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. 

FREE IMPORTING ANALYSIS

Identify gaps and optimize your current importing structure

Why you need MDR/IVDR Regulatory Importing Services

Under Article 13 MDR a, importers must meet strict regulatory standards. Ensuring compliance in your supply chain is critical not only for legal repercussions but also to avoid quality issues, commercial and reputation damage.

GrowthMedics, as your dedicated EU MDR / IVDR importer, offers a comprehensive solution to help you meet all EU MDR / IVDR importer requirements while enabling you to focus on scaling your business.

  • Streamlined Processes
    Utilize one labeling, onboarding, and tracking process across all EU markets, simplifying medical device import requirements and reducing administrative burdens.
  • Expanded Market Access
    Ship seamlessly to all EU countries, Switzerland, and the UK without the need for multiple importers.
    GrowthMedics assumes liability, ensuring compliance with EU MDR importer requirements and smooth operations.
  • Faster Market Entry
    Pre-onboarding with GrowthMedics ensures compliance-ready labels and processes, expediting distributor onboarding.
  • Conflict-Free Distributor Relations.
    Prevent conflicts over medical device import licenses and regulatory responsibilities by designating GrowthMedics as a neutral, independent importer.
  • Reduced Administrative Burden
    Simplify your import-export medical devices processes, including labeling, registration, and compliance management, while minimizing costs.

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.

How we make MDR/IVR Compliance Possible

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) imports and primary identifier (Basic UDI-DI), we will put together a plan of action and compensation structure.
In a step by step approach we will integrate an efficient importing process for your shipments to the Union.

  1. Onboarding: Verification of documentation and compliance with medical device import licenses and IVDR importer requirements.
  2. Shipment Tracking: Digital tracking and monitoring of shipments across the EU.
  3. Labeling & Registration: Ensure compliance with MDR/IVDR labeling and registration protocols.
  4. Post-Market Surveillance: Ongoing monitoring and auditing to ensure compliance with EU regulations.
  5. Customer & Logistics Support: End-to-end support for efficient importing and distribution.
How we make MDR/IVR possible

Benefits of working with Growth Imports

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Frequently Asked Questions

What sets your service apart from other importers?

We combine a proven track record in driving sales growth for global medical device and IVD manufacturers with expertise in regulatory compliance, logistics, and fiscal tax solutions. By managing hundreds of distribution partnerships across Europe and the Middle East, we act as a true growth partner, supporting your expansion at every stage.

You can directly ship your goods to your end-users or distributors. Our procedures are designed to manage shipments and processes digitally.

We have pricing structures depending on your number of importations and structure of your importing. We have a cost-effective approach with the goal to grow with your growth.

Our regulatory importing services can be applied to all European markets, including Switzerland and the United Kingdom.

Once we have an agreement, we will start the onboarding process by requesting documentation for the audit. Typically in 1 to 3 weeks depending on a complete submission.

Looking for more distributors in Europe?

Our Approach has Led Numerous Medical Companies become Successful in International Markets. Accelerate your Sales in International Markets with the experience and expertise of Growth Medics!

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