Our recommendations on medical devices for the Council

On 17 December we sent a letter to permanent representations of EU Member States with recommendations on the proposal for a regulation on Medical Devices. These recommendations reiterate our position and support key changes adopted by the European Parliament in October 2013. Following the European Parliament vote, the text is now under discussion within the Council. The Greek Presidency, presenting their priorities in the field of health for the next six months, indicated that they aim to see “significant progress” on this issue.

The Minister for Health, M. Georgiadis stated it is an issue of high political importance and that “these proposals will build trust between consumers/users, health professionals and economic operators and will provide a legislative framework for the manufacture and placing on the market of medical devices, while ensuring a high level of health protection. (Link)

EPF strongly supports this statement as well as actions by the Presidency and the Council to ensure the Regulation is finalised and adopted without delay. Indeed the review of the current medical devices legislative framework, which dates back from the 90s, holds very important stakes for patients in the EU.

As we highlighted in our recommendations, we call on the Council to continue improving patient safety, quality of care, and patients’ well-being as priorities within the new Regulation.

In 2014 EPF will follow up on our work to ensure the future Regulation on Medical Devices results in more transparency towards the public, safer medical devices, and strong representation of the patients’ perspective in the development and use of essential medical technologies.

For more information, please contact Laurène Souchet, Policy Officer, at laurene.souchet@eu-patient.eu.