13.11.12
Consultation on medical device regulations overhaul
The European Commission’s proposals to revise the 20-year-old regulatory framework on medical devices have been put out to consultation by the MHRA this week.
The regulations cover everything from breast and hip implants to hospital equipment like dialysis machines.
The European proposals are aimed at responding to technological and scientific progress, and to harmonise the way different directives have been implemented by member states.
The MHRA says the proposals “improve traceability, tighten up controls on the bodies which assess the safety of devices before they are placed on the market (termed ‘notified bodies’), and set out clearer, but proportionate, requirements for clinical evidence”.
Over the next ten weeks, it wants healthcare professionals and the public to give their views on whether the proposals go far enough in promoting the safety of medical devices and ensuring public confidence in the regulatory system, in improving the organisations which assess the safety of medical devices, and in ensuring transparency and ensure better collaboration between national regulators.
John Wilkinson, the MHRA’s director of medical devices, said: “It’s vital that the European system of regulation is strengthened so that people are protected against unsafe medical devices.
“We have been pressing the European Commission to strengthen regulation in Europe for the last four years. We believe that there should be tighter controls on notified bodies, better post-market surveillance of medical devices and more collaboration between national regulators. Now it’s important that doctors, nurses and members of the public have their say in shaping medical device regulation.”
Visit the consultation page before 21 January 2013 or find out more on the MHRA website.
Tell us what you think – have your say below or email [email protected]