Brussels, 21 April 2026 – AESGP welcomes the European Commission’s proposal to simplify and reduce the regulatory burden of the EU rules on medical devices and sees it as an important opportunity to address long–standing challenges in the implementation of the Medical Devices Regulation (MDR). In a new position paper, the self-care industry calls for targeted and proportionate improvements that strengthen legal certainty, predictability, and market access, without ever compromising patient and user safety or the good functioning of the Single Market.
AESGP supports targeted simplification
The Commission’s proposal addresses several shortcomings identified in the implementation of the MDR, including complex and costly procedures, inconsistent interpretations, and administrative inefficiencies that disproportionately affect manufacturers, in particular small and medium‑sized enterprises. By streamlining processes and enhancing legal certainty, the proposal has the potential to improve market access and support innovation, without compromising public health protection.
At the same time, AESGP considers that certain elements of the proposal would benefit from further refinement to ensure proportionality and to avoid carrying forward into EU law some existing weaknesses being enacted in informal procedures.
Key areas for improvement identified by AESGP
In its position paper, AESGP puts forward targeted recommendations in the following areas:
- Regulatory status decisions: Coordination mechanisms should be, transparent, and time‑bound, with compulsory stakeholder involvement (namely manufacturers and notified bodies), and challenges allowed to CE‑marked products should be rather exceptional and always evidence‑based.
- Predictable classification: Procedures to resolve classification questions should be clear, mandatory, and somewhat predictable, without creating new uncertainty for CE‑marked devices.
- Governance and expertise: Expert input should be independent, balanced, and informed by all relevant stakeholders, while the role of EMA should be limited to administrative support.
- Substance‑based devices: The MDR should better clarify between clinically relevant ancillary medicinal substances used with medical devices from substances having purely technological functions.
- Digitalisation: Digital tools, including electronic instructions for use, should benefit patients and lay users as well as professionals, with appropriate safeguards.
- Software classification: A risk‑based approach should be workable in practice, allowing genuinely low‑risk software to remain in Class I.
- Unintended reclassification: Proposed adjustment to the wording of Rule 21 would unintentionally expand its scope and risk reclassifying established low-risk products.
The amendments proposed by AESGP are practical and focused. They aim to reduce unnecessary regulatory burden, strengthen legal certainty and preserve patient safety, while supporting competitiveness and innovation in the European self‑care medical device sector.
AESGP looks forward to continued constructive engagement with EU institutions as discussions on the proposal progress.