2020/09/02 by Blödt, Susanne, Brüggemann, Monika, Freckmann, Guido +17
Medicine · #610 Medical sciences #European In-vitro Diagnostics Regulation #European Union #Europäische Union #Europäische Verordnung über In-vitro-Diagnostika #IVDR #Medicine
paper · doi:10.3205/lab000038
The legal basis for the use of laboratory diagnostics has been fundamentally changed by the European In-vitro Diagnostics Regulation (EU) 2017/746 (“IVDR”). Until this set of regulations comes into full force in May 2022, the entire laboratory diagnostics industry in Germany will only have a short transitional phase to adapt its processes. This affects laboratories that partly or predominantly use in-house tests; here, substantial new requirements must be met. Since the implementation of IVDR is committed to improving patient safety, a prolongation of the transition period by politicians – despite the COVID-19 crisis – is not likely. On the one hand, laboratories need to prepare for increased regulatory supervision of in-house tests. On the other hand, with respect to infringements of competition law, there is a risk that individual diagnostic manufacturers will take action against laboratories using in-house tests, even though a comparable commercial test is available. One of the problematic consequences for patient care can also be that tests covering rare diseases, so called “niche tests”, that were previously commercially available but have low sales, could be withdrawn from the market by manufacturers due to the considerably increasing documentation requirements. Even though the adaptation of national regulations and implementation rules is not yet finished, every medical laboratory is strongly advised to already start dealing with the innovations brought by the IVDR.