Motions, questions and answers

The European Union is presently developing EUDAMED. This system will assist European authorities to support market surveillance on medical devices through information exchange, and help to ensure that medical devices that are placed on the market and put into service comply with all of the European Union's requirements.
In addition, the Scottish Government is working with the Department of Health and devolved administrations in order to establish patient-level registries in certain specific areas, including breast and cosmetic implants, as well as stress urinary incontinence and pelvic organ prolapse procedures. With respect to the latter, an outline of an interim registry has been agreed upon and will be revealed by the Healthcare Quality Improvement Partnership next year. It is expected to become operational next spring, and officials will be considering information governance aspects in order to ensure that NHSScotland can fully participate. A bespoke registry will continue to be developed after implementation of the interim solution, with delivery expected in around two years. Both the interim and bespoke registries will record all stress urinary incontinence and pelvic organ prolapse procedures, not just those that involve mesh repair. Further, they will record patient reported outcomes in addition to clinician reports.