In September 2012, the European Commission published what it thinks the new legislation on medical devices should look like. The countries in the European Union and the European Parliament are now negotiating and agreeing the final legislation.
The MHRA held a ten-week public consultation to seek the views of healthcare professionals, patients, industry, academics, and the interested public on the draft new European legislation on medical devices. Our aim was to understand the views of those interested in and impacted by the proposed new legislation. The deadline to submit evidence was 21 January 2013.
We were really pleased to get over 100 responses from healthcare professionals, industry, individuals, and charities. We have used this evidence to challenge and strengthen the Government's policy position. In April 2013, we published an analysis of the evidence which we received from stakeholders. We have also highlighted how the MHRA will take account of this evidence in the Government’s negotiating position.
You can read the public consultation and our analysis of the evidence submitted using the links below.