Date lodged: 31 March 2017
To ask the Scottish Government, further to the statement by the Cabinet Secretary for Health and Sport on 30 March 2017 (Official Report, c. 57), what its response is to concerns that the final mesh report does not make clear that the EU classifies mesh as "high-risk".
Answered by: Shona Robison 28 April 2017
The Independent Review’s Final Report made clear that, at the time of writing, it was anticipated that the new EU Medical Device Regulations would include a change to the classification of surgical mesh devices intended for long-term or permanent use.
It is now confirmed that the new EU Regulations, subject to their formal adoption, will up-classify surgical meshes to Class III. The new Regulations can be viewed here: http://data.consilium.europa.eu/doc/document/ST-10728-2016-REV-4/EN/pdf.