Is the European Commission at last listening to the MedTech industry as further delays and the lack of notified bodies threaten the final implementation stages of the new device regulations?
In this context, the Medical Device Coordination Group (MDCG) published guidance document MDCG 2022-14, titled ‘Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs’, in late August, providing a 19-point action plan “to enhance notified body capacity, access to notified bodies and manufacturers’ preparedness in order to facilitate transition to the MDR and IVDR and to avoid shortage of medical devices”.
Although the document continues “The MDCG will implement and/or support the implementation of the actions listed in a timely manner”, review of the actions list reveals that most are targeted at manufacturers and notified bodies and not the MDCG or Commission. Publication of this MDCG document does, however, signal a softening of the Commission’s view published only a couple of months ago in MDCG 2022-11.
Reaction from industry has been lukewarm at best, with MedTech Europe and TEAM-NB stating that while issuing the action plan is a step in the right direction, it doesn’t go far enough to mitigate against some devices becoming unavailable either permanently or for a period of time. Indeed, one clinical sector has already warned of the possible non-availability of certain critical pediatric cardiology devices after the MDR becomes fully operational.
In addition, the now easier and less expensive access to the US market has become clearer with one manufacturer citing a ten-fold cost differential between an assessment against the MDR and clearance via the 510(k) process in the US.
Another aspect that is persuading manufacturers to enter the US market first is the availability of free advice from the US regulator (the Food and Drug Administration, FDA) via the ‘Pre-Sub’ process, whereas EU notified bodies are not allowed to ‘consult’ prior to review of device technical documentation.