Revision of the EU Medical Devices Regulation: ESIP calls for safeguards on patient and product safety (Position Paper)
On 16 December 2025, the European Commission presented its proposal for a targeted revision of the EU Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR), aimed to simplify the regulatory framework, reduce administrative burden and support timely access to medical devices and in-vitro diagnostics.
The European Social Insurance Platform (ESIP), representing statutory health insurers across the EU, acknowledges these objectives and the importance of maintaining a competitive and predictable regulatory environment. At the same time, efforts to deliver on simplification must remain fully compatible with robust safeguards for patient and product safety.
This is the core message of the ESIP position paper on the targeted revision of the EU Medical Devices Regulation (MDR). The paper supports proportionate simplification and calls for strong safeguards to:
Maintain robust clinical investigation requirements;
Strengthen post-market clinical follow-up, especially for the newly defined orphan devices (ODs) and breakthrough devices (BTDs);
Limit the initial certificate for ODs, BTDs, or other products developed through regulatory sandboxes and presenting uncertainties to five years;
Ensure that regulatory sandboxes are only used in exceptional cases where standard certification routes are not suitable;
Revise and narrow the list of Well-Established Technologies (WET) to ensure that only low-risk and well-understood devices are included;
Ensure that safety requirements for high-risk AI remain applicable to medical devices integrating AI components, both under the AI Act and through their full incorporation into sector-specific legislation;
Introduce EU-wide liability insurance requirements for medical device manufacturers and relevant economic operators;
Preserve Notified Body (NB) oversight; and
Maintain transparency on the mandatory Summary of Safey and Clinical Performance, information on products withdrawn from the market or affected by production interruptions, as well as on corrective and preventive actions linked to post-market surveillance.
The MDR and IVDR were introduced in response to serious regulatory failures, including the PIP breast implant scandal, which exposed the consequences of weak oversight, insufficient clinical evidence and gaps in market surveillance. Any revision of the framework must therefore avoid reopening the very loopholes these regulations were designed to close.
In conclusion, simplification and competitiveness must not come at the expense of patient safety, product safety or robust clinical evidence. These safeguards are the foundation of public trust in the EU medical devices framework and must remain central to the upcoming negotiations.