Efficient, MDR/IVDR compliant and cost-effective importing of your medical devices

Comply with article 13 (MDR/IVDR) and designate GrowthImports as your One independent medical device importer for all European and UK markets

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EU-MDR Compliant Importing Services as it should! We know better...

Is your MDR importer Compliant?

If you are a non-EU manufacturer of medical devices you need to comply with the Medical Device Regulation (MDR). The Regulation states manufacturers must select an importer that will have to meet the requirements and will be liable and responsible for placing products on the EU market.

  • What is the definition of an MDR importer?
  • Who can be the MDR importer?
  • How to verify compliance of your MDR importer?
  • Your distributor as your MDR importer?

Risks and market complications of designating distributors

Under the old medical device directives (MDD 93/42/EEC), the requirement for a distributor is not mentioned, while the word importer appears three times. The new MDR (2017/745) implemented per May 26th 2021, revisits the entire supply chain and economic operators, namely: the manufacturer, authorized representative, importers, and distributors. Each economic operator will have replaced and additional responsibilities and liabilities.

No channel conflicts among distributors. Minimize administrative burden. Guarantee compliance.

Secure compliance and efficient importing in Europe and UK

By having one MDR/IVDR compliant independent medical device import partner, you avoid risks, eliminate administrative burden and market conflicts of designating (multiple) distributors as your importer.

One-stop-shop importer

Our turnkey solutions will offer complete efficient importing services. We provide regulatory compliant importing, PRRC services, VAT and tax reclaim, and global sales development services.

A competent trusted partner

With decades of expertise in regulatory and market development services in Europe, you partner with an ISO 13485 certified dedicated organization bringing knowledge, a fast, compliant and smooth onboarding for your importing needs.

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We are your MDR/IVDR Import partner for the European and UK Market.