Press release - 1st November 2012
BSI, the business standards company and EU Notified Body for medical devices, welcomes The Science and Technology Select Committee’s report on the ‘Regulation of Medical Implants’.
The report recognises that the EU medical device regulation is undergoing a major review; however, it states quite clearly that there is no need for a fundamental change to the current system.
As patient safety is paramount, we endorse the report’s recommendations for improved transparency and communication between Notified Bodies and Competent Authorities throughout the EU and medical device manufacturers. In addition, BSI is in accord with the discussion surrounding the appropriate use of equivalence versus clinical investigation.
BSI supports the specific actions aimed at ensuring that all Notified Bodies have the appropriate level of expertise and competence and improved oversight to ensure this is the case. This will enable Notified Bodies to meet their primary objective of effectively assessing product performance and safety in the interest of protecting patients across Europe.
The Science and Technology Report should support both the UK government and the EU in improving Medical Device regulation and we welcome its publication.