Parliament discusses targeted revisions to promote simplification and innovation

With the presentation of his draft report  in the Committee on Public Health (SANT), Rapporteur Oliver Schenk (EPP, Germany) launched the European Parliament’s work on the targeted revision of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) on 14 July. The European Commission had presented its corresponding legislative proposal in December last year. During the exchange of views, Members from across the political spectrum broadly supported the objective of making the existing rules more practical. At the same time, many MEPs stressed that regulatory simplification must not come at the expense of patient safety or robust clinical evidence.

Main elements of the draft report

Oliver Schenk presented his draft report under the guiding principle of combining innovation and patient safety. The objective of the reform is to strengthen Europe’s competitiveness while preserving the high level of protection provided by the MDR and IVDR. The draft report therefore follows a risk-based and innovation-oriented approach.

Its key proposals include more predictable conformity assessment procedures, prioritised pathways for breakthrough and orphan devices, and a new category of so-called “Niche Devices” intended for products designed for small patient populations. The report also provides for mandatory post-market clinical follow-up (PMCF) measures and initial certifications limited to five years. Further key elements include a stronger role for scientific Expert Panels, tighter equivalence requirements, and the retention of key liability provisions, including mandatory financial coverage for liable economic operators. In addition, the report proposes measures to support digitalisation and reduce administrative burden, such as electronic instructions for use and reduced documentation requirements.

Parliament supports the overall reform approach

During the debate, many Members supported the overall direction of the draft report, while placing different emphasis on specific policy issues. Alongside broader political questions, the discussion was largely shaped by technical details. Particular attention was given to the regulation of AI-enabled medical devices and its interface with the AI Act, as well as to the reprocessing of single-use devices. While some Members called for greater flexibility for hospitals in this area, others argued in favour of maintaining the existing rules.

DSV welcomes key elements of the draft

From the perspective of the DSV, the draft report provides a balanced basis for the further parliamentary negotiations. It refines a number of the European Commission’s proposals in favour of greater patient safety and more robust clinical evidence. The DSV particularly welcomes the retention of product liability for manufacturers and authorised representatives, including appropriate financial coverage, as this preserves a key element of patient protection; the restriction of the extended equivalence provisions for high-risk devices, as this strengthens the requirements for clinical evidence; and the stronger involvement of scientific Expert Panels in order to provide a more robust scientific basis for regulatory decisions. The DSV also welcomes stricter conditions for prioritised procedures for breakthrough and orphan devices, ensuring that accelerated pathways remain linked to high standards of safety and evidence, as well as the clarification that regulatory sandboxes must not be associated with lower regulatory requirements, thereby safeguarding the high level of protection established by the MDR and IVDR.

DSV sees further need for improvement

At the same time, the DSV considers that further adjustments are needed in certain areas. Clinical evidence should continue to remain the cornerstone of conformity assessment and should not be weakened through a greater reliance on non-clinical data, as robust clinical evidence is indispensable for ensuring patient safety, particularly for high-risk devices. The DSV also takes a critical view of the proposed reduction in transparency requirements for in-house devices, as this could undermine traceability and market transparency, as well as the introduction of an additional category of so-called “Niche Devices”, since its regulatory added value compared with the existing specific provisions for orphan devices has not yet been sufficiently demonstrated. In addition, the DSV considers that further clarification is needed regarding the classification of software and AI-enabled medical devices in order to ensure a consistently high level of safety and risk-based regulation.

Outlook

The presentation of the draft report marks the beginning of the Parliament’s detailed work on the proposal. Amendments may be tabled until 20 July. The vote in the SANT Committee is scheduled for 3 December, after which the European Parliament is expected to adopt its position in early 2027. The Council, under the Irish Presidency, is also aiming to reach a General Approach by the end of 2026. The DSV will continue to contribute constructively to the negotiations and advocate for a balanced revision of the MDR and IVDR. The DSV statement on the draft report can be found here.