GovWire

The measure aims to strengthen requirements on medical device manufacturers to undertake post[1]market surveillance (PMS) practices.

The Impact Assessments assessment of direct impacts on business is satisfactory, based upon business survey evidence and detailed modelling. The consideration of impacts on small and microbusinesses is sufficient, although could be strengthened. There are areas where the wider analysis could be improved, particularly on consideration of wider impacts.

The measure will affect the medical technology sector, including commercial suppliers, through strengthening requirements on medical device manufacturers to undertake PMS practices. The proposal applies to Great Britain (GB) only; the IA states that under the terms of the Windsor Framework the rules for placing medical devices on the Northern Ireland market differ from those applicable to GB. Compared to the do nothing baseline, manufacturers who supply medical devices are estimated to incur a one-off setup cost of 16.2 million and annual PMS maintenance costs rising from 23.5 million to 45.2 million over the ten-year appraisal period. These are direct costs and reflected in an EANDCB figure of 35.6 million. There are no direct benefits to business. The ten-year net present value (NPV) figure of -277.8 million additionally reflects an estimated health benefit from reduced medical device incidents of 3.3 million per year.