MDCG 2022-08: Treating a Self-Inflicted Wound

The MDCG 2022-08 guideline, issued in August 2022, raises an alarm about the possibility of medical device shortages due to the complexity of implementing the Regulation.

From the preamble, the situation is presented with dramatic coherence regarding the actual state of affairs.

[…] The MDCG recognizes that significant and urgent challenges remain in ensuring sufficient capacity of notified bodies and manufacturer readiness to enable certification of medical devices […]. Data collected to date indicate that there are multiple causes requiring a mix of solutions.
[…] Health Ministers have expressed their concerns that these challenges, if not addressed, may lead to disruption in the supply of necessary devices for healthcare systems and patients and may compromise access to innovative medical devices in the European market. Health Ministers have called on the MDCG to propose solutions to address immediate challenges urgently.
The proposed actions outlined in this document are aimed at improving the efficiency of applying regulatory requirements, rather than reducing, avoiding or eliminating requirements, particularly in relation to safety. […]

In response to the request for help from those working in the sector, the Medical Device Coordination Group has responded with a series of recommendations to improve the efficiency of applying regulatory requirements.

For Notified Bodies

• It is suggested to perform hybrid audits if deemed useful.
• They are encouraged to use previous assessments, or parts of them, to avoid unnecessary duplication of work. Provided, however, that appropriately qualified personnel consider them valid and adequately justified.
• Rather than dedicating so much time to MDD surveillances, use the flexibility granted by specific guidelines to dedicate part of that time to the transition to MDR. An additional guideline will be issued on this matter.
• The MDCG will review its own guidelines that contain apparently unnecessary administrative workloads for Notified Bodies.
• The MDCG recognizes that it would be useful to allow Notified Bodies more direct (machine-to-machine) use of Eudamed.
• It is also suggested to dedicate time to staff training while streamlining internal administrative procedures and ensuring that assessments are carried out in a timely and efficient manner in compliance with the Regulation.
• The MDCG accepts the request to dilute the number of reassessments of Notified Body notifications.
• All parties involved in the Notified Body notification process are urged to accelerate the handling times of applications.
• The MDCG will seek to understand how to speed up the extension of Notified Bodies’ designation scopes.
• The MDCG commits to prioritizing the evaluation of solutions that can increase the operational capacity of Notified Bodies.
• Regarding guidelines, the MDCG reminds that they are, indeed, guidelines and flexibility should be granted on how to demonstrate compliance with mandatory requirements, even regardless of their content. Moreover, considering that these guidelines are continuously being issued, Notified Bodies should avoid considering guidelines issued after the start of the certification process.

Access to Notified Bodies

• The MDCG reminds of the obligation to make standard fees public, through display methods that allow easy comparison with the fees of other Notified Bodies.
• The MDCG urges Notified Bodies to develop operational schemes to allocate resources for SMEs and new clients as well.

Increasing Manufacturer Readiness

• The MDCG reminds manufacturers to read MDCG 2022-11, which we covered in this article.
• Dialogue between the Notified Body and the manufacturer is encouraged before and during the certification process, to improve the efficiency and predictability of the conformity assessment process, without, however, crossing into consultation.
• The MDCG urges all those involved in the conformity assessment process to develop training courses and guidelines to help manufacturers arrive more prepared for the certification process.

Other Actions to Facilitate the Transition

• Provide new guidelines for:
  • The practical application of Article 61 MDR (clinical evaluation) and Article 56 IVDR (performance evaluation and clinical evidence).
  • Making appropriate use of MDCG guidelines on clinical evidence for legacy devices and for demonstrating equivalence; in combination with requirements for conducting PMCF/PMPF.
• The MDCG acknowledges the presence of orphan devices and will act accordingly to issue specific guidelines to, first of all, provide a definition of this term.
• The MDCG urges pharmaceutical authorities to simplify and increase support to Notified Bodies dealing with devices incorporating an ancillary medicinal substance.

Once again, industry operators launch a clear and strong request for help, yet the MDCG responds by reiterating concepts that are already known.

The only and last bastion of hope in this document? The possibility that others will emerge and that these will be resolutive actions regarding the current situation.

Support for the transition to MDR and IVDR is an ongoing process, which may require the addition of actions to those listed in this summary document.