NB

The new EU In Vitro Diagnostic Medical Devices Regulation (IVDR) was published in May 2017. While the IVDR has a five-year transition period (longer than the three-year transition for the EU Medical Devices Regulation), the procedures to designate Notified Bodies (NBs) under each of these two regulations have started at the same time. NBs are already submitting their applications to Designating Authorities to be ready for the new IVDR. Nevertheless, the new designation process brings up some unique issues for both manufacturers and NBs. When compared to the IVD Directive, the IVD Regulation represents a revolutionary change for both NBs and manufacturers. Under the existing Directive, approximately 10-20% of IVDs have been through the certification process involving NBs; this will increase to more than 90% under the new Regulation. Those who have read the Commission Implementing Regulation EU 2017/2185 (23 November 2017), will have seen how it defined the new scope designation codes [1] representing IVD, and the related scientific/technical competences that NBs must demonstrate to the Designating Authorities. There are now over 80 codes (under the IVDD, there were just 27 NBOG codes), adding a whole new level of complexity. Although the Implementing Regulation was subject to a public consultation and received a number of proposals for amendments , it was, in my view, published without substantial changes (See MedTech Europe’s comments as well as at the amendments proposed by others). Given the wider array of IVDs that will require certification, I believe that the NBs’ goal may be to enlarge the range of product certification that they can offer and to prepare for a significant increase in quantity and quality of work. In order to demonstrate their own expertise to Designating Authorities, NBs will need to determine how many product codes will be covered by their expert teams...

Stefano Dettori

IVD Operative Unit of Notified Body 0373 Italian Health Institute (ISS)