This brings the total number of notified bodies to five.

This is a significant shrinking of certifying capacity from the regime under the existing In Vitro Diagnostic Directive, under which there were 22 designated Notified Bodies. The vastly increased workload for Notified Bodies as a result of the new requirements under the IVDR, will now fall on a smaller number of Notified Bodies able to approve for in vitro diagnostic medical devices.

With the IVDR scheduled to take effect in May 2022 – little more than 300 days from today – we would perhaps hope for more signs of proactivity, by accelerating the rate at which Notified Bodies are designated, or by implementing a transitional period during which manufacturers might be able to certify their products on a conditional or interim basis.

No such proactivity has been observed, despite multiple calls from the pharmaceutical industry and patient groups.

As the Commission prepares to drive the IVDR into a traffic jam of its own making, we hope that a pragmatic approach to implementation and enforcement will protect manufacturers from falling foul of rules with which they have had no chance to comply.

This post was co-authored by Ewan MacAulay