Regulatory Importer
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
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.