IVDR and MDR – finding a way through

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.

Gauging regulatory risk against the MDR

The latest transition timeline from the European Commission’s website shows the two year head start that MDR transition has had over IVDR transition. This head start has allowed 29 notified bodies to be approved for MDR assessments which is over 4 times the number of notified bodies currently listed as being able to assess to the IVDR (7 are currently listed on https://ec.europa.eu/).

Despite this head start and the additional notified body “muscle” the MDR transition process remains a significant commercial risk for companies seeking to market their medical devices in Europe. The MedTech Strategist Innovation Summit in Dublin provides an excellent forum to gauge views from the industry as it brings together start ups, venture capitalists, corporates and expert service providers. The overriding view at the conference was that the MDR was admirable in its intentions, but its implementation was a mess. During one session, the stark data from notified body associations was highlighted:

• To hit the 26 May 2024 deadline, over 25,000 MDR certificates will need to be issued for legacy products alone.
• Over the last 5 years, notified bodies have been able to issue 1000 certificates
• As a combined entity, notified bodies believe they have capacity to issue ~6,300 certificates per year.

These figures suggest that more than 10,000 legacy medical devices will need to be removed from use in May 2024. This is a huge commercial risk for MedTech SME’s with 10% considered to be at risk of disappearing if transition dates are not pushed back.

The net effect is that innovative, venture-backed MedTech companies are now choosing to focus initial approvals on the US with an overriding view that, compared to Europe, the US offers a large market, a single reimbursement code and criticality, clear guidance from the FDA on what is needed clinically. With notified bodies taking time to align and adapt on how they interpret the MDR, it was felt that regulatory uncertainty, and hence commercial risk, was being managed by aligning to the FDA and that it would likely take another 2 to 5 years for Europe to return to business as usual.

This situation need to be considered carefully by both medical device and in vitro diagnostics companies planning to bring novel technologies to market. When building your Design and Development Plans, it is sensible to ensure that you plan to meet both ISO 13485:2016 and FDA 820.30 Design Control requirements. This is an integral part to the design and development process we use at Team Consulting and it gives our clients maximum flexibility in managing the regulatory strategy and commercial risk.

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