Ticking bomb: The implementation of the new EU Regulation for In Vitro Diagnostic Medical Devices (IVDR). HAVE YOUR SAY!
A hard stop for the diagnostic sector in endocrinology is ahead of us if we do not collectively stand up now. Niche applications, rare diseases and rapid responses to health crises are especially threatened.
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 in the attached publication.
The BioMed Alliance, of which the European Society of Endocrinology has been a member of since 2016, has been tasked to provide the European Commission and national competent authorities with critical advice around the implementation of the IVDR. The BioMed Alliance Taskforce on IVD elaborated a questionnaire on the current use of different IVD tests in diagnostic laboratories. The objective of the questionnaire is 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 to make an accurate assessment of the potential impact that the IVDR will have on diagnostic laboratories and their test menu. At the same time, their input will help the BioMed Alliance and its associated medical societies to provide relevant information on this important topic.
The European Society of Endocrinology (ESE) fully supports the questionnaire initiative and therefore we ask our members and their respective endocrine diagnostic laboratories in the EU to fill in a questionnaire on their current use of IVD tests and their preparations for the IVDR (the new EU regulation on in vitro diagnostic medical devices).
You can complete this either online or download and email the form:
Please return the completed questionnaire before September 8th, 2021, to Anne-Claire Cazottes: email@example.com.