A flavour of EPF’s position on the Medical Devices Proposal

Susanna Palkonen, EPF vice president, gave a foretaste of our position on the Commission’s proposal on Medical Devices at the MedTech Forum, on 11 October in Brussels. She highlighted that, in EPF’s perspective, the future regulation should aim at achieving a high level of patient safety and quality of care together with improved transparency and information for patients.Medical devices are of crucial, and often vital, importance for patients with chronic diseases. They can provide a major contribution to life expectancy and quality of life of patients. They can also provide innovative solutions to face the challenge of ageing, the rising prevalence of chronic diseases, and shortage of healthcare professionals.

“During the consultation regarding the proposal EPF has been calling for a robust safety framework and some provisions are in favor of our calls”, said our Vice President. EPF embraces the provisions in the proposal that will lead to a better supervision of assessment bodies by national authorities, and a better evaluation of manufacturers’ and product safety thanks to, for instance, the traceability of devices.  EPF believes that encouraging direct reporting of incidents and adverse events is also essential to enhance patients’ safety. The proposal foresees that patients will be able to report directly to their national authority. In order to ensure reporting is adequately encouraged and that mechanisms are patient friendly, patient and consumer organisations should be involved in the implementation of this measure. “This needs to be a mandatory requirement in the legislation”, stated Ms. Palkonen.

The proposal for a regulation also addresses some of the key concerns the patient community had raised regarding transparency and information to patients. More transparency towards the public is necessary to empower patients and ensure public trust and confidence in the safety of medical devices. Besides information and health literacy is key for patients to become effective co-managers of their diseases. It also empowers them to contribute actively to their healthcare, to patient safety, and to the development of new innovative solutions.

One essential point which we believe is missing from the proposal is a clear framework for the meaningful involvement of patient representatives on issues related to medical devices. Patients have unique expertise resulting from living with a specific condition and their experience of navigating the healthcare system and services. EPF calls to involve them in a structured way by having a direct patient perspective in key decision making bodies on medical devices.

EPF will develop an official position in the next few weeks, after the consultation of our membership. We are committed to participate constructively in the debate on the review of the regulatory framework for medical devices, and to bring constructive recommendations in order to ensure that patients have equitable access to innovative, safe and high-quality medical devices throughout the European Union.