Medical Device Importing services Europe

Hassle-Free MDR/IVDR Compliant Importing

Import your CE marked medical devices in Europe. Guarantee MDR and IVDR compliance while maintaining control, avoid channel complications and an efficient operation. One dedicated independent import partner for all your European needs.

Guarantee Compliance, Stay Efficient

One Independent Medical Device Importer for the Europe Union

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. 

MDR / IVDR Importer Regulations

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. 

Our Approach

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.

MDR/IVDR Importing Services

Maintain Efficiency, Eliminate Compliance Risk and Minimize cost

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.

 

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