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

Right from the preamble, the situation was set out with dramatic consistency in relation to the true state of affairs.

[…] The MDCG recognises that significant and urgent challenges remain in ensuring sufficient capacity of notified bodies and readiness of manufacturers in order to allow medical devices and in vitro diagnostic medical devices to be certified […]. The data gathered to date indicate that there are multiple causes which require a mix of solutions.
[…] Health Ministers expressed their concerns that these challenges, if left unaddressed, may lead to disruption of supply of devices needed pfor health systems and patients and may jeopardise the access of innovative medical devices to the European market. Health Ministers called on the MDCG to propose solutions to address immediate challenges as a matter of urgency.
The proposed actions outlined in this document are intended to improve the efficiency of application of the regulatory requirements, rather than reducing, avoiding or removing requirements, in particular in relation to safety. […]

In response to the call for help from those in the industry, the Medical Device Coordination Group responded with a series of tips to improve the efficiency of the application of regulatory requirements.

For notified bodies

• It is suggested to make use of hybrid audits if deemed useful.
• In order to avoid unnecessary duplication of work, it is encouraged to leverage evidence, or components thereof, from previous assessments, provided that duly qualified notified body personnel deem the previous assessments body valid and properly substantiated.
• Make full use of the flexibility granted by special guidelines, focussing on assessment of compliance with MDR/IVDR requirements instead of surveillance of compliance with Directives’ requirements. A further guideline will be issued in this regard.
• The MDCG will review its guidance with a view to eliminate administrative workload of notified bodies or undue limitations.
• The MDCG considers that it should be ensured as soon as possible that notified bodies can upload relevant information machine-to-machine.
• In addition, notified bodies should rationalise and streamline internal administrative procedures, and ensure that proper conformity assessments are carried out in a timely and efficient manner in accordance with the Regulations.
• The MDCG welcomes the request to modify the frequency of complete re-assessments of notified bodies.
• All parties involved in the process of notifying bodies are urged to speed up the handling of files.
• The MDCG will look at ways to speed up the process of designation of the bodies.
• The MDCG is committed to prioritising the evaluation of solutions that can increase the operational capacity of the bodies.
• As regards the guidance documents, the MDCG reminds that their objective is to assist, and flexibility should be allowed on how to demonstrate compliance with mandatory requirements, even irrespective of their content. Furthermore, since these guidance documents are constantly being issued, organisations should avoid considering guidelines issued after the certification practice has been initiated.

Access to notified bodies

• The MDCG reminds notified bodies of their obligation to make their standard fees publicly available in a way that makes them easy to compare with those of other bodies.
• The MDCG calls on notified bodies to develop schemes in order to allocate capacity also to SMEs and first-time applicants.

Increased preparedness of manufacturers

• The MDCG reminds manufacturers to read the MDCG 2022-11, which we have covered in this article.
• The MDCG encourages notified bodies and manufacturers to organise structured dialogues before and during the conformity assessment process aimed at regulatory procedures where this is useful to enhance the efficiency and predictability of the conformity assessment process. Such dialogues should not be considered consultancy service.
• The MDCG urges all those involved in the conformity assessment process to prepare training courses and guidelines to help manufacturers better prepare themselves for the certification process.

Other actions facilitating transition

• Provision of additional guidance for:
  • The practical application of Article 61 MDR (clinical evaluation) and Article 56 IVDR (performance evaluation and clinical trials).
  • Make appropriate use of MDCG guidance on clinical evidence for legacy devices and for demonstrating equivalence, combined with the requirement to carry out PMCF/PMPF studies.
• The MDCG acknowledges the specific situation of ‘orphan devices’ and will pursue work with a view to providing a definition for ‘orphan devices’.
• The MDCG urges medicines authorities to accept and efficiently process consultations by notified bodies regarding medical devices incorporating an ancillary medicinal substance.

Once again, the industry is making a clear and strong demand for assistance, yet the MDCG responds by reiterating well-known concepts.

The only and last bastion of hope in this document? The possibility that others will emerge and that decisive actions will be taken to tackle the situation at hand.

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