Brice Ezzouaouy, senior product manager at Beckman Coulter Life Sciences, looks at the journey of the 2017 IVD Regulation and how it affects different aspects of the industry.
The 2017 IVD Regulation (IVDR) undoubtedly aims to raise the safety and quality standards of in vitro diagnostics. However, it introduces various complications not only for manufacturers, but also for laboratories conducting studies with homebrew assays or Laboratory Developed Tests (LDTs). While we were in the latter half of the five-year transition period, many companies and labs had not yet managed to commit to IVDR compliance. Although the May 2022 deadline has been extended, the European Union did not compromise on the strenuous certification and documentation tasks. The more companies and laboratories utilise the transition period to prepare for IVDR compliance, the less hindrance there will be in medical device supply in Europe when the regulations are in full effect.
With that in mind, it helps to take an overview of the IVDR marathon and discuss its implications on different components of the IVD sector.