On January 23rd, amid concerns that there is not enough time for manufacturers to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR), the EU Commission announced another proposal to extend the transition period. Previously extended at the end of 2021, this is the second time the Commission will look to provide additional time to the deadlines as it fears many devices are not yet able to meet the regulation. Since the IVDR came into force in 2022, there has been push-back from industry which has led to concerns of a negative effect on the availability of IVDs in the global market. In this latest proposal, the Commission hopes to give manufacturers the added time for compliance while ensuring safety requirements are still being met, noting that a significant amount of IVD manufacturers are small-to-medium sized companies in which availability of resources may play an important role. As outlined in the proposal, the new deadlines would be as follows: Class D diagnostics will be December 2027; Class C will be December 2028, and Class A sterile and Class B tests will be December 2029.
There has been speculation as to whether there will be enough notified body capacity to handle the wave of IVDR applications and reviews, given the current deadlines. Additionally, questions have been raised as to whether continued extensions of the deadlines will cause the Commission to lose face in the eyes of the manufacturers, allowing manufacturers to put compliance on the ‘back burner’. The EU Commission, notified body representatives, and industry experts agree that the extensions will allow for enough time to meet the IVDR deadlines and warn that manufacturers should not rest in their efforts to bring their devices into compliance as soon as possible.
