It is now circa ten months since any well-prepared Notified Bodies (NB) wishing to undertake conformity assessment under MDR (EU) 2017/745 and IVDR (EU) 2017/746 were able to submit formal applications.
The date of application of the MDR and IVDR, 27th May 2020, is currently 20 months away. I would like to publicly acknowledge the significant effort and singular focus of the Competent Authorities (CA) to progress applications and meet the forthcoming deadlines.
Given the hiatus before any applications could be formally submitted in November 2017, even the earliest NBs are unlikely to be designated until 2019 – leaving just one year remaining of the original three-year transition period.
For BSI, our contact is with our primary CAs the MHRA (UK) and IGJ (NL). Both have been extremely supportive. BSI submitted its applications on day one for both regulations in both jurisdictions. The response from the MHRA was equally rapid and we were fortunate to be the very first NB to undergo MDR JA in early April this year.
The MDR/IVDR Commission & Competent Authority Joint Audit (JA) of NB is a crucial process. However, there is concern, regarding the availability of resources given the need to handle all applicant NBs in a timely manner.
Recent data published by The European Association for Medical Devices of Notified Bodies (TEAM NB) in July 2018 suggest 11 JAs are currently in the diary (six completed, four scheduled and one with a date to be confirmed). A further five NBs expect to submit this year.
So, what are the implications for market access and, more importantly, patient care?
Here are what I see as the three primary issues:
1. Many NBs (circa 16) are not ready to apply in 2018. Recent data from the European Commission DG SANTE corroborates Team NBs data suggesting 19 applications are likely to be received in 2018 (14 MDR and five IVDR).
2. The rate of JA is likely to slow. This is because, along with the initial JA, a follow up audit is usually required as a key step in the complex designation application process.
3. Based on data from the Nando (New Approach Notified and Designated Organisations) database, there has been a significant decrease in the number of NBs from close to 80 down to 59. This raises questions about whether there is sufficient capacity in the system.
If there is one aspect of the challenge ahead that all stakeholders agree upon, it’s the paramount need to maintain patient access to life saving and enhancing technology. It is also essential to avoid disrupting the supply chain as this is fundamental in the transition to the new regulatory system.
Recent calls from industry to “Stop the Clock” or extend the transition period are understandable. The “grace period” to 2024, whilst useful, is driving many of the manufacturers we speak with to adopt an early renewal of existing MDD certificates as a strategy to guarantee market access. One might argue that, to an extent, this undermines the uptake and positive impact of the Regulation.
The rush to MDD, AIMD and, to a lesser extent, IVDD renewals comes with another risk: the volume of additional conformity assessment activity in 2019. As the EU’s largest NB, BSI anticipates a two-to-three-fold increase in certificate renewal requests in 2019. This is a potential tsunami of regulatory activity.
Manufacturers should open this dialogue with their NB service provider as soon as possible as preparation is all important as we move into 2019.