MDCG releases guidance on addressing lack of Notified Body capacity


By way of update, as of 22 September 2022, there are:

  • 32 Notified Bodies designated for the EU Medical Device Regulation (MDR)[1] and
  • seven Notified Bodies designated for the EU In Vitro Diagnostic Medical Device Regulation (IVDR)[2].

We have discussed the role of Notified Bodies and the critical need for increased Notified Body capacity at length, including here and here.

Ultimately, there are not enough Notified Bodies to avoid bottlenecks simply to keep existing medical devices and IVDs on the market in light of the EU’s new regulatory landscape, let alone bringing new and innovative devices to market.

This fact has now been acknowledged by all stakeholders, including the European Commission.

In response to concerns voiced by Health Ministers at the EPSCO Council meeting in June 2022, the Medical Device Coordination Group (MDCG) was instructed to propose solutions to address the capacity issue. The resultant MDCG guidance[3], published in August, acknowledges the “significant and urgent challenges”, and encourages an efficient and pragmatic approach to meeting the regulatory requirements. The only really tangible suggestion is to make use of hybrid auditing.

While this guidance is well-intentioned, it is largely wishful thinking and does little to tackle the underlying capacity issues. The guidance suggests very little in the way of practical steps that Notified Bodies and manufacturers won’t already be taking. It also does not include any relief from sanctions if a manufacturer is unable to obtain CE marking in time due to the Conformity Assessment backlog, other than briefly acknowledging the ‘periods of grace’ provisions in the MDR and IVDR.

We echo our previous sentiments that not enough is being done to address the lack of Notified Body capacity and this will likely result in certain medical devices no longer being available on the market.

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[1] Regulation (EU) 2017/745
[2] Regulation (EU) 2017/746