Now that the IVDR 2017/746 has taken effect, new guidance for in vitro diagnostic (IVD) manufacturers with assays used in clinical trials has been published. Assays used in clinical trials may range from CE Marked IVDs to trial- or medicinal product-specific assays that aren’t always meant to be sold as IVDs.
The IVDR replaces an earlier Directive, the IVDD, and significantly strengthens the rules for placing medical tests on the EU market. In January 2022, the European Parliament and the Council amended the transitional provisions of the IVDR for IVD devices already on the market. The amendment allows for transition periods for compliance with the new rules based on the risk class of the device.
