MHRA Medical Device Registration (UK)
Ensure your medical or IVD device is fully compliant with the UK’s MHRA regulations. We offer expert guidance on every step of the MHRA registration process from documentation to submission.
Frequently Asked Questions (FAQs)
Is CE marking still accepted in the UK?
Only in Northern Ireland or during limited transition periods in Great Britain. UKCA is now required in GB.
How long does MHRA registration take?
Normally 5–10 working days once the documents and fees are submitted.
Can one UKRP represent multiple devices?
Yes, if authorized by the manufacturer for each.
Do custom-made devices need registration?
Yes, if they are to be placed on the market.
Is MHRA registration needed if the product is already CE-marked?
Yes, CE-mark alone does not suffice in Great Britain post-Brexit.
