The resolution on the urgent need to revise the Medical Devices Regulation, presented by several European parliamentarians, to the European Commission was approved on Otober 23rd, 2024.
This resolution calls on the European Commission to intervene with a systematic revision of all relevant articles, and with specific measures on the current text to resolve the most pressing challenges and bottlenecks in the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) by the end of Q1 2025.
Furthermore, the document calls on the Commission to make full use of legislative and non-legislative tools to resolve issues of divergent interpretation and of practical application to streamline the regulatory process.
The main objectives of the resolution are:
- to deplore the risk of shortages of medical devices and the lack of access to certain medical devices and in vitro diagnostics in parts of the EU;
- to ensure that there are sufficient resources to meet the market demand in a timely manner;
- the creation of transparent and binding timelines and costs (transparency in notified bodies’ fees and fee structures), including clock stops for procedural steps in conformity assessment by notified bodies;
- making assessments of changes to medical technologies more efficient;
- building an accelerated pathway for breakthrough innovation, and adapting certification timelines to follow a life-cycle approach.
In the resolution particular attention is required by the Commision on the need to protect health data collected by e-health applications, and on the introduction of adapted rules for orphan and paediatric medical devices, without compromising patient safety.
MedTech Europe, in a note posted on October 23rd, welcomed the resolution of the European Parliament.
MedTech Europe remains committed to working closely with the European Commission, European Parliament and Member States to ensure that the MDR and IVDR meet their objectives and foster a regulatory environment that supports innovation, protects public health and maintains the availability of life-saving medical devices across Europe.
In addition, the core group of medical devices of Medicines Agencies (HMA, heads of EU Competent Authorities), on October 18th, sent a letter to the Director General for Health and Food Safety of the European Commission (EC) expressing their concerns and stating that they “strongly believe that further legislative change must follow appropriate analysis, careful consideration, affirmation of core principles and impact assessment to avoid further unintended consequences.”
The letter focuses on the concerns of the impact derived from the implementation of new proposals, which are necessary, but the timeline and the measures must be appropriate and sufficient. It is important to take into account that this regulatory system has significant implications for citizens, patients, healthcare providers as well as the competitiveness of the industry and the integrity of the single market.
In conclusion, it is clear the need to simplify the regulatory framework, improve transparency on costs and timelines, and eliminate unnecessary administrative work, without compromising patient safety.
References:
https://www.europarl.europa.eu/doceo/document/TA-10-2024-0028_EN.pdf
https://www.hma.eu/fileadmin/dateien/Medical_Devices/CGMD/241018_Letter.pdf
