Import your CE marked medical devices in Europe and UK and stay compliant with the IVDR/MDR /MHRA regulations. One Import partner for the European market while maintaining an efficient operation, flexibility and independence.
One Medical Device Importer for 50 countries
With over 30 years of combined expertise, GrowthImports is an ISO13485 service provider aimed to ensure the facilitation of a compliant and smooth international MDR/IVDR compliant importing process in the European market.
If you are a non-EU manufacturer of medical devices or In-Vitro Diagnostic devices importing devices into the European Union, you need to comply with the Medical Device Regulation (IVDR/MDR).
The Regulation states manufacturers have to designate an importer that needs to comply with Article 13 of the IV/MDR and will be jointly liable for placing products on the EU market.
An Importer has different responsibilities and liabilities from the other Economic Operators such as the Authorized Representative and Distributors. The manufacturer and the importer are the only economic operators who can place products on the market.
Our team will ensure a smooth onboarding process and will guarantee MDR/IVDR Article 13 compliance through our expertise and QMS system (ISO 13485 pending).
We will provide an infrastructure to coordinate efficiently and transparently with your organization. Based on your number of (expected) importations and primary identifier (UDI-DI), we will put together a plan of action and compensation structure.
We do not physically need to import your goods and have designed the processes in a way to keep your operations as efficient as possible with increased quality standards.
Our main goal is to ensure our clients can import their medical device smooth with limited cost and guaranteed compliance into the European market.
We act as one dedicated import partner for the entire European union so that our clients do not have to deal with multiple importers, multiple systems and processed that can result into increased compliance risks and channel conflicts with distributors.
Read more in our whitepaper about the potential risks and market complications of designating your distributor as your importer.
Are you a Medical Device Distributor based in Europe importing non-EU manufactured CE marked medical devices and wanting to act as an MDR importer for your supplier? We can assist by providing outsourced importing services so you don’t have to hire and setup your own importing department.
A distributor can act as an importer but would need to comply with additional obligations and will be held jointly liable as the manufacturer. As a distributor importing goods, you want to make sure you have an efficient system that is able to distribute your goods efficiently and compliant to the MDR/IVDR regulations.
Ensuring a hassle-free importing experience within Europe, we provide a dedicated fiscal representative to help companies own a VAT number, smoothly Import goods, reclaim VAT and comply with the European TAX and VAT guidelines.
If you as a medical device manufacturer have a European entity and you would like to import the goods yourself, we can provide back-office support to keep your operation lean and avoid extra costs and incompliance risks.
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A complete guide for selling medical and IVD devices successful in Europe