May 26^th, 2022, served as an important milestone for the transition to the new IVDR (In Vitro Diagnostic Regulation) standards in the EU. The date marked the deadline for manufacturers to apply to a Notified Body for a conformity assessment of their IVD devices, to update their technical documentation to meet new requirements. This regulation, by setting high standards of quality and safety, aims to guarantee the proper functioning of the European market and to ensure a high level of health protection for patients and users.

Major changes are introduced by this new regulation such as a new risk classification system, the need to demonstrate the Clinical Evidence of devices, the establishment of more stringent Post Market Surveillance and Vigilance requirements, new responsibilities for authorized representatives, importers and distributors and a new unique database to ensure more transparency. But the strengthened role of the notified bodies is probably the most important revolution.

Notified Bodies: a particularly key player in the CE marking process

IVDR replaces the older IVDD (In Vitro Diagnostics Directive) regulation to better address the needs of today’s emerging technologies. The biggest difference between IVDD and IVDR will be the massive increase in products that require the approval of a Notified Body (EU official list of designated NB). Under the old IVD Directive only 8% of the commercialized IVD devices required a certification from a Notified Body versus more than 80% under the IVDR.

New timelines for Technical Documentation review by Notified Bodies will range from 6 to 12 months, causing product launch plans to adjust accordingly. 

With this increase, the adequacy of the number of Notified Bodies is questioned by the entire industry. According to a survey conducted by Climedo, a health IT player, in April 2022: 43% of surveyed IVD companies declared not yet having a Notified Body. MedTech Europe, the European trade association for the medical technology industry, supports the goals of IVDR but advocates urgently designating and building considerably more Notified Bodies capacities to support certification of all IVDs.

A transition phase to help industry comply with the new rules

There are more than 500,000 types of medical devices and IVDs currently on the EU market. During the transitional period, products with a valid IVDD certificate can remain on the market if they still comply with the obligations under previous legislation, have not undergone significant changes to their design and will use the new regulatory requirements for post-market surveillance and vigilance.

The regulation amends and extends the transitional provisions of existing devices compliant with IVDD according to their IVDR device classification. The products which present lower patient and public health risks (Class A sterile and Class B) have more time to be compliant, their transition period will last until May 2027.

While the roadmap is now very clear for existing products, the industry considers it is essential that regulators address the critical issues of bringing innovative or new solutions to the market and setting up the necessary infrastructure to obtain the new certification. In vitro diagnostic players call for measures to guarantee ground-breaking or incremental innovations continue to be CE-marked under the new regulation. Ensuring both innovative and updated IVD devices can be certified under the IVDR and reach patients and healthcare systems is a crucial challenge according to MedTech Europe.

As more products gain IVDR approval, industry members across the EU will be able to increase their harmonization and strengthen their commitment to research and collaboration. Notified Bodies will focus on clinical evaluation and promote increased transparency through the wider supply chain. These changes also create a need for education and training on how to navigate the intricacies of these new requirements.

Additionally, IVDR is not solely a European topic. For example, changes to Instructions For Use (IFU) might trigger re-submissions to health authorities in countries outside the EU where the product is registered. Although compliance with IVDR is an important investment for manufacturers, we must keep in mind that it only serves one purpose: patient safety across the world.

For more information for how bioMérieux is addressing these regulatory changes, learn more at our Product Quality and Safety page for IVDR. 

Opinion expressed in this article are not necessarily those of bioMérieux