Medical Devices
In March 2023, EU Regulation 2023/607 extending the transition period for certain medical devices under the MDR became applicable. AESGP welcomed the adoption and publication of this legal text given its mitigation of the imminent risk of shortages of medical devices and, therefore, ensuring access to safe medical devices for patients across Europe (see also AESGP statement welcoming the MDR amendment here). AESGP actively followed the implementation process of the Regulation and contributed actively to the development of European Commission’s Q&A on practical aspects related to the implementation of Regulation 2023/607. In addition, AESGP jointly developed with other sectorial associations a manufacturer’s declaration template to facilitate the declaration of manufacturer’s with respect to Regulation 2023/607 (the template has been made available on AESGP’s website here).
AESGP has remained vocal and contributed actively to the regulatory discussions within the Medical Devices Coordination Group (MDCG), highlighting the need to address the structural issues in the MDR implementation process when it comes to the regulatory structure and governance. To this end, AESGP brought forward certain proposals in close collaboration with other industry associations, including calls for:
- Structured dialogues between manufacturers and notified bodies, notably before conformity assessments;
- Increased predictability of timelines in conformity assessments;
- Increased cost transparency and cost efficiency associated with review processes;
- Reduced administrative burden for notified bodies and greater focus on safety and performance aspects during conformity assessments;
- More consistent and streamlined review processes; with a recognition of notified body audit reports amongst notified bodies.
In view of the ongoing and major challenges in the overall implementation of the MDR, AESGP emphasized the need for strong and coordinated collaboration between stakeholders at EU level with the aim to: (1) conduct an in-depth analysis of the current system and its shortcomings; and (2) identify potential measures and solutions post 2024 together with an assessment of their impact.
In this context, AESGP has taken part and contributed to relevant European Commission initiatives at European level. For example, the study on regulatory governance and innovation in the field of medical devices, which has been launched in September 2023 and aims at identifying key benefits and challenges of the governance structure of the MDR/IVDR and making proposals for optimising the governance structure. In parallel, AESGP commenced work with its members on a position paper setting out measures to improve and optimize the existing regulatory system applicable to medical devices.
AESGP welcomed and supported the Commission’s announcement in December 2023 that a legislative proposal amending the provisions on EUDAMED would be tabled in January 2024. It reminded the European Commission, with other stakeholder associations, of what were seen as necessary prerequisites before EUDAMED become mandatory. In particular, AESGP co-signed a joint industry letter (see the statement here) welcoming the mandatory use of EUDAMED as long as the following features are ensured:
1. The modules are fully developed, tested, audited, and ready for practical implementation.
2. EUDAMED enables the most efficient use of Notified Body and Manufacturer resources.
3. Realistic and reliable implementation and transition timelines are provided.
4. Redundancy in National Databases is eliminated.
International Medical Devices Regulators Forum (IMDRF) Activities
In 2023, The EU took the rotating role of Chair of the IMDRF Management Committee. The EU hosted IMDRF meetings in Brussels in March 2023 and in Berlin in September 2023 in which AESGP was represented as an active participant.
The meeting happening in Brussels particularly covered the life cycle of medical devices and the importance of post-market-related activities, with a deep dive on Real-World-Evidence.
In Berlin, the meeting covered issues related to Specialized Regulatory Pathways.
Data on Self-Care Medical Devices
Towards the end of 2023, AESGP started working in collaboration with IQVIA on a white paper on the self-care medical devices market in Europe. It made use of the previous data analysis undertaken by IQVIA and AESGP with regard to the market size and trends for the self-care medical devices market across Europe. The white paper was finalised and published in February 2024.