Medical Device Regulation and a Hard Brexit

The U.K. Government released information today on Medical Device Regulation and a Hard Brexit.  Here is the link to the relevant page:  https://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal.

As noted before, the U.K. and BSI in particular are trying to keep a hard Brexit from negatively impacting public health and welfare.  To this end, participation in EU standards activities and maintaining regulatory consistency short term are top priorities.  I know many of our Document Center Inc. customers and other medical device manufacturers have been concerned.  You will all appreciate this official information which provides the beginning of clarity on this worse-case scenario.

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Claudia Bach

Claudia Bach is the President of Document Center Inc. and a world-wide recognized expert on Standards and Standards Distribution. You can connect with her on Google+

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