With the recent designation of PCBC[1] and ECM[2] as Notified Bodies under the EU MDR[3], the European Union continues to make progress on expanding its conformity assessment capacity for medical devices. These most recent designations bring the total number of EU MDR Notified Bodies to 34.

Capacity under the EU MDR is still some way behind where it needs to be. Under the previous regulatory framework, a manufacturer of a medical device had access to more than 50 different Notified Bodies which could conduct a conformity assessment, and the proportion of medical devices requiring conformity assessment was also much lower.

However, at least the trickle of new designations appears to be consistent and so capacity is clearly growing.

Unfortunately we cannot say the same for Notified Body capacity under the IVDR[4]. There are still only seven Notified Bodies designated under the IVDR, and the last new designation was five months ago. We might see another before the end of the year, but IVDR designations have been so irregular that it is impossible to tell.

Is the European Commission about to be forced into a volte-face on EU MDR transition periods?

The urgent need for more Notified Body capacity is something that we at On The Pulse have written about at length and in detail for a number of years now, and we would urge you to look back through our publication history to understand why Notified Body capacity matters.

However, for present purposes the problem is succinctly encapsulated in the points made by Dario Pirovano of MedTech Europe at the recent ABHI Regulatory Conference in London. The EU MDR transition periods are only three years long, expiring on 26 May 2024. In that time, all existing medical devices which have been certified over the past 30 years under the previous regulatory framework must undergo a new conformity assessment by a Notified Body under the EU MDR. Any existing medical devices which do not successfully complete conformity assessment before those three years expire will have to come off the market, or their manufacturers will have to beg EU national competent authorities for special permission to keep them on the market on public health grounds.

As a number of speakers at that conference pointed out, that is a large amount of work to complete in a short period of time. That is also only the work which is required to keep existing products on the market, never mind the work which is needed to conduct conformity assessments on new medical devices!

This problem is compounded (but ultimately not caused) by the slow rate at which new Notified Body capacity is being added.

We have written previously about calls from senior figures in European medtech, pharma and patient organisations for the European Commission to dramatically extend the EU MDR and IVDR transitional periods, to give more time to designate new Notified Bodies and to complete the conformity assessments which are necessary to keep existing medical devices on the market. These are calls which the European Commission has strenuously resisted to date, going so far as to issue a position paper blaming industry’s lack of preparedness for problems in the EU MDR and IVDR transition[5]. See our article on that here.

However, comments from Mr Pirovano at the ABHI Regulatory Conference now suggest that such calls to extend the EU MDR and IVDR transition periods might be gaining traction.

We understand that the European Commission’s Medical Device Coordination Group (MDCG) is holding a meeting with stakeholders on 24 October before its plenary meeting, at which clarifications to MDCG 2022-14 and “additional measures to avoid shortages of medical devices” are on the agenda. MDCG 2022-14 is the MDCG’s position paper and guidance document on how to enhance Notified Body capacity during the transition periods, so any resulting clarifications to this document should be interesting, but it will be particularly interesting to see what arises from discussions around “additional measures to avoid shortages of medical devices.” If nothing else, this will be an opportunity for stakeholders to air their dissatisfaction with the current state of play and increase the pressure on the European Commission to take further measures.

There is also a meeting of the EU’s Employment, Social Policy, Health and Consumer Affairs Council (Health) (EPSCO) scheduled for 9 December[6]. According to Mr Pirovano, MedTech Europe is aware that the EU MDR and IVDR transition is on the agenda, and has reason to believe that at least two EU Member States intend to call on the European Commission to make legislative amendments to the EU MDR and IVDR in order to extend the duration of the transition periods. It is one thing for the medtech industry and other private sector stakeholders to call for urgent action, but it is quite another when such calls are picked up and amplified by Member State officials at a ministerial level.

Nothing can yet be taken for granted, but it appears that the European Commission may soon come under irresistible pressure to grant generous extensions to the EU MDR and IVDR transition periods.

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[1] Polskie Centrum Badan I Certyfikajci S.A.
[2] Ente Certificazione Macchine Srl.
[3] Medical Devices Regulation (EU) 2017/745
[4] In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
[5] MDCG 2022-11: “Notice to manufacturers to ensure timely compliance with MDR requirements”
[6] EPSCO is the section of the Council of the EU which is attended by EU Member State health ministers.