First published in our Biotech Review of the year – issue 9.

Transitional provisions for devices certified under the old Directives remain in place, but from now on every new medical device placed on the market in the European Union will need to be CE marked under the EU MDR.

The EU MDR is only half the story though. The second half of the new EU medical devices framework is the In Vitro Diagnostic Medical Device Regulation 2017/746, or EU IVDR, which replaces the old In Vitro Diagnostic Medical Device Directive. Despite preparations for the transition to the EU IVDR being disrupted by COVID-19 just as much as preparations for the transition to the EU MDR, the date of application for the EU IVDR is not currently being delayed and will take effect on 26 May 2022 – although the European Commission will extend transitional periods to ensure availability of existing products and relieve some of the burden on manufacturers of in vitro diagnostic medical devices (IVDs).

Based on our experiences with the EU MDR so far, this article takes a look at what we can expect from the year ahead as the EU IVDR comes into effect.

Up-classification

As was the case with the EU MDR, the EU IVDR will increase the regulatory burden on many medical devices in a major way. This is because a large number of IVDs which were previously considered low risk under the old In Vitro Diagnostic Medical Device Directive are being moved into a higher risk class under the EU IVDR – so-called “up-classification”. That means that IVDs which could formerly be self-certified by the manufacturer will need to undergo conformity assessment by a notified body for the first time.

It is estimated that up-classification will increase the workload of notified bodies under the EU IVDR by 700% over the old Directive.

Limited notified body capacity

At the same time as the amount of work which notified bodies are expected to do will increase under the EU IVDR, the number of notified bodies available to actually do that work will be far lower than it was under the old Directive, at least to begin with. 22 notified bodies were designated to conduct conformity assessments under the old Directive. At present, only 6 notified bodies have been designated to conduct conformity assessments under the EU IVDR. This is an issue that the European Commission’s Medical Device Coordination Group has been aware of for some time and again noted in its recently updated Joint Implementation and Preparedness Plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

According to the European Commission, 11 further notified bodies are currently undergoing the process for designation under the EU IVDR. However, the rate of progress has been glacial. This is partly due to COVID-19, which has disrupted the performance of on-site audits for prospective notified bodies.

However, there was a very similar lack of progress in designating notified bodies for the EU MDR prior to its original date of application in May 2020. In fact, as of November 2019, there were only 7 notified bodies designated to perform conformity assessments under the EU MDR, compared to 58 designated under the old Directives. Based on that history of slow progress, it is probably more the case that COVID-19 has contributed to the delays in designating notified bodies under the EU IVDR than COVID-19 causing those delays. There is no reason to expect that progress in designating EU IVDR notified bodies will particularly accelerate as the severity of the pandemic in Europe winds down.

Extension to transitional periods

The lack of progress in designating EU IVDR notified bodies has caused some major consternation in the European life sciences industry. MedTech Europe conducted a survey of its members to assess the impact of the lack of EU IVDR notified body capacity on the European IVD market. Results reported in September 2021 showed that 53% of manufacturers still did not have a notified body for the EU IVDR and that more than 22% of IVDs currently on the market could be lost due to a lack of capacity to perform the necessary conformity assessments.

Even the European Federation of Pharmaceutical Industries and Associations (EFPIA), together with the European Cancer Patient Coalition and Diaceutics, felt the need to weigh in and express concern at the lack of progress in designating notified bodies in an open letter published in May 2021. As the European trade body for medicinal products, EFPIA does not usually concern itself with medical devices let alone IVDs, which gives some indication as to how severe it considered the situation to be. The open letter called for an immediate one-year postponement to the date of application for the EU IVDR (akin to the postponement of the EU MDR date of application) and a phased introduction of the EU IVDR, starting with the highest risk classifications of devices.

We are unaware of any plans to postpone the date of application of the EU IVDR. However, the European Commission proposed in October 2021 to amend the EU IVDR in order to extend the transitional provisions for IVDs which are already on the market under the old Directive, and its proposals were adopted and brought into law on 20 December 2021. The extensions are structured in such a way that the devices in the highest risk classes will lose access to the transitional provisions before the lowest risk classes. Essentially this creates the sort of phased implementation which EFPIA was asking for in its open letter, which should take some of the initial burden off of the notified bodies as the need to perform conformity assessments for existing low risk devices will be deferred until after the high risk devices have been dealt with. We expect a lot of IVD manufacturers will seek to refresh their existing certificates before the EU IVDR date of application in May 2022 to ensure they can benefit from the extended transitional provisions for as long as possible.

It is worth noting that the transitional period extension is not a magic fix. As of the date of application in May 2022, manufacturers of new IVDs will still need to seek conformity assessment under the EU IVDR, and will still have to battle with a lack of notified body capacity. Furthermore, devices on the market under the EU IVDR transitional provisions will still need to comply with all the other obligations which the EU IVDR contains, even if the conformity assessment was conducted under the old legislation. May 2022 will still herald a significant increase in regulatory burden for IVDs.

[NB: Since writing this article, two trade bodies for the medical technology industry expressed their concern about a potential “collapse” of patient care.]

Postscript on the AI Regulation proposal: the stalking horse

The extended EU IVDR transition periods should certainly alleviate some of the pressure on notified body capacity for in vitro diagnostic medical devices. Looking beyond 2022 though, there may be another source of additional pressure on notified bodies coming down the pipeline: the EU Artificial Intelligence Regulation (AI Regulation).

If and when it eventually comes into force, the AI Regulation will introduce a new conformity assessment and CE marking process for “high risk” AI, which is substantially the same in structure as the conformity assessment process for medical devices and in vitro diagnostic medical devices under the EU MDR and EU IVDR. The definition of “high risk AI” devices under the AI Regulation specifically includes AI systems which are incorporated into devices regulated under the EU IVDR or EU MDR. By way of illustration, an in vitro diagnostic medical device which relies on an AI system to analyse a sample of genetic material from an individual and determine the risk of that individual suffering from a particular cancer at some stage in their life would need to undergo conformity assessment against the standards of both the AI Regulation and the EU IVDR.

Under the proposed AI Regulation, conformity assessment of AI components of in vitro diagnostic medical devices will be conducted as part of the same process as conformity assessment against the requirements of the EU IVDR, avoiding the need for two separate bodies to conduct two separate conformity assessments on the same device. In principle, this is sensible as it should prevent duplication of work. However, it will increase the work burden on EU IVDR notified bodies at a time when they are already struggling with a lack of capacity. Additionally, as Team NB pointed out in a recent position paper, recruiting AI experts to conduct AI Regulation conformity assessments will be a major challenge for notified bodies, given the relative dearth of computer science expertise in the European Union right now. The European Union may manage to scrape together enough notified body capacity to weather the first few months and years of the EU IVDR after May 2022, but the AI Regulation could be a further bitter pill to swallow.