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Medicines and Healthcare products Regulatory Agency (MHRA), News & Updates

MHRA seeks views on the regulation of medical devices

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 websiteYou can email your views to: medical.devices@mhra.gsi.gov.uk

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:

Faulty medical implants investigation: Regulators’ trail of deception has been exposed, says chairman (Telegraph)

Faulty medical implants investigation: Patients at risk from flaws in medical device rules, admit EU chiefs (Telegraph)

Faulty medical implants investigation: Patients failed by poor implant regulation, say surgeons (Telegraph)

How a fake hip showed up failings in European device regulation (BMJ)

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Discussion

3 thoughts on “MHRA seeks views on the regulation of medical devices

  1. Thank You for all your help and support!
    David & Teresa of TVTNO.org it wouldn’t allow me to use david@tvtno.org as my email for some reason but no biggie! Keep up the good work my friend love and blessings from here in the USA

    Posted by David & Teresa david@tvtno.org | November 13, 2012, 11:32 pm
  2. I have dealt with The Medicine Health Regulator for many years and they are just white washing over the statistics in England regardless of what the figures are for Northern Ireland Wales and Scotland. Their recent review through York University was a load of nonsense. They are still not listening to the patients who are suffering and need to be taken to task.

    Posted by Teresa Hughes | December 20, 2012, 11:14 pm
  3. I completely agree. The MHRA would not allow patient groups to be represented at their meetings on mesh devices earlier in the year but had separate meetings with the founders of both support groups which was, as I suspected then, just a way of paying lip service to their concerns whilst being seen to be ‘listening’.

    The MHRA have not dealt with this problem adequately or intelligently. Having seen the recent money-wasting York Report, mesh sufferers are now in no doubt that this is a betrayal by the MHRA who feel they have exonerated themselves with this report and are now immune from any criticism.

    Posted by tvtinfo | December 21, 2012, 8:46 am

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