The MHRA presented guidance on the situation of medical devices and IVD’s after January 1st, 2021. What are the implications of Brexit:
- The UK will introduce a new route to market – UKCA – available from January 1st, 2021.
Guidance for the MHRA Brexit by Sue Spencer
From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering:
- 4 months for Class IIIs and Class IIb implantables, and all active implantable medical devices + Annex II List A IVDs
- 8 months for other Class IIb and all Class IIa devices + IVD List B, Self-test IVDs
- 12 months for Class I devices + General IVDs.
The registration with the MHRA can only be submitted by UK manufacturers or UK Responsible Person.
- UK responsible person needs to have a place of business in the UK
- a product list including the products that should be registered as well as the referring GMDN code is required
- If applicable, a copy of the CE certificate should be provided
- documentary evidence supporting the position of the UK Responsible Person is required (letter of designation, signed contract) including company name and address of the manufacturer not located in the UK before June 2023
- One application consists of products having the same GMDN code
- Manufacturers not established in the UK who need to designate a UK Responsible Person do not need to change the labelling of their products placed on the UK market
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