The new EU In Vitro Diagnostic Regulation (IVDR) that takes effect on May 26, 2022 requires labs, what are called “authorized representatives,” and other stakeholders to carry out major operational tasks such as revising documentation about their products, recruiting new staff, and updating internal procedures. The other major bottleneck is the limited number and capacity of what are called Notified Bodies (NBs) responsible for certifying all diagnostics that need to be assessed for the first time before the IVDR can go into effect. The IVDR will bring around 80 percent of in vitro diagnostic medical devices under the control of NBs, as opposed to just the 8 percent covered by current regulation.
While leaving the substantive requirements intact, the EU’s new implementation plan provides for longer transition periods, i.e., grace periods in which current certification will remain acceptable, for different types of devices, depending on the risks they pose:
- Certificates for lower-risk Class B and sterile Class A devices will remain valid until May 26, 2027;
- Certificates for medium-risk Class C devices, which covers most molecular tests, including genetic tests, companion diagnostics, infectious disease tests, and assays for stratifying cancer patients, will remain valid until May 26, 2026; and
- Certificates for higher risk Class D devices, such as HIV or hepatitis tests, will remain valid until May 26, 2025
The new compliance deadline for in-house devices is May 26, 2024. Exception: The provision requiring labs to justify their use of an in-house device instead of a commercial, compliant test, has been pushed back until May 26, 2028.