Date lodged: 27 November 2018
To ask the Scottish Government what its response is to the report by the International Consortium of Investigative Journalists on the use of medical implants, and what implications it has for Scotland.
Answered by: Jeane Freeman 21 December 2018
On 31 October, both the Chief Medical Officer and I wrote to the MHRA to express concerns about how medical devices are regulated in the UK. We questioned the degree to which the present system of regulation is fit for purpose, and the level of scrutiny given to evidence prior to the approval of a medical device.
Although some assurances were received in the agency’s response, the Chief Medical Officer has written again to the MHRA. Aside from asking the MHRA to set out the actions it has taken specifically in relation to transvaginal mesh, the Chief Medical Officer also outlined a number of more general concerns, including in relation to the governance of notified bodies, the MHRA’s relationship with industry, and public confidence in the agency and the regulatory system.
Details are provided in a Scottish Government news release of 27 November: www.gov.scot/news/regulation-of-mesh-devices .