“As the protection of patient safety is a paramount objective, the European Parliament has today taken a substantial leap forward to prevent the serious consequences caused by the use of medical devices, such as the Poly Implant Prothèse (PIP) breast implant which caused a scandal in 2011 (2),” said Peggy Maguire, President of EPHA.

EPHA’s briefing on medical devices (3) points out the dramatic increase in faulty medical devices over the last decade, which entered the market due to serious loopholes in the regulatory framework.

The healthcare of an ageing European society increasingly relies on medical devices, and integration of eHealth and mobile health (mHealth) technologies makes them ever more sophisticated, thereby providing patients with a greater degree of independence. The new regulations tighten up requirements so that manufacturers develop better designed devices that can reach the end of their expected life time without causing hazards for individuals.

While the majority of the discussions about this dossier revolved around the exact nature of the so-called pre–market authorisation process, Rapporteur Dagmar Roth-Behrendt (S&D, Germany) advocated for the introduction of a centralised process for high risk devices. Last year the lead Committee (ENVI) in the European Parliament adopted a compromise solution involving special notified bodies designated by the European Medicines Agency.

The Parliament’s vote endorses a stricter process involving pre-market assessments, together with post-market monitoring and vigilance. It is hoped that the new regulations will be robust enough to meet requirements that the previous legislation lacked.

EPHA strongly believes (4) that increased transparency and traceability are crucial at all stages of the approval process for new medical and in vitro diagnostic medical devices. "Access to clinical data will allow healthcare professionals to take better informed medical decisions about which devices to use. Using more transparent processes will help restore patient confidence, supporting the European databank that helps patients to be informed about medical devices’ functions, risks and benefits," underlined Ms Maguire.

Yesterday’s vote means that following the European Parliament elections in May, the Parliament can conclude the legislative process under its next mandate on condition that the Council will be able to settle its position. People-centric, high quality health services and innovation, as well as universal access as drivers for sustainable development are also key demands of EPHA’s Election Manifesto (5).

- Notes to editors

(1) Revision of the medical device directives. Ongoing revision - Proposals of the European Commission

(2) Q&A: PIP breast implants health scare, BBC News Health, 10 December 2013

(3) EPHA Briefing on Medical Devices Directive, first published in August 2012

(4) EPHA Position on Medical Devices, updated in August 2013

(5) In its Manifesto for the European Parliament elections, the European Public Health Alliance calls on political parties and individual Members of the European Parliament (MEP) candidates to ensure that health and well-being in Europe are ranked as high as they are valued.

- Contact information

Javier Delgado Rivera, EPHA Communications Coordinator at j.delgado-rivera@epha.org or 32 (0) 2 233 38 876

Last modified on April 19 2014.