The Medicines and Healthcare products Regulatory Agency (MHRA) issued a press release on 12th November urging healthcare professionals and the public to give their views on new draft European laws for the regulation of medical devices.
The EU proposals are intended to ‘increase transparency, simplification and cooperation between Member States’. It is also hoped that they will improve traceability, tighten up controls on the Notified Bodies which assess the safety of devices prior to being placed on the market, and set out ‘clearer, but proportionate, requirements for clinical evidence’.
The MHRA claims to have been “pressing the European Commission to strengthen the current European system of regulation for four years”. They say that they have been pushing for tighter controls on notified bodies, better post-market surveillance of medical devices and more collaboration between national regulators.
During the ten-week consultation they are hoping that doctors, nurses and the general public will give their views on the new draft legislation. They are asking whether people regard the legislation as adequate 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
The consultation takes place from 12th November 2012 to 21st January 2013. People can take part in the consultation by visiting the consultation page on the MHRA website. You can email your views to: firstname.lastname@example.org
Read MHRA press release: Press release: MHRA seeks views on the regulation of medical devices
For more information on the EU proposals click here: http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm
View the UK Parliamentary Select Committee’s Report: Science and Technology Committee Fifth Report on the Regulation of Medical Implants in the EU and UK published 17th October 2012
Read recent articles on the failings of current device regulation in Europe: