EPF responds to European Commission proposal on medical devices regulations

The European Patients’ Forum (EPF) welcomes the European Commission’s proposal to amend the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), recognising its potential to address ongoing implementation challenges and prevent disruptions in patient access to essential medical devices.

While EPF supports efforts to strengthen coordination, introduce pathways for breakthrough and orphan devices, and maintain patient safety at the core of the framework, it also raises important concerns. These include reduced transparency, insufficient patient involvement in decision-making, and potential risks linked to increased reliance on simplified regulatory requirements.

To address these issues, EPF puts forward several key recommendations:

• Preserve strong oversight throughout the device lifecycle – this includes harmonising evidence requirements through e.g. common specifications and removing provisions aimed at simplifying reliance on equivalence, and ensuring that simplification measures do not weaken post-market surveillance and AI oversight.
• Improve vigilance and response to safety events – this includes establishing clear timelines for investigation, risk assessment, and response to safety events across the EU, as well as strengthened coordination between national competent authorities and timely communication to patients.
• Strengthen patient involvement in governance and regulatory decision-making – this means empowering patients to contribute to decisions that affect them through the creation of a specific platform for dialogue under the MDCG, similar to the EMA Patient and Consumer Working Party (PCWP), with adequate financial support. Other measures include the inclusion of patients in expert panels and the establishment of reporting channels for safety issues.
• Improve transparency and access to information for patients – prioritise the roll-out of a clear, searchable, and accessible EUDAMED, including expanding available information to strengthen trust in the clinical evidence base and notified bodies’ decisions, and maintain implant cards for all implantable devices, including well-established technologies (WET)
• Address unmet patients’ needs and innovation gaps – ensure breakthrough and orphan pathways work in practice in a decentralised system and effectively address patients’ needs, with a particular focus on adequate oversight and post-market follow-up.
• Ensure adequate resources, governance structures, support mechanisms for sharing of best practices and commitment across the system to ensure successful implementation. Further, recognise patient organisations as real partners in the system to share data and experiences from their community and amplify public health communications.

Reaffirming its commitment to a patient-centred approach, EPF stands ready to work with EU institutions to ensure that the revised regulatory framework guarantees both high safety standards and timely, equitable access to medical innovation across Europe.

Read the full position paper for more details.