The Medical Device Coordination Group (MDCG) has issued a new Document:
Why does this Guidance Document matter to you?
Many, if not most, IVDD CE marked devices have been granted an IVDR transition period and can continue to be placed onto the market after the IVDR’s date of application: 26 May 2022.
Specifically, the devices eligible for the transition period are those that were self-certified (“other IVDs”) under the IVDD but have been up-classed under the IVDR, and now require Notified Body issued CE marking certificates. These devices are referred to as ‘legacy’ devices.
IVDD devices with Notified Body issued CE marking certificates (e.g., self-test devices) that will be valid after 26 May 2022 are also legacy devices.
Only IVD medical devices that are classified as Class A non-sterile under the IVDR, require immediate compliance on 26 May 2022. Class A non-sterile devices are self-certified by the manufacturer under the IVDR.
However, legacy devices are subject to certain conditions.