The Medical Device Coordination Group (“MDCG”) has published a new position paper (MDCG 2022-14) acknowledging the significant and urgent lack of capacity of EU notified bodies. It acknowledges the risk that this could lead to many existing and new medical devices and in vitro diagnostic medical devices (“IVDs”) not undergoing timely conformity assessments under Regulation (EU) 2017/745 (the “MDR”) or Regulation (EU) 2017/746 (the “IVDR”) (together, the “Regulations”)). In turn, this could mean patients miss out on access to, potentially, lifesaving medical devices and IVDs. As such, the MDCG has suggested actions for mitigating such challenges. Importantly, there is a focus on flexibility and pragmatism.
The introduction of the Regulations has meant that many new and existing medical devices and IVDs will need to undergo a conformity assessment by a notified body in the next few years in order to continue to be placed on the market in the EU. Additionally, the Regulations require the re-designation of notified bodies to allow them to conduct conformity assessments under the Regulations. The time-consuming process of such re-designation has led to there being an insufficient number of notified bodies available to conduct conformity assessments under the Regulations.
Thus, a lack of notified body capacity and a large number of devices requiring conformity assessment means there is a risk devices will not be CE marked prior to expiry of applicable transitional provisions, which could result in a disruption to the supply of devices and a significant knock-on impact for patients.
The MDCG’s latest publication both recognizes and attempts to assuage these concerns by proposing counter-actions aimed 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”.
This blog post seeks to summarize the MDCG’s recommendations.
Increase notified body capacity
The MDCG makes eleven (11) recommendations that aim to increase notified body capacity.
It advises that notified bodies:
- use hybrid audits;
- avoid unnecessary duplication of work (e.g., by leveraging evidence and previous assessment results generated under the prior directives);
- rationale and streamline internal administrative processes; and
- be flexible when carrying out “appropriate surveillance” of legacy devices (e.g., by combining audits under the prior directives and the Regulations).
Relevant parties are advised to:
- foster capacity-building in new and existing notified bodies; and
- make every effort to speed up the process for designation and notification of conformity assessment bodies.
The MDCG commits to:
- review its guidance to “eliminate [the] administrative workload” of notified bodies”;
- explore ways of adding codes to the designation of notified bodies in a timely manner (looking at the depth of assessment and ways to make it faster); and
- prioritize its own actions aimed at contributing to notified body capacity (including revision of its guidance on the meaning of “personnel employed by the notified body”, MDCG 2019-6 rev. 3).
Additionally, the MDCG calls for the Eudamed framework, which allows machine-to-machine upload of information, to be developed and deployed as soon as possible.
Finally, and importantly, the MDCG clarifies the status of its guidance and how it should be used. It states:
“As regards the status of MDCG guidance documents, MDCG reminds that their main objective is to assist economic operators, notified bodies and competent authorities to apply the legal requirements in a harmonised way, providing possible solutions endorsed by the MDCG. Having regard to the status of guidance documents, economic operators and notified bodies should be allowed flexibility as to how to demonstrate compliance with legal requirements. Moreover, reasonable time needs to be given to integrate new guidance in the relevant systems and/or to apply them. That means that new guidance should not be applied to ongoing processes or applications already launched by a conformity assessment body for designation and/or a manufacturer for conformity assessment, unless application of such guidance yields increased efficiency of the process.” (emphasis added)
Thus, the MDCG takes a pragmatic approach by indicating that those undergoing assessments under the Regulations should not have to contend with new guidance published after an application has been submitted moving the goal posts mid-assessment. Rather, new guidance should apply only to subsequent applications.
Increase access to notified bodies
The second category of MDCG suggestions are those focusing on “access to notified bodies”. The first of these emphasizes the obligation of notified bodies to make their standard fees publicly available, to allow manufacturers, particularly SMEs that may have fee concerns, to make informed decisions. The MDCG also suggests that notified bodies develop schemes to allow allocation of capacity for SME manufacturers and first-time applicants, ensuring that such entities have access to the requisite conformity assessments.
Increase preparedness of manufacturers
The MDCG’s position paper also offers suggestions with respect to increasing the preparedness of manufacturers. The MDCG reiterates its previous advice of ensuring timely compliance with MDR and IVDR requirements (MDCG 2022-11). However, it notes that notified bodies can support this as the MDCG also encourages “structured dialogues” between notified bodies and manufacturers both before and during the conformity assessment, where these will enhance the efficiency and predictability of the process.
The MDCG recommends that all parties involved in the assessment process increase communication and educational offerings to manufacturers via webinars, workshops, and targeted feedback sessions. The MDCG provides the example of notified bodies working on common application guidelines for manufacturers, alongside national authorities promoting engagement with relevant stakeholders at national level.
Other actions facilitating transition to MDR/IVDR and/or shortage of devices
In its final category of recommendations, the MDCG generally encourages greater pragmatism and a reduction in the complexity of conformity assessments for safe and effective legacy devices (including orphan devices). In pursuit of such, the MDCG proposes:
- The publication of additional guidance in respect of the practical application of Article 61 MDR (clinical evaluation), and possibly Article 56 IVDR (performance evaluation and clinical evidence), and to make appropriate use of the MDCG’s guidance on clinical evaluation equivalence for legacy devices.
- The publication of specific guidance (including a definition) on so-called ‘orphan devices’.
- Encouraging medicines authorities to accept and efficiently process consultations by notified bodies regarding medical devices incorporating ancillary medical substances and companion diagnostics. In particular, allowing expedited reviews for devices already certified following consultation with a medicines authority under the prior directives.
The MDCG also notes that it will endeavour to formulate a “coordinated, transparent and coherent approach” in respect of derogations from applicable conformity assessment procedures (i.e., in the interest of public health, patient safety or patient health).
Although this is merely a position paper, it shows that the MDCG and regulators are acutely aware of the lack of capacity of notified bodies and the impact of the delay in notified body review. Whether these recommendations will lead to any concrete changes is yet to be seen but the recommendations may encourage notified bodies to take a more pragmatic and flexible approach to the conformity assessment of medical devices and IVDs. This could help manufacturers complete the conformity assessment (and ultimately CE mark their devices) under the Regulations more efficiently. The further guidance that the MDCG indicates is forthcoming is also encouraging.