Service
UK Responsible Person Services
Manufacturers based outside the United Kingdom must appoint a UK Responsible Person (UKRP) before placing medical devices on the Great Britain market. The UK Responsible Person acts on behalf of the manufacturer in relation to specified regulatory obligations and serves as an important point of contact with the Medicines and Healthcare products Regulatory Agency (MHRA).
MG Regulatory provides dedicated UK Responsible Person services to manufacturers seeking access to the Great Britain market. Our team supports manufacturers in meeting regulatory requirements while maintaining an efficient and compliant route to market.
As part of our service, we review regulatory documentation, support device registration activities, and assist manufacturers in maintaining compliance with applicable UK medical device legislation. We also provide ongoing support relating to regulatory changes, post-market obligations, vigilance activities, and regulatory communications.
With UK regulatory requirements continuing to evolve, manufacturers increasingly require a UKRP that offers not only representation but also practical regulatory guidance. Our objective is to help manufacturers maintain compliance, minimise regulatory risk, and preserve uninterrupted access to the UK market.
By partnering with MG Regulatory, manufacturers gain access to experienced regulatory professionals who understand both the regulatory framework and the practical challenges associated with commercialising medical devices in Great Britain.
Testimonials
FAQ
Straight Answers to Common Questions
We assist manufacturers with regulatory strategy, documentation preparation, and compliance to ensure devices meet EU MDR requirements.
Yes, we provide support for FDA regulatory pathways including 510(k), De Novo, and PMA submissions.
Yes, MG Regulatory can act as your UKRP if your company is not based in the United Kingdom.
Yes, we offer customized training programs covering EU, UK, and US medical device regulatory frameworks.
Have More Questions?
Contact Us for more.
At MG Regulatory, we provide expert regulatory guidance for medical device manufacturers seeking access to the UK, EU, and US markets.
MG Regulatory’s project plan mapped out every step of our regulatory submission in minute detail, which kept us on track for a smooth CE mark application. When unexpected questions came back from our notified body, the team responded quickly, often within 24 hours, without compromising on quality.