On 26 May 2022 the new EU Regulation on in vitro diagnostic medical devices (the IVDR) will come into full effect, replacing the old legislation (the IVDD). This will have substantial consequences for diagnostic laboratories:
- Under the IVDR, they will be responsible for generating sufficient clinical evidence and technical documentation for their in-house devices (IH-IVDs or lab developed tests/LDTs);
- If equivalent CE marked IVDs (CE-IVDs) are available from manufacturers, these will have to be used instead; use of IH-IVDs is not permitted anymore in this situation;
- CE-IVD tests sold after 26 May 2022 have to be CE marked under the IVDR with the exception of 1) IVDD-certified CE-IVDs placed on the market before the date of application (e.g. at a distributor) can still be sold until 2025 and 2) CE-IVDs with a valid IVDD certificate issued by a notified body (this only concerns certain high-risk tests) can be sold until 2024;
- Laboratories that use IH-IVDs need to work under an appropriate Quality Management System (ISO 15189 or applicable national provisions);
- A more detailed description of the consequences of the IVDR for diagnostic laboratories can be found here.
This means that the transition to the IVDR needs to be prepared carefully by diagnostic laboratories, including making an assay inventory. The BioMed Alliance aims to support this preparation in order to ensure continuity in laboratory diagnostics beyong May 2022. With this questionnaire, we aim to gain insight into the current situation for medical laboratories, in particular the degree of (un)preparedness of medical laboratories for the IVDR implementation, and the impact that the IVDR will have on their test menu. Your input will enable us to supply you with better information and to better represent you in the process of the EU implementation of the IVDR.Note that your contribution will be treated as strictly confidential; laboratory- specific information will never be shared with third parties or made public.
In case you have any questions, please contact Dr. Bart Lubbers: email@example.com or Dr. Isabel Dombrink: Isabel.Dombrink@uksh.de.
Thank you in advance for your contribution!