Since Brexit, UK requires its own medical device importing regulatory requirements (MMDA) for non-UK manufacturers exporting to Great Britain. With GrowthImports as your dedicated independent importer you comply with regulatory requirements, ease market access, reduce dependency on distributors and avoid channel conflicts.
Guarantee Compliance, Stay Efficient
The importer will be held jointly liable for products placed in the market and any incompliance will disrupt shipping goods to Great Britain (England, Wales and Scotland). As a manufacturer you want to ensure your importer is regulatory compliant, have an efficient and cost-effective process and limit dependency on your channel partners such as your distributors. A UK MHRA importer also applies for UKCA marked devices or legacy devices and has different responsibilities than a UKRP.
The UK Medicines and Medical Devices Act (MMDA) is in place after Brexit and requires non-UK manufacturers to designate a UK based importer to comply with the regulations. The importer of record will be held jointly liable for all products placed in the market and has the responsibility to fulfill regulatory requirements.
Currently the MHRA is reviewing to implement updated regulations by the end of 2022 and has announced in its consultation (section 13.1) the intention to further implement more strict requirements with regards to reporting and traceability.
If you are taking our EU importing services we can easily accelerate the onboarding process and combine efforts to reduce efforts and cost.
Once the scope of the agreement has been formalized in a contract, we will based upon your number of (expected) importations and primary identifier (UDI-DI), put together a plan of action and compensation structure.
The onboarding will include a submission document checklist that can be uploaded on our cloud based portal allowing us to exchange information efficiently and secured. Once we have verified all documents you will receive an importer statement and we will start the importing process. Our approach does not require a physical importation so your shipments can be send directly to your customer.
Our staged growth development framework contains deliverables and an actionable planning aimed to evaluate, optimize and exceed global growth objectives of our Clients.
We have designed our verification process in line with the MDR/IVDR requirements so manufacturers and we as the importer are regulatory compliant before placing products on the EU market. Our verification process includes:
After the verification process we will conduct the necessary registrations in the MHRA portal. During our engagement we will verify and record each shipment and conduct audit inspections.
Once the products are placed in Great Britain the role of the importer does not stop. We will continue to have the responsibility to maintain a compliant process and be available for the competent authorities.
Avoid channel conflicts among distributors, eliminate the need of working with multiple distributors or importers creating increased compliance risk and administrative burdens. Our services will reduce the thresold of market access through distributors, save time and create focus on selling among distributors.
You will work with us as one MHRA and ISO 13485 compliant Importer that will ensure guaranteed compliance and alignment with your team and processes to secure an efficient process. Read more about the compliance risks of working with distributors as your importer or multiple importers here.
Our expert consultants are ready to explore your international growth opportunities!