Guarantee Compliance, Stay Efficient
By having one MDR/IVDR compliant independent import partner for all Europe, you avoid risks and
market conflicts of designating distributors or multiple importers.
With decades of expertise in regulatory and market development services in Europe, you partner with a dedicated organization bringing knowledge, a fast and smooth onboarding and helping you achieve your European importing needs.
The MDR/IVDR (2017/745) Regulation stipulates non-EU manufacturers placing CE marked products in the European Union will need to designate an 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..
Even if you are selling CE marked medical devices under the MDD/IVDD, if you are exporting to Europe, you do require an EU MDR of record importer.
By working closely with your team from the beginning, we will ensure alignment and a smooth onboarding process. We will together determine the scope and formalize these in our agreement. Based upon your number of (expected) importations and primary identifier (UDI-DI), we will 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.
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:
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.
Our expert consultants are ready to explore your international growth opportunities!