Partial Postponement of the Application of the In Vitro Diagnostic Medical Devices Regulation in the European Union

In the January 2022 issue of Clinical Chemistry, we discussed core aspects of the new European Union (EU) regulation on in vitro diagnostic medical devices (European Union 2017/746 regulation, IVDR) (1, 2) and their particular implications for healthcare providers. Following the adoption of the IVDR by the European Parliament in May 2017, the full implementation was originally scheduled for May 27, 2022. Over the 5-year transition period, however, it became apparent that key structural and executive elements required for implementation of the IVDR were still under development (3). For example, the European Database for Medical Devices (EUDAMED) is meant to enable comparison of in-house devices and industrial devices as outlined in Article 5, 5 (d); however, EUDAMED is not yet live. Also, Notified Bodies are meant to certify commercial in vitro diagnostic devices (IVDs); however, there have been structural concerns as the number of accredited Notified Bodies in the EU is still very low. Aggravated by the burden of the COVID-19 pandemic, a gap in both areas raised concerns regarding successful implementation of the IVDR. This scenario led to the recent decision by the European Parliament, which, based on a proposal of the Council of the EU and the European Commission, passed a law that modified the initially proposed transition rules and deferred the application of the provisions concerning in-house devices. This amendment went into effect on January 28, 2022, and specifies in principle a stepwise implementation of the IVDR at different time points (4). It is important to point out that the original IVDR requirements detailed in the IVDR remained otherwise unchanged.