MDR Frequently Asked Questions

What medical device technical experts have to say

With the new Medical Device Regulation (EU) 2017/745 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 wish to have an assessment against the new MDR will need to apply to a Notified Body for assessment.

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.