About UK RepMed

UK RepMed specializes in serving as a UK Responsible Person for Medical Device Manufacturers, also known as an Authorised Representative or UK Rep. This role has become a mandatory requirement set forth by the MHRA (UK Competent Health Authority)in the wake of Brexit. All Medical Device manufacturers based outside the UK, aiming to continue exporting to the UK market, must register their Medical Devices with the MHRA through a UK Responsible Person. UkRepMed also specialise in the UK Responsible Service for Cosmetics, Electronics and Food Supplements

UK RepMed Limited, a UK-based company, excels in addressing regulatory registration needs within the international medical component industry for manufacturers located outside the UK.

If you are an overseas manufacturer selling into the UK market, appointing UK RepMed Limited as your UK Responsible Person offers numerous advantages:

1. Legal Compliance: We ensure that you meet all your legal obligations under UK regulations relevant to your products, significantly reducing your compliance risks.

2. Expert Support: Our team is equipped with comprehensive knowledge to promptly address queries from authorities or third-parties as they arise.

3. Regulatory Updates: Stay informed about crucial regulatory changes to ensure your products remain compliant in the evolving landscape post-Brexit.

Our seasoned consultants will meticulously review your Technical File, perform essential registrations for your medical devices, and promptly respond to inquiries from Competent Authorities and the MHRA.

Moreover, we provide secure access to all your essential documentation and regulatory information, including technical files, labelling requirements, language specifications, directives, and guidelines.

Leveraging our extensive expertise in European regulations, we streamline the registration process, making it both seamless and efficient.

Rest assured, we keep our represented clients regularly updated with vital regulatory changes, particularly those of the UK market.

An ever-increasing importance for Medical device Manufacturers is Biocompatibility testing. This is becoming essential for those manufacturers going the new EU MDR. We have a partnership With a University Pharmaceutical centre that undertakes the testing for Medical Devices. Find out more here

At UK RepMed, we’re committed to simplifying your compliance journey and ensuring your products continue to thrive in the UK market.