MHRA seeks views on the regulation of medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has urged healthcare professionals and the public to give their views on new draft European laws for the regulation of medical devices such as breast and hip implants and hospital equipment, such as dialysis machines.

Medical device regulation continues to be a hot topic of debate following PIP breast implants and the recent safety concerns involving metal-on-metal hips.

The MHRA has been pressing the European Commission to strengthen the current European system of regulation for four years and has now launched a ten-week consultation so that healthcare professionals and the public can give their views on whether new draft legislation from the European Commission goes far enough in the following areas:

• Promoting the safety of medical devices and ensuring public confidence in the regulatory system.
• Improving the organisations (notified bodies) which assess the safety of medical devices.
• Ensuring transparency and ensure better collaboration between national regulators.