Bonjour Pascale,
First, there is no such thing as Laboratory Developed Test (LDT) under the EU IVDR 2017/746 so really for Europe this nomenclature should not be used. Indeed you are correct Health Institutions can use their own tests which they develop, create, and use for specific purposes. The idea of Company A offering mass-produced components A, B, C, D, E, F, and G to hospitals, clinics, or institutions where they say, "By the way, if you use the combination of E-F-D-C-B-A-G ... you know it might tell you about this disease marker ..." This is not the intention of the regulation nor how it should be done in Europe - they have made this quite clear in the regulation.
In addition, the concept of Research Use Only (RUO) products is not under the scope of the EU IVDR either, please read Article 1, point 3(a) and Article 2 point 45. It clearly states research use only products are not in scope of the regulation, quite clear research use products are not CE Marked. If products are used for research, that is exactly what they are intended:
research. Meaning they are not to be used for reporting patient results and making clinical decisions based on those results.
To answer your question there are two pathways under the EU IVDR: 1) the product is CE Marked according to Article 47 and 48 (and all the other requirements of the regulation) or 2) the product is used in a Clinical Performance Study (investigational device) which complies with all the requirements under Article 57 (and all the other requirements of the regulation for devices under performance studies). Well there is the third for laboratories, they must follow the requirements under Article 5 point 5 which for me is quite clear including: 'This paragraph shall not apply to devices that are manufactured on an industrial scale.'
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 07-Jul-2021 07:48
From: PASCALE BLANGARIN
Subject: Laboratory Developed Tests and European regulation 2017/746 (IVDR)
Hello everyone,
My question : according to the IVDR, LDT was devices manufactured and used only within health institutions established in the Union, all the process must be in the same entity, in this case how to consider research-only devices, developed, produced and sold by an external manufacturer and used by laboratories for delivering patient results? What will the laboratory have to do to continue using such devices under the IVDR?
Thanks a lot for your answer
Pascale
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PASCALE
France
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