MedTech Europe calls for improved transition time measures for Class D IVDs

Posted on 01.02.2024

In its position paper, which was published in December 2023 and can be found here, MedTech Europe aims at alerting decision-makers about several issues related to Class D devices and their transition under the IVD Regulation. Recommendations are also made to Notified Bodies and to EU Reference Laboratories.

MedTech Europe supports any measures to keep IVDs available to the patients who need them. Regarding the European Commission proposal to extend the transition timeline for IVDs, including Class D: any additional time given must be used by the European Commission and all actors to action the efficiency-improvements needed for all manufacturers to transition their devices to the IVD Regulation and bring in new innovations.

Finally, the paper provides a scientific rationale for re-classification of tests for exposure to or detection of SARS-CoV-2 tests. COVID-19 is no longer considered a pandemic or a generally life-threatening condition.