The RAPS Convergence 2023 event came to a close on October 5, 2023, in Montreal, Canada, where regulatory professionals gathered to engage in extensive discussions covering various aspects of regulation. One prominent subject of discussion revolved around notified bodies and their role in the European Medical Devices Regulation (MDR) 2017/745.
Notified bodies have been actively working to harmonize their activities to ensure a smooth transition under the MDR. Representatives from these bodies have been collaborating closely, leading to successful outcomes like the publication of Team-NB Best Practice guidance documents related to the MDR and the In Vitro Diagnostic Devices Regulation (IVDR) 2017/746.
Several key themes and topics dominated the discussions:
Data Collection on Notified Bodies: Considerable data has been collected on notified bodies, and their performance is under scrutiny. Article 121 of the MDR expects the European Commission (EC) to evaluate their performance. To this end, the EC commissioned a study on regulatory governance and innovation in the field of medical devices, with the first stakeholder meeting held in September. Additionally, a survey on notified bodies was published by the EC in July 2023, using data up to the end of March. However, there were concerns raised by notified body representatives that despite their continuous provision of data, updates have yet to be released by the EC.
MDR Deadline of May 26, 2024: The looming deadline of May 26, 2024, as per Regulation 2023/607, requires manufacturers to have submitted applications for MDR certificates to continue marketing legacy devices. Notified bodies assured that they can accept and review these applications. While the MDR specifies the application process, there may be variations among different notified bodies. Manufacturers are advised not to delay and should engage with their designated MDR-notified body or potential ones to initiate the application process.
Structured Dialogues Between Manufacturers and Notified Bodies: The guidance provided by MDCG 2022-14 encourages the use of structured dialogues between manufacturers and notified bodies. These dialogues can help expedite the notified body review process. Despite the guidance published in August 2022, it was noted that such dialogues have been infrequent. However, there is optimism that more guidance regarding structured dialogues will be provided in the future.
In conclusion, there are ongoing initiatives aimed at enhancing the conformity assessment process with notified bodies, and the EC is actively overseeing the EU regulatory landscape. Both notified bodies and industry representatives remain positive about achieving compliance with the MDR. As the first deadline is less than eight months away, manufacturers must engage with their designated MDR-notified bodies promptly and maintain steady progress toward compliance. The industry as a whole is committed to working towards MDR compliance and navigating the evolving regulatory landscape effectively.
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