EU IVDR: Risk Of Noncompliance Is A Real Threat Under Current Deadline Pressures
Cries for the EU to pay more attention to IVDs are growing louder by the day. It is feared the EU IVD sector is heading for a crisis and safe products will have to be pulled from the market.
The European Commission has become too far behind in producing guidance and the structures needed to support the in vitro diagnostics sector in timely compliance with the new IVD Regulation.
That is what attendees heard on the first day of the RAPS Convergence 2020 online conference during an opening panel session on the EU Medical Device and IVD Regulations (MDR and IVDR) on 14 September.
The current lack of infrastructure to comply with the IVDR means that it is impossible not only for manufacturers, but also for notified bodies to plan adequately.
This is impeding their progress at a time when many other factors are competing for time and resources, resulting in IVDs being squeezed out of the picture. There is a growing risk of a significant level of noncompliance when the IVDR fully applies on 26 May 2022.
The one-year delay in the full application date of the MDR and COVID-19 related measures are making an already difficult situation even more challenging for the industry, attendees heard.
Dilemma For Notified Bodies
Notified bodies are finding it particularly tough in preparing to have the right skillsets for the demand that is coming from IVD manufacturers who are seeking audits under the IVDR.
Erica Conway, global head of IVDs at BSI UK notified body, reminded the meeting that the gap between the current IVD Directive and the IVD Regulation is greater than that between the Medical Devices Directive (MDD) and the MDR. “The effort and knowledge gap is huge,” she told the meeting.
This is mainly because some 80% of IVDs are being reclassified from the general IVDD risk class, where notified body involvement was not necessary, into a risk class, B, C or D, where notified body involvement is required.
She spoke of how BSI is aiming to have the necessary auditing staff available in time but did not know how many products in the different IVD sectors are on the market, and what the level of the demand will be.
“We are recruiting,” she said, “and hoping we will have the right people.”
Conway referred to the various structures that are still missing for IVDs, particularly the European reference laboratories and expert panels, which will be needed for class D IVDs and which will not be in place before the beginning of next year. This will mean a delay for work on those products which are most labor intensive.
The sector is also in urgent need of more notified bodies designated against the IVDR. At present there are just four compared with 22 under the IVD Directive, where only some 10% of products need notified body involvement.
The slow progress in designating IVD notified bodies against the IVDR is particularly worrying given that, as Philippe Auclair, senior director of regulatory strategy EMEA at Abbott Laboratories said, there is going to be a 700% increase in the number of IVDs that will need a notified body certificate. “Given how few notified bodies have been accredited so far, we may face a bottleneck,” he added.
Conway, meanwhile, also highlighted how critical it is to have guidance as soon as possible to support compliance with the IVDR. But she noted that COVID has diverted, a lot of the efforts of manufacturers, the commission and member states, resulting in in “a poor support situation for the IVDR.”
Armin Ritzhaupt, scientific advisor at the European Medicines Agency, noted with respect to companion diagnostics (which fall mainly into Class C – Ed), that guidance coming out just a few months before the IVDR fully applies is of little or no help. This is because of the amount of time it takes companies and the notified bodies to adapt to that guidance.
Plan B Needed for IVDR
Oliver Bisazza, director of regulations and industrial policy at MedTech Europe, spoke of the growing lobby for the IVDR to be delayed, just as the MDR has been.
Industry, authorized representatives, physicians and hospitals are all sending papers to the EU institutions raising the timelines issue, and many are raising the possibility of a postponement, he said.
Postponement of the IVDR deadline may not be the only way out of the current challenges, he acknowledged, but there needs to be an open discussion about how a successful transition is possible.