Hassle-Free MDR/IVDR Compliant Importing
Import your CE-marked medical devices seamlessly into Europe. With GrowthImports as your dedicated EU MDR importer, we guarantee full MDR and IVDR compliance. Maintain control over your products, eliminate channel conflicts, and ensure efficient operations. As your independent import partner, we provide end-to-end support for all your European needs.
Guarantee Compliance, Stay Efficient
By working with a single, MDR/IVDR-compliant EU importer, you avoid the risks and complications of managing multiple distributors or importers. With GrowthImports as your partner, you streamline your entry into the European market, minimize compliance risks, and maintain clear control over product distribution.
With decades of expertise in regulatory compliance and European market development, our team provides a smooth onboarding process, dedicated compliance support, and tailored solutions to meet your unique import needs. Let us help you navigate the complex world of EU MDR importer requirements so you can focus on growing your business in Europe.
The MDR/IVDR (2017/745) Regulation stipulates non-EU manufacturers placing CE marked medical devices in the European Union will need to designate an authorized EU MDR importer. The MDR importer will be jointly liable for products placed on the market and requires to comply with the obligations listed in Article 13 MDR/IVDR, such as verifying conformity documentation, CE marking, and ensuring that the product meets EU regulatory requirements.
Even if you are already selling CE-marked medical devices under the MDD/IVDD, exporting these to Europe requires compliance with updated MDR/IVDR regulations. You need an EU MDR of record importer to maintain seamless market access and regulatory compliance.
To comply with EU MDR importer requirements, companies must designate an authorized representative or distributor within the European Union who ensures that the medical devices meet MDR standards. This EU MDR importer is responsible for checking documentation, maintaining communication with the manufacturer, and ensuring the safe distribution of the products across Europe.
If you are a medical device distributor in Europe, understanding these importer requirements is essential to streamline your processes and avoid compliance issues. Non-compliance can lead to costly penalties and product recalls, disrupting the supply chain and impacting your reputation.
At GrowthImports, we work as your dedicated EU importer for medical devices, providing a streamlined onboarding and compliance process that eliminates complexities. By working closely with your team from the beginning, we ensure alignment and a smooth onboarding process tailored to the specific requirements of the medical device distribution industry in Europe.
Together, we will determine the scope of your import activities and formalize this in our service agreement. Based on your expected volume of imports and Unique Device Identifier (UDI-DI), we will develop a structured plan of action and compensation structure, ensuring full compliance with all MDR/IVDR requirements.
Our onboarding process includes a comprehensive checklist of all submission documents, which can be uploaded on our secure cloud-based portal. This ensures efficient and secure information exchange and transparency throughout the process.
Once we verify all documents, you will receive an importer statement, marking the start of the importing process. Our unique approach allows for direct shipment to customers within the EU, so no physical import is required on your end. Your shipments can be dispatched directly, ensuring faster delivery times and reduced logistics costs.
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 medical device distributors in Europe by reducing the need to work with multiple EU MDR importers. Managing multiple distributors and importers can increase compliance risk and administrative burdens, especially under strict EU MDR importer requirements. Our services streamline this process, lowering the threshold for market access while ensuring full MDR/IVDR compliance. This allows EU importers of medical devices to focus on core selling activities and minimize compliance-related disruptions.
Our expert consultants are ready to guide you through the complexities of medical device distribution in Europe. Book a meeting to discover how we can help you meet EU MDR importer requirements and unlock your growth potential in the European market!