What medical device technical experts have to say.
With the new In Vitro Diagnostic Device Regulation (EU) 2017/746 published in May 2017, regulatory affairs professionals and medical device manufacturers are now seeking guidance on how to implement the new requirements within their organisations.
It is worth mentioning that as there is no ‘grandfathering’ for existing products, all manufacturers will need to review their existing products against the requirements of the regulation. Manufacturers that have not been assessed under the current Directives will need to apply to a Notified Body for assessment, whilst those that have already been assessed by a Notified Body will need to submit an application to have both their existing certified and current self-declare products assessed under the regulations.
LRQA’s medical device technical experts answer some frequently asked questions to provide you with clarification on how to implement the requirements introduced by the new regulation and advise you on the steps you can take in order to prepare.