August 17, 2023
The European Association of Medical Devices Notified Bodies, Team-NB, released a white paper on August 10, 2023, called “New MDR Transition Timelines and Notified Body Capacity” (TEAM-NB Position Paper). The white paper presents the developments since 2021 and describes the current regulatory situation for manufacturers and Notified Bodies of from the latest amendments through the transitional provisions of Regulation (EU) 2023/607 to the Medical Devices Regulation (MDR, 2017/745).
Team-NB outlines the recent challenges and changes in the current state of Notified Body capacity, such as the greater flexibility when reviewing MDR applications in time through the use of items addressed in MDCG 2022-14. But Team-NB also requests that manufacturers should file timely MDR applications and should submit complete technical documentation files compliant with the MDR to secure a successful transition and timely review.
Introduction to the Notified Body capacity position paper
The position paper presents reasons (risk of medical device shortages as well as delayed and incomplete applications) why it was necessary to amend the MDR transition timelines again in order to give manufacturers more time to bring existing products into compliance with the MDR.
Team NB summarizes the results from their surveys conducted between 2021 and 2023 to identify the number of applications (and Certificates) from manufacturers and the respective capacity of the Notified Body. It is worth reviewing these survey results, as they provide a detailed picture of the real number of MDR applications. For example, the information that many of these applications include a smaller scope than the one covered by the directive certificates (which can be due to a lack of readiness of MDR Technical Documentation Files for numerous devices, as well as a staggered approach taken by manufacturers to certify their product portfolio gradually).
Further, Team-NB shares an overview of the volume of Medical Device Coordinating Group (MDCG) documents and unharmonized national procedures. It calculates that the MDCG has produced more than 80 documents amounting to 1,500 pages of guidance. And Team-NB opines that the “sheer volume” “necessitates an extensive allocation of resources.”
Measures to guarantee sufficient Notified Body capacity
Team-NB posits seven factors that would be critical to facilitate sufficient Notified Body capacity. Team-NB explains the background (implemented solutions and activities) and discusses the current remaining limitations.
Factors that can facilitate Notified Body capacity:
- Implementation of MDCG 2022-14 measures
- Stable regulatory environment
- Shorter timelines for Notified Body designation
- Alternative means of demonstrating competencies
- Facilitate and support the harmonization efforts of Notified Bodies
- Complete and timely applications from manufacturers
- Availability of experts fulfilling the new requirements
There is a discussion related to all of these factors. Of note, the limited functionality of EUDAMED is a challenge with the future duplication of work, as current data is only uploaded into national databases (MDCG 2022-14, action item 5, EUDAMED).
Measures to enhance manufacturer’s complete and timely MDR applications
In many sections, Notified Bodies urge manufacturers to submit their complete MDR application as soon as possible, and not to wait until the last moment, as new peaks in Notified Body workload could arise. Team-NB specifically outlines how crucial it is for manufacturers to liaise with their Notified Bodies at their earliest convenience and submit all their applications now in order to successfully manage this transition together. With helpful guidance documents now available such as the Team-NB best practice guide on MDR Technical Documentation published in October 2022, there is detailed guidance for manufacturers. This should result in better data and reduce the questions during the Notified Body review and finally, should result in a more efficient and faster review time- and more timely certificates.
Amendment of the MDR transition timelines
The white paper summarizes the historical changes and challenges since the amendment of the MDR transition timelines and tries to establish the current regulatory environment. Here, Team-NB expresses their concerns about the current limited number and low quality of MDR applications, which reflect that the MDR transition process is still slow or even has stopped for many manufacturers after Regulation 2023/607. With the latest substantial investment and preparations made by Notified Bodies (staff, expertise, infrastructure) to accommodate the transition and provide enough capacity for manufacturers, it is now pivotal for manufacturers to promptly utilize the available Notified Bodies by submitting their applications now.
Team NB notes that timely and effective coordination between all stakeholders is paramount to prevent potential peaks in demand for Notified Body capacity around the new deadlines set by Regulation 2023/607, which includes application submission in 2024, and finalization of certification processes in 2027/2028. Notified Bodies are fully committed to playing their part in making this work.
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