Why The EU Urgently Needs A One-Year Delay For The IVDR And EU-Wide Exceptions For IVDs
The medtech industry’s call for a one-year delay to the Medical Device Regulation and for EU-wide exceptions from usual medical device rules was granted recently. But not for IVDs, where the situation is described as “grim.”
MedTech Europe’s Oliver Bisazza believes that the EU is going to have to agree to a delay of at least one year in the full application of the IVD Regulation (IVDR).
“It is with enormous regret that we saw the EU lose this opportunity to defer the IVDR,” Bisazza, director of regulations and industrial policy at MedTech Europe, told Medtech Insight during a recent interview
He was referring to the recent amending regulation, which introduced the one-year postponement, until 26 May 2021, of the application date of the IVDR’s sister Medical Device Regulation (MDR).
With only three notified bodies designated against the IVDR so far, potential delays in further designations because of COVID-19 and social distancing could be a real problem for a diagnostics industry that has been preventing from moving towards compliance when there are so many unfinished structures and documents,
“We are more concerned about the IVD infrastructure than ever before,” Bisazza said.
MedTech Europe is also frustrated that the EU chose not to opt for the possibility of pan-European derogations from the need for full conformity assessment procedures for IVDs, as well as for medical devices, within the amending regulation.
This missed opportunity means that it will be much slower to get COVID-19 tests available throughout the EU market, while manufacturers must seek national derogations in every member state where their product is to be marketed.
Bisazza explained why the IVD sector’s current struggles look set to worsen if no action is taken.
Medtech Insight: Why is it so important for the IVD Regulation to be fully applied later than the current 26 May 2022 application?
Oliver Bisazza: The EU’s pace of IVDR implementation progress has been glacial these past three years, while the main focus of the Medical Device Coordination Group (MDCG) has been on the MDR. We believe postponement is still the necessary way to address the IVDR challenges.
If nothing is done, we can expect to relive the kind of anxiety that we have experienced with the MDR over the last three years. The big difference will be that the IVD industry has more daunting challenges because the grace period is shorter – just two years instead of the four originally foreseen for under the MDR. Also, this grace period will only be available for very few products because most products will be transitioning to supervision by notified bodies for first time. Where this is happening, the grace period does not apply and full compliance (including notified body certification) must be achieved by 26 May 2022.
Why do you think that the European Commission did not postpone the IVDR at the same time as the MDR?
Bisazza: It seems the most politically straightforward action for the EU institutions was to act on those deadlines falling in calendar year 2020. If you look at MDR, they only touched 2020 deadlines. I imagine the IVDR did not fall into that short-term priority because its date of application is in 2022. However, this is just our educated guess. The reality is the commission has not formally replied to our request to pause the IVDR transition.
If IVDR implementation has been glacial so far, are you optimistic that progress will now start to be made in terms of the IVD sector’s readiness? Or is the current pandemic situation going to cause further problems?
Bisazza: The current situation is grim and COVID 19-has further exacerbated that, meaning the IVDR storm continues to brew.
Indeed, COVID-19 has had an enormous impact on many manufacturers’ ability to transition to the IVDR according to their original plans and timelines
Some companies who were as ready as they could have been at this stage in terms of IVDR compliance have had plans their heavily impacted. This might have been, for example, because audits cannot go ahead with their notified body or because they were expecting their notified body to be designated under the IVDR this year and the timeframes are no longer clear.
Many IVD manufacturers now have clinical studies on pause too, because of COVID-19, and some estimates suggest it could be nine months before they can restart them. This obviously delays when they can file for conformity assessment.
We also have fears that the MDCG will not be able to focus on the IVDR until mid-2021, once the full application of the MDR has gone ahead.
Why is the EU decision not to bring in Europe-wide derogations for IVDs such a problem?
Bisazza: The need for different types of tests for COVID-19 – whether PCR/antigen or serology/antibody – is well understood, as is the World Health Organization’s advice that all countries rapidly ramp up testing for both current and past infection so doctors know what they are treating and restrictions can gradually be eased.
Globally, several countries, including Australia, Canada and the US, have all put in place emergency authorization procedures for new COVID-19 tests while they are still going through regulatory approval. But the EU, as a single market, has not.
In the EU, we are stuck with derogation regime under the IVD Directive, which means that manufacturers must seek derogations country by country. This involves addressing different information requirements, languages and timelines.
The results are delays and inequities in access. Manufacturers would be more inclined to try and get derogations to sell their tests in larger, more financially viable markets. But this would disadvantage smaller member states. This tendency has already been witnessed with previous outbreaks, such as H1N1 (swine flu).
Might the EU decision-makers have considered it unnecessary to have an EU-wide derogation mechanism for COVID-19 tests as they are “general IVDs” under the IVD Directive, with a relatively simple route to market and no notified body involvement?
Bisazza: You need derogations in a crisis because these tests are required very quickly, while the manufacturer is taking the test through the strict requirements of the IVD Directive. Before a derogation is given, the national competent authority will still confirm which criteria need to be met.
Even without notified body involvement, IVD manufacturers still need to demonstrate they meet the IVD Directive’s essential requirements, including clinical sensitivity requirements. They need to access samples of the virus to do validation testing, and this means the full CE marking process can take six months or more if done properly. Moreover, in the case of COVID-19 there have been challenges accessing reference sample to do this validation testing.
How common is it for substandard tests to reach the EU market and what is being done about this?
Bisazza: One troubling recent trend is the emergence of certain COVID-19 tests that bear the CE marking but that were launched so quickly that there are legitimate questions over how thoroughly full compliance with the IVD Directive was checked.
Indeed, there have been reports of some member states procuring inaccurate COVID-19 tests which, thankfully, are being picked up by the national market surveillance authorities. This underlines the crucial role that member states have in proper enforcement of the regulatory system and active surveillance.