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June MedTech Trade Association Forum meeting

By June 24, 2022No Comments

The agenda covered various updates across Government, lead by the Department of Health and Social Care. The new Northern Ireland Bill was discussed, and what this could mean for products between Northern Ireland and Great Britain. The Bill still needs to pass though parliament before it enters into force, but it could introduce a dual regulatory route for products allowing manufacturers to choose the appropriate regulatory regime for them.

The meeting also provided confirmation that the MHRA response to the UKCA consultation is expected ‘imminently’. BIVDA will let members know as soon as this is published.

Regarding UK Approved Bodies, there are currently 3 designated with a further 5 going through the designation process. Hopefully, this will decrease the current pressure in the space.

BIVDA was requested to inform members about the ongoing product supply shortage concerns, and to please keep this in mind in relation to your stock levels to ensure continued supply to healthcare.

Finally, some surveys are underway which we encourage members to respond to:

  1. First principles review on the UK’s global regime for Safety & Security (S&S) requirements
  2. 2025 Border Strategy border survey

The next meeting is scheduled for 19 July.

Natalie Creaney