[Translate to Englisch:] In-vitro-diagnostics

Amendment of the transitional periods of the European In-Vitro-Diagnostics Regulation (IVDR)

The AWMF (Association of the Scientific Medical Societies in ) has informed that on December 16, 2021, the European Parliament decided on a differentiated postponement of the application of individual components of the IVDR. This partly also concerns in vitro diagnostics from own production. 

In recent months, various parties have called for a postponement of the implementation of the European Regulation on In Vitro Diagnostics (IVDR). The reason for this demand is, in particular, the fact that the European Commission has not yet implemented essential procedural elements or has not done so on time; the central medical devices and diagnostics register EUDAMED, and the insufficient number and capacity of the Notified Bodies accredited to date are particularly worthy of mention here. 

This postponement concerns only partial aspects of the IVDR. In particular, Article 5 (5) d) is affected, according to which in-house diagnostic devices may only be put into service as long as no similar product is available on the market that meets the requirements of the relevant patient groups (so-called industry privilege). This is mainly due to the fact that EUDAMED has not yet been implemented as a basis for market sounding by laboratories. According to the current decision of the European Parliament, letter d) is not to be applied until May 2028. 

For subparagraphs (b) and (c) and (e) through (i) of Article 5 (5), i.e., management system requirements, manufacturing justification statement, public manufacturing statement, detailed manufacturing documentation, and evaluation of user experience, the application deferral is until May 2024. 

However, as provided for in the IVDR adopted by the European Parliament in 2017, when the five-year transition period ends in May 2022, in vitro diagnostic devices manufactured in-house must still comply with the general performance and safety requirements set out in Annex I of the IVDR; the diagnostic devices must not be supplied to other entities or manufactured on an industrial scale, according to Article 5(a). 

In recent months, the AWMF Ad Hoc Commission In-vitro Diagnostics has developed several documents to serve as guidance for diagnostic laboratories commissioning diagnostics from in-house production. They are available on the AWMF website. 

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