UKRepMed
UK Responsible Person,
Biocompatibilty Testing
UK RepMed
specialises in regulatory services for Medical devices, Electronics, Cosmetics and Food Supplements.We can act as a UK Responsible Person, EU Authorised Representative and Consult on other regulatory requirements
We have experts with the relevant experience:
Notified Bodies
MHRA
Medical Devices
MHRA Contact
NHS/UK Health Provider
Manufacturing Experience
Medical Devices
Technical File Expertise
Registration Expertise
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UK Rep Med, your UK Responsible Person
From the 1st January 2022 all Manufacturers based outside the UK need to appoint a UK Responsible Person (UKRep/UKRP) who is responisble for:
- Checking the manufacturer has a valid CE, ISO, and DOC (CE Class dependent).
- Submitting and managing the registeration of devices with the UK Competent Health Authority (MHRA).
- Responisble for the contact between the MHRA and the manufacturer when needed. You must have a UK Responsible Person to to import medical devices into the UK.
- This is a requirement under the new UK MDR set out by the MHRA.
UK Rep Med Limited
Unit D, Crondall Place. Coxbridge Business Park , Alton Road, Farnham, GU10 5EH, UK.
Email: sales@ukrepmed.com
Phone: +44 (0) 1252 912933
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