Medical devices are essential in allergy and respiratory care. For people with allergy, asthma and COPD, this means tools such as inhalers and spacers, nebulisers, oxygen equipment, allergy test kits, autoinjectors and digital monitors that support diagnosis, treatment and prevention.
EFA has submitted a response, developed with our patient community, to the European Commission’s call for evidence on the targeted revision of the EU Regulations on medical devices (MDR) and in vitro diagnostics (IVDR). The submission explains what the reform should deliver: safe devices, clear rules and reliable access across countries.
Medical devices are important to allergy and respiratory patients
EFA has engaged in the Medical Device Regulation process since 2012. The European Commission is reviewing how the MDR and IVDR work in practice, while the EU Health Technology Assessment Regulation became applicable in early 2025 and will begin joint EU assessments of selected high-risk devices in 2026. In March 2025, EFA responded to the Commission’s evaluation and highlighted problems in the legal framework, stressing that any simplification of development, assessment, authorisation and surveillance must not weaken patient safety.
MDR, IVDR and HTAR (Health Technology Assessment Regulation) should align on evidence and timelines to keep protection high and access reliable. This consultation is a key opportunity to embed the patient voice at the heart of implementation. Drawing on our community’s input, we set out four recommendations.
EFA recommendations for a safe and patient-proof MDR
Medical device regulatory procedure: EFA welcomes efforts to simplify EU medical device regulations but regrets the lack of a full impact assessment of the revision. The current fragmented system risks patient safety and limits patient involvement. EFA calls for a centralised EU procedure for high-risk devices, stronger patient representation in regulatory bodies, and specialised notified bodies to ensure consistent, high-quality assessments and equal access across Europe.
Access to care: Medical device shortages in Europe severely impact allergy and respiratory patients’ mental health, causing anxiety, depression and isolation. EFA urges a centralised EU procedure for high-risk devices to ensure safety and equal access. Fragmented national systems delay care and exclude patient voices. Involving patients in regulatory bodies and creating specialised notified bodies can improve safety and reduce psychological distress.
Prevention of respiratory diseases: The MDR supports respiratory disease management by ensuring device safety through rigorous evaluation and surveillance. For allergy and airways diseases patients, reliable devices are vital. EFA stresses that streamlining must not weaken safety standards. A key gap is patient education. Ongoing training is essential but often lacking.
Investing in healthcare systems and innovation: EU-made medical devices are globally valued for their high standards, a key competitive advantage. While streamlining MDR reduces burdens and speeds market access, patient safety must remain paramount. MDR enables innovation, like AI respiratory tools, improving care for asthma and COPD. EFA urges highlighting these benefits and stresses that Member States' actions support, not hinder, EU-wide goals for better device regulation.
Next steps
After reviewing the comments from the stakeholder community, DG SANTE is set to publish the legislative revision by the end of the year. EFA looks forward to seeing the final legislative proposal and urges the Commission to consider our demand that medical devices are safe, patients are involved, and MDR and HTAR align to deliver timely, reliable access to medical devices across Europe.
Thank you to the EFA community members Federación Española de Asociaciones de pacientes alérgicos y con Enfermedades Respiratorias, FENAER (Spain) and Longfonds (The Netherlads) whose contributions shaped this response.
Read EFA’s full response to the consultation here: https://lnkd.in/ejTSPMfv