Service
Regulatory Importer Support
The role of an importer carries specific regulatory obligations under both EU and UK medical device legislation. Organisations sourcing medical devices from outside the relevant jurisdiction may assume importer responsibilities regardless of whether regulatory compliance forms part of their core business activities.
Importers are required to verify that devices meet applicable regulatory requirements before being placed on the market. These obligations include reviewing compliance documentation, maintaining traceability, ensuring appropriate labelling, and supporting post-market activities where required.
MG Regulatory provides specialist support to importers, distributors, wholesalers, resellers, and e-commerce businesses seeking to establish and maintain compliant importer operations.
Our services are designed to help organisations understand their regulatory responsibilities, implement proportionate compliance processes, and mitigate the risks associated with placing medical devices on the market.
Through independent compliance reviews, importer process development, regulatory assessments, and ongoing advisory support, we help organisations establish practical frameworks aligned with current regulatory requirements.
Whether supporting a new product launch or an established distribution operation, our objective is to provide confidence that importer obligations are being effectively managed while enabling efficient and compliant 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.