Since Brexit, Great Britain has its own rules for medical devices, managed by the Medicines and Healthcare products Regulatory Agency (MHRA). UK distributors at MEDICA should check that their suppliers can meet them.
This is a short overview, not regulatory advice. The UK rules have been changing, so check current guidance on the MHRA website.
UKCA and CE marking
The UK introduced its own UKCA mark. However, the UK has extended the period in which CE-marked devices can still be sold in Great Britain. Northern Ireland follows EU rules. Check the current deadlines before you decide which marking you need.
Registration with the MHRA
Medical devices placed on the market in Great Britain must be registered with the MHRA. Manufacturers outside the UK need a UK Responsible Person (UKRP) to do this for them.
What to ask suppliers
- Do your products carry CE marking under the EU MDR?
- Do you have a UK Responsible Person?
- Are your devices registered with the MHRA?
- Can you label for the UK market?
Your role as a UK distributor
Check that products are correctly marked and registered, keep records of what you sell and report problems to the MHRA.
UK buyers at Tata Surgical
Visit Hall 10, Stand C32 to discuss documents and labelling for the UK market.
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