OSA MDR Regulation and Legislation Meeting – Thursday 3 June

May 12, 2021

On Thursday 3 June there will be a special meeting taking place for OSA  members to discuss concerns about post-Brexit MDR regulation. This is a thorny subject with potentially huge implications for our membership.  Following members’ feedback, the OSA called this meeting so that concerns, comments and questions on this issue can be gathered and put to the MHRA requesting the clearest possible guidance.

Ann Blackmore, OSA Consultant, is chairing this meeting: ‘post-Brexit was always going to be a difficult time as manufacturers, importers and exporters got used to new rules and regulations. But it is doubly difficult for medical device manufacturers because the change has coincided with the introduction of new and different rules in the EU. That is why it is so important that the MHRA provides strong support and clear guidance.’ states Ann.

OSA Vice Chair Andy Hepworth adds ‘To call this a thorny subject probably understates the complexity of this area. The great news is that the OSA have again captured the thinking of Ann Blackmore to support our membership’.

There is now a ‘UK Regulations’ page has been added to the OSA website to help suppliers with regards to MDR and the future regulatory framework – please go to www.osa-uk.co.uk for more information. If you are an OSA member wishing to attend the 3 June meeting, please contact [email protected].