UK RepMed is an independent Responsible Person company and EU Authorised Representative.

Under new Brexit regulations put in place by the MHRA all Medical Device Manufacturers must have a Responsible Person by 1st January 2022.

A Responsible Person is a company based in the UK who acts on behalf of a Manufacturer, who is not based in the UK, to register their products on the UK market and informs the Manufacturer about complaints reports and incidents raised by the MHRA.

UK RepMed can act as your responsible person, we can ensure that you meet all your legal obligations under UK regulations that apply to your products, minimising risk. We can respond with knowledge to queries from the authorities or other third-parties when they arise. We can keep you up-to-date on regulatory changes to ensure your products remain compliant.

Our experienced consultants will review your Technical File, register your medical device, as required, and respond to any questions or concerns from the Competent Authorities and or the MHRA.

You will have secure access to all your documentation and regulatory information, including technical files, labelling information and symbols, language requirements, directives, and guidelines

Our vast expertise with European regulations and UK regulations, facilitates a smooth and efficient registration process.

We will send frequent updates to all our represented clients with important regulatory updates focused on the UK