Lack of patient involvement in the Council position on medical devices

On 5th October, the Council formally adopted their position on medical devices and in vitro diagnostics medical devices, which were partially released in June. In the review of this legislation a key stake from the patients’ perspective was to ensure more patient involvement in the governance of medical devices, however, this still remains scarce.

The Council proposes a very limited role for patients who could be invited on ad hoc basis as observers in sub groups of the Medical Device Coordination Group. Similarly the European Commission’s first proposal contained only limited provisions for involvement. 

Why should the EU Institutions embed patient involvement in the medical devices legislation?

Patients’ role in this process is crucial, as medical devices canmake a real contribution to their health, life expectancy, and quality of life. Patients, as managers of their condition, have a unique expertise and can contribute to improving the safety and quality of the medical device they use or are in contact with for the management of their conditions.  

Patient involvement is also important in restoring trust and improving transparency. A key step forward in the recent debates on medical devices is the commitment of the three EU institutions to improve transparency and provide better information to patients. Yet, with no clear commitment to user and patient involvement, who will ensure that the information shared is relevant to patients? 

Patient involvement is feasible: a look at the EU medicines governance

In the area of medicines, patients are recognised as experts and are participating in many aspects of access, innovation and safety. Thanks to the European Medicines Agency (EMA) and the establishment of a Patients’ and Consumers’ Working Party, we ensure that the patients’ perspective is included in the medicines’ research and development process. In contrast, there is no such structure for the implementation of similar provisions in the upcoming Medical Devices Regulation.

The EU is also committed to patient centred healthcare. In 2006 the Council adopted the Council Conclusions on common values and principles in European Union Health Systems declaring that “all EU healthcare systems aim to be patient centred” and committing to patient involvement as a common operating principle of all EU healthcare systems.

It there still time to act for a change of mind-set?

The new regulation on medical devices raises the question whether the EU institutions will hold on to their commitment to patient participation or if we will have to wait for another decade for patient centred healthcare to also apply to medical devices? As the Trilogue between the three EU institutions has recently started to come to a final compromise on medical devices, the end of 2015 is the last chance for patient organisations to share their views.

EPF are producing recommendations to the Trilogue over the next few weeks, building on our previous input within the legislative process.

Contact: Laurène Souchet, EPF Policy Officer,