ESC applauds EC medical device regulation proposals

The European Society of Cardiology (ESC) said that the European Commission's proposal for a new regulation to govern the evaluation and approval of medical devices in Europe is an important step toward improving patient safety.

In a position paper coordinated by the ESC Task Force on Medical Devices, the ESC said it particularly welcomes the proposal's to unify the directives into a single regulation, increased coordination between the national competent authorities, and the enhanced quality control of Notified Bodies. The European Commission proposal is currently being considered by the European Parliament and the Council of the European Union.

The ESC authors also 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;
  • The establishment of independent postmarket surveillance

Inclusion of the five suggested amendments would help maintain access for patients to new devices, while also ensuring a high level of protection for public health, the ESC said.

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