On 10 August 2023, Team-NB, the European Association of Medical Devices Notified Bodes, published a position paper on the “New MDR Transition Timelines and Notified Body Capacity”.
In March 2023, the Council of the European Union approved new transitional periods for medical devices. With the initial transitional period, manufacturers of medical devices could place their devices on the market up to 2024. The new legacy period allows manufacturers to place their devices on the market until 2028, depending on the class, giving them more time to prepare for the transition.
The Team-NB position paper highlights challenging aspects of the new Regulation, such as MDCG guidances, the benefits and limitations of the new timelines, and the capacity of the notified body to assess the devices.
MDCG documents and unharmonised national procedures
Team-NB underlines the importance of MDCG guidance documents in helping all actors apply the MDR requirements. Nonetheless, the position paper states that implementing such documents also represents significant challenges to notified bodies and manufacturers, as notified bodies need time to integrate these guidance documents into their internal procedures.
At the same time, the procedures in the different member states are not harmonised. Therefore, notified bodies are bound to the interpretation of their member states. Consequently, this leads to further confusion and challenges.
Benefits and limitations of the new timelines
The new MDR timelines have many benefits. Among others, they prevent a sudden shortage of medical devices, give manufacturers more time to transition and enhance their preparedness for MDR requirements. Indeed, manufacturers must show their efforts in preparing for MDR compliance when applying for a new certification in a timely manner.
However, the NB position paper points out that the new provisions do not guarantee a successful transition. Notified bodies observed that the number of applications has decreased since the first draft of the new deadlines published at the end of 2022. With fixed deadlines, manufacturers might again start applying for their new certification too close to the deadlines, creating again notified bodies’ capacity challenges.
Notified body capacity
The position paper emphasizes the efforts of notified bodies to expand their operational capacity, for instance, through personnel recruitment and training. Regulators have also played their part in helping notified bodies to increase their capacity. Among the measures, there is the possibility to conduct hybrid audits (online and on-site) and to combine audits under the directives and the regulations for legacy devices.
Nonetheless, the NB-Team underlines various, outstanding aspects to improve their operational capacity further:
- Administrative workload reduction
- EUDAMED functionality
- Timely addition of designation codes
- A structured dialogue between regulators and stakeholders
Moreover, other aspects to enhance notified bodies’ capacity include:
- Stable regulatory environment
- Shorter timelines for notified body designation
- Alternative means of demonstrating competencies
- Facilitate and support the harmonisation efforts of notified bodies
- Complete and timely applications from manufacturers
- Availability of experts fulfilling the new requirements
Overall, the paper recognises and values the efforts to smooth the transition from the directives to the Regulation. Yet, it stresses that further coordinated actions of authorities and stakeholders are necessary.
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