In vitro diagnostics regulation
This week sees the end of the in vitro diagnostics directive (IVDD) for new products as the in vitro diagnostics regulation (IVDR) takes its place (26th May 2022). The IVDR is a new world of regulation and represents a significant change in notified body involvement for the In Vitro Diagnostics industry. Under the IVDD approximately 80% of in vitro diagnostic products were able to be placed on the market by a process of self-certification. Only 20% of IVD products (those tests that fell into Annex II list a and b, as well as self-tests) were obliged to undergo notified body assessment. Under IVDR, it is expected that 80-90% of products will now need notified body assessment with only a minority of products (those that fall under CLASS A rules) being legitimate for self-certification.
This change in notified body involvement has been widely publicised and, as highlighted at the recent RAPS Euro convergence, it will bring notified body scrutiny to a significant number of IVD manufacturers who have not previously engaged with a notified body or had their technical files scrutinised. Some less reputable manufacturers may not even have a technical file for their products or an appropriate ISO13485 QMS and, in this sense, the implementation of the IVDR is very welcome as a mechanism to exclude less reputable manufacturers from the market.
What is less welcome, and also highlighted at the RAPS meeting, is that much of the infrastructure to support the full implementation of the IVDR is yet to put in place, for example, the publication of Common Specifications, the European Reference Labs (EURL) for batch release of CLASS D products, EUDAMED. At the moment notified bodies are trying to fill these gaps such as carrying out batch release when possible.
However, the most significant issue is notified body capacity. For IVDD there were 21 notified bodies across the EU (which included the UK at the time). For IVDR there are currently only 7 notified bodies approved. Not only is this a significant reduction in capacity but the proportion of products needing notified body scrutiny has dramatically increased under the IVDR from 20% to 80-90%.
For IVD companies bringing new products to the market the adoption of a new regulation combined with a significant lack of notified bodies represents a major commercial risk. The key question is whether these issues will quickly resolve or whether it is necessary to consider a strategic shift from initial submissions in Europe (where self certification was commercially attractive) to the US where requirements may be more clear. To help answer this question it is useful to look at the current status of the Medical Devices Regulation (MDR) whose implementation in Europe has a 2 year head start on the IVDR.