On 21 March, the European Federation of Allergy and Airways Diseases Patients’ Associations (EFA) submitted its response to the European Commission’s call for evidence on the evaluation of the Medical Device Regulation (MDR). Based on expert written input and a members workshop, EFA gathered evidence to inform about shortcomings of the current medical devices legislation and recommendations to improve the framework while pursuing allergy and chronic respiratory diseases patient’ safety. We thank participants from Bosnia and Herzegovina, Italy, the Netherlands, and the United Kingdom for their contributions.
Why the EU MDR evaluation matters
The MDR impacts many devices allergy, asthma and chronic obstructive pulmonary disease (COPD) patients rely on – such as spirometers, oxygen concentrators and ventilators – as well as combination products such as inhalers, nasal sprays and injectors. While the MDR, adopted in 2017, has strengthened patient safety, its implementation has posed challenges, potentially affecting access to essential medical devices.
EFA emphasises that any MDR revisions to simplify the regulatory process of development, assessment, authorization and surveillance, must not weaken safety standards. Our recommendations aim to enhance patient protection while improving regulatory clarity and ensuring accessibility.
Key EFA recommendations on medical devices
1. Strengthening patient education. Patients with allergy, asthma and COPD require continuous education on using medical devices correctly and safely, especially if there are combined with medicines. Allergy patients, in particular, need to receive detailed information of allergens present in medical device components, such as latex.
2. Improving inhaler and nasal spray safety. Patients struggle to identify when inhalers are empty or faulty, and these devices do not track total corticosteroid doses, increasing the risk of overdosing. EFA identified that their usability and safety can thus be improved.
3. Increasing patient involvement in medical device regulatory work. To address patient needs, EFA calls for patient inclusion in key MDR bodies such as ethics committees, the Medical Device Coordination Group (MDCG), and expert panels.
4. Enhancing safety reporting. Patients often lack clear pathways to report safety concerns. EFA urges improved accessibility to reporting mechanisms and a stronger role for patient organisations in compiling safety data.
5. Clarifying legislation for combination products. Combined medical products, like inhalers, face fragmented regulatory pathways, leading to risk oversight. EFA recommends recognising them as a distinct category with a dedicated and streamlined regulatory framework.
6. Establishing an EU centralised medical device regulatory dody. Unlike medicines, medical devices lack a centralised EU regulatory agency. A dedicated body could streamline approval processes and ensure equitable device access.
7. Promoting innovation and digitalisation. Technology can improve patient self-management, particularly for those with chronic diseases. MDR should support innovation while maintaining strict safety standards.
8. Ensuring access to spare parts. Chronic disease patients rely on devices long-term, yet spare parts are often unavailable, forcing full replacements. Regulations should facilitate access to non-critical spare parts to reduce costs and waste.
Next Steps
EFA will continue to monitor the MDR review and advocate for patient safety. The full EFA response is available here. Stay connected for further updates on our advocacy efforts.