Medical Devices: Proposal for New Regulation


Photo: European flags

The European Society of Cardiology makes five suggestions to improve European legislation of medical devices; © Van Ostaeyen

In a position paper, the European Society of Cardiology (ESC) welcomes the European Commission’s (EC’s) proposals for a new regulation to govern the evaluation and approval of medical devices as an important step towards improving patient safety.

The position paper, coordinated by the ESC Task Force on Medical Devices, comes as the European Commission proposal is being considered by The European Parliament and The Council of the European Union. The ESC authors have outlined five further suggestions that they feel would make the legislation stronger: a requirement to establish the clinical efficacy of certain new high-risk devices; greater transparency; a formalized European system for obtaining expert scientific and medical advice; specialization of Notified Bodies evaluating high-risk medical devices; and the establishment of independent post-market surveillance.

“To protect patients it is important to achieve a balance between over-regulation that thwarts innovation and the release of devices that have not been properly evaluated,” said ESC President Professor Panos Vardas, who co-chairs the ESC Task Force on Medical Devices. “We feel that cardiologists are particularly well placed to play a greater role in device regulation. We are among the main users of permanently implanted medical devices for our patients, and have a good appreciation of what risks are considered acceptable and how devices should be evaluated from a clinical perspective.”

In its position paper, the ESC particularly welcomes the unification of the directives into a single regulation, increased coordination between the national competent authorities, and the enhanced quality control of Notified Bodies. Inclusion of the five amendments, the ESC felt, would help to maintain access for patients to new devices while also ensuring a high level of protection of public health. “Overall for doctors to be able to practice good evidence-based medicine when using devices, we feel that more clinical trials need to be undertaken to establish efficacy, and that far more information needs to be made available in the public domain,” said Professor Alan Fraser, co-chair of the ESC Task Force on Medical Devices.

The ESC has proposed that the concept of conditional approval should be included in the Regulation, where competent authorities can specify that continued access to the market for a particular device is made dependent on the manufacturer collecting further evidence of its clinical efficacy. This strengthened post-market evaluation would complement early access to the market for new medical devices that meet a clinical need. Cardiologists and academic engineers work with manufacturers to develop and evaluate new devices, and the ESC considers that such collaborations are essential. “Conditional approval would be one way to support innovation without burdensome over-regulation, while ensuring the safety of patients,” said Professor Fraser.; Source: European Society of Cardiology