There are only 3 weeks left until the implementation of the new European Regulation on In Vitro Diagnostic Medical Devices, which aims to create a safer, more transparent, reliable and predictable environment for these products.
For us as manufacturers, this new regulation is good news as, for the first time, the requirements for all diagnostic solutions in a laboratory will have to comply with the same regulation, meeting rigorous quality and safety standards.
At the level of regulators, notified bodies and reference laboratories, stricter controls are established, both for their designation and for the evaluation of products and their access to the market, as well as reinforcements in the surveillance system.
Although the implementation date of the new regulation is 26 May 2022, a few months ago Regulation 2022/112 of 25 January was published, amending Regulation (EU) 2017/746, providing an additional period for certifying products: higher risk products will see their deadline extended until 2025; high risk products until 2026; and low risk products until 2027.
However, this extension may not be enough, given that 53% of manufacturers still do not have a notified body, according to sources from the Spanish Federation of Healthcare Technology Companies (Fenin). Therefore, taking into account that IVD products requiring external certification have increased by 70% (from 15% to 85%), it seems necessary to increase the capacity of these bodies to cover this demand.
Given the current situation, we at BDR consider ourselves fortunate. Over the last two years we have been preparing, together with our Notified Body (BSI), how to comply with the new Regulation. Our management system has already been audited, with good results, and the technical files of our products have been submitted. We expect to be certified under CE-IVDR during this month of May.