Service
Authorised Representative Services
Manufacturers established outside the European Union are required under the EU Medical Device Regulation (EU MDR 2017/745) to appoint an Authorised Representative before placing devices on the European market.
The Authorised Representative performs an important regulatory function, acting as the manufacturer’s designated point of contact within the European Union and supporting compliance with applicable regulatory obligations throughout the device lifecycle.
MG Regulatory provides independent Authorised Representative services to manufacturers seeking access to the European market. Our experienced regulatory team conducts detailed reviews of relevant documentation and works collaboratively with manufacturers to support continued compliance with EU MDR requirements.
Our approach extends beyond fulfilling statutory obligations. We seek to establish a proactive regulatory partnership that helps manufacturers identify compliance gaps, strengthen regulatory systems, and maintain ongoing conformity as regulatory expectations evolve.
In addition to carrying out the responsibilities associated with the Authorised Representative role, we support manufacturers with post-market activities, vigilance obligations, regulatory communications, and broader compliance matters that may arise throughout the lifecycle of the device.
Through a combination of regulatory expertise, responsiveness, and practical industry experience, MG Regulatory provides manufacturers with a trusted European regulatory presence and a reliable partner for long-term market access.
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.
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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.