Consolidated Single EU, UK & CH Independent MDR/IVDR Regulatory Importer
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Secure seamless and compliant placement of your CE marked devices
Reduce Compliance Risk and
Simplify EU, UK and CH Independent Market Access - MDR/IVDR Article 13 Compliant
By working with a single independent EU importer, you reduce regulatory risk, avoid distributor conflicts, enable direct shipments, less dependency on your distributors and streamline your supply chain—without establishing a European legal entity.
Under the EU MDR/IVDR, the regulatory importer assumes significant legal responsibilities. They are formally responsible for placing the product on the EU market and must ensure compliance tasks.
Regulatory Onboarding
< 5 DAYS
Shipments in the EU, UK, CH market
We verify your technical documentation, CE certification, declarations, and EUDAMED registrations to ensure full alignment with EU MDR/IVDR Article 13 requirements before placement on the market
MDR / IVDR Labelling
24–48 hr
Shipments Cleared in 24–48 Hours
We ensure correct importer labelling, UDI compliance, and required registrations in accordance with EU regulations.
EU Shipment Traceability
100%
Client Retention Rate
All shipments are digitally reviewed and tracked to maintain full device traceability within the EU supply chain.
Compliance Auditing
1
Integrated Partner for all EU, UK & CH markets
We conduct structured periodic audits of documentation and shipment processes to verify continued regulatory conformity.
Post-Market Surveillance
100%
Keep control without complications
We support ongoing PMS oversight and mandatory serious incident reporting to EU competent authorities where required.
Using distributors as your importer can create regulatory risk, operational complexity, and loss of commercial control — especially across multiple EU markets.
With GrowthMedics as your independent EU Regulatory Importer, you gain one consolidated, compliant import structure while retaining full control to ship directly to distributors, online platforms such as Amazon or end-users such as hospitals, patients or healthcare professionals across Europe.
Supply Chain Control & Direct Shipping
- Maintain full control of your EU supply chain by shipping directly to distributors and end-users without delays or channel dependency
- Keep flexibility to add or switch distributors without relabelling disruption.
- Ensure legal oversight without the need for physical receipt of goods, where applicable.
One Standardized EU Process
- Operate with one harmonized onboarding, labelling, and shipment tracking structure across all EU markets, reducing administrative burden and complexity.
Multi-Market Coverage, One Importer
- Ship seamlessly across the EU, Switzerland, and the UK under one consolidated import structure — no need for multiple local importers.
Full MDR / IVDR Article 13 Compliance
- GrowthMedics acts as your independent EU Regulatory Importer, assuming importer obligations and operating in alignment with Article 13 MDR/IVDR and ISO 13485 standards.
Faster Market Entry
- Pre-onboarding and compliance-ready labelling streamline distributor activation and accelerate time to market.
Neutral & Conflict-Free Channel Structure
- Avoid distributor conflicts related to import responsibilities by appointing a neutral, independent importer that protects your commercial position.
One Hub. Total European Access.
Centralized Importer & Logistics point
Virtual Seamless Importing
4PL operational support
Conflict Free Distrubutor Relations
Demonstrated Expertise
What Our Clients Say
“We really appreciate the dedication and methodical approach by GrowthMedics team demonstrated in helping our registration and marketing in the EU market”
Luke Gao PhD
CEO Panacyte Scientific LLC.
“We have been working with Growth Medics to increase awareness of our software solutions in the Medical Device Industry. Growth Medics team have a deep knowledge and understanding or our industry and were very professional”
Louis Albert - CEO
“The team is diligent and professional in its approach to understanding our company and creating pathways to new markets. We recommend GrowthMedics as a partner to assist with European expansion plans”
Managing Director-Principal
“GrowthMedics’ team is highly strategic and experienced professionals. Their extensive knowledge of the global healthcare market, along with their targeted approach to business development, makes them a great asset to work alongside”
Kareem Sherif
“When working with the managing director of GrowthMedics, he was always incredibly helpful and understanding of our organizational needs regarding expansion in international markets. He took his time to understand our business and product offering to help provide tailored solutions aimed at taking our business to the next level”
Chad Gottschalk
“GrowthMedics played a vital role in our international development. Their network, team, experience and deep industry knowledge helped us grow our market share in Europe. By acting as our European sales arm, they have successfully established and managed a network of distributors and clinics across European markets”
Sebastien Lachapelle
“Expanding into new markets internationally recently has been especially challenging. GrowthMedics gets doors opened, is very efficient and follows through. We highly recommend GrowthMedics for their help expanding our footprint in Europe and MENA.”
J. Mark Strong
“ We are delighted to work with Growth Medics in developing the European Union market. The team have been most professional, diligent and committed to our joint success”
Max Kanarsky
