MedNet EC-REP (Regulatory Importer)
MedNet EC-REP GmbH
MedNet EC-REP is your expert partner for regulatory representation in European markets, ensuring seamless access for non-EU products to the EU, Great Britain, and Switzerland.
MedNet EC-REP specializes in providing comprehensive regulatory representation for non-EU manufacturers seeking to access European markets. As your European Authorized Representative (EC-REP), UK Responsible Person (UK RP), and Swiss Authorized Representative, we facilitate market entry for medical devices, in-vitro diagnostics, cosmetics, and personal protective equipment. Our services encompass ensuring sustained product compliance throughout its lifecycle, managing regulatory inquiries, mitigating risks, and acting as the primary contact point for competent authorities. We offer specialized support for clinical investigations, IVD performance evaluations, and product registration across the EU, UK, and Switzerland, navigating complex regulations like MDR and IVDR. With headquarters in Germany and a strong presence in the UK and Switzerland, MedNet EC-REP guarantees fast communication and a deep understanding of local regulations. We help you achieve CE marking, manage labeling requirements, and obtain Free Sales Certificates for global market expansion, ensuring your products meet all necessary standards for safety and effectiveness.
About
**Who they are**
MedNet EC-REP (Regulatory Importer) is an expert partner for regulatory representation and market access in European markets, including the EU, Great Britain, and Switzerland. With over 30 years of experience, they facilitate the entry of non-EU products into these regions.
**Expertise & scope**
* **Regulatory Representation:** Acts as an EC-REP (European Authorized Representative) and UK Responsible Person (UK RP) for medical devices and IVDs.
* **Importer Services:** Provides independent and conflict-free regulatory importer services for medical devices and IVDs, ensuring compliance with EU MDR/IVDR Article 13.
* **Product Registration:** Assists with quick and uncomplicated product registration in relevant national databases across the EU, UK, and Switzerland.
* **Cosmetics Compliance:** Offers Responsible Person services for cosmetics, ensuring compliance with EU and UK regulations, including CPNP and OPSS notifications.
* **Free Sales Certificates:** Supports EU-based manufacturers in applying for Free Sales Certificates to facilitate sales in non-EU countries.
* **Clinical Investigations:** Provides legal representative services for clinical investigations, ensuring compliance with EU regulations and acting as a liaison with regulatory authorities.
* **IVD Performance Evaluations:** Specializes in ensuring compliance with IVDR for IVD performance evaluations.
**Reputation / proof points**
* Over 30 years of experience in regulatory affairs.
* Headquartered in Germany, operating within the EU.
MedNet EC-REP (Regulatory Importer) is an expert partner for regulatory representation and market access in European markets, including the EU, Great Britain, and Switzerland. With over 30 years of experience, they facilitate the entry of non-EU products into these regions.
**Expertise & scope**
* **Regulatory Representation:** Acts as an EC-REP (European Authorized Representative) and UK Responsible Person (UK RP) for medical devices and IVDs.
* **Importer Services:** Provides independent and conflict-free regulatory importer services for medical devices and IVDs, ensuring compliance with EU MDR/IVDR Article 13.
* **Product Registration:** Assists with quick and uncomplicated product registration in relevant national databases across the EU, UK, and Switzerland.
* **Cosmetics Compliance:** Offers Responsible Person services for cosmetics, ensuring compliance with EU and UK regulations, including CPNP and OPSS notifications.
* **Free Sales Certificates:** Supports EU-based manufacturers in applying for Free Sales Certificates to facilitate sales in non-EU countries.
* **Clinical Investigations:** Provides legal representative services for clinical investigations, ensuring compliance with EU regulations and acting as a liaison with regulatory authorities.
* **IVD Performance Evaluations:** Specializes in ensuring compliance with IVDR for IVD performance evaluations.
**Reputation / proof points**
* Over 30 years of experience in regulatory affairs.
* Headquartered in Germany, operating within the EU.
Additional information
MedNet EC-REP emphasizes an independent approach to regulatory importer services, distinguishing itself from distributors to avoid conflicts of interest and ensure unbiased compliance verification. They offer full transparency and ongoing support throughout a product's lifecycle in the EU market. For manufacturers seeking to enter the EU, UK, or Switzerland, MedNet EC-REP provides a comprehensive suite of services, including product registration, acting as an authorized representative, and ensuring adherence to specific regulations like MDR and IVDR. Their services are designed to streamline market access and mitigate risks associated with non-compliance, making them a strategic partner for global manufacturers.
Key Highlights
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Over 30 years of experience in regulatory affairs for European markets.
Source
“With over 30 years of experience we are your trusted partner in the european Union, Great Britain and Switzerland.”
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Provides independent Regulatory Importer services, distinct from distributor roles, ensuring conflict-free compliance.
Source
“Unlike distributors, MedNet EC-REP operates independently, focusing solely on compliance rather than commercial interests.”
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Acts as EU Authorized Representative (EC-REP) and UK Responsible Person (UK RP) for medical devices and IVDs.
Source
“An EC-REP, or European Authorized Representative, is a legal entity established within the European Union that acts on behalf of a non-EU manufacturer...”
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Facilitates product registration across EU, Great Britain, and Switzerland.
Source
“We help you to register your products in the national databases.”
Certifications & Trust Signals
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Established presence in the geographic heart of the EU with headquarters in Germany.
Source
“With our EU headquarters in Germany, we are based in the geographic heart of the Union...”
Buyer Snapshot
Best for
- Non-EU manufacturers seeking market access to the EU, UK, and Switzerland.
- Companies requiring an independent EU Regulatory Importer.
- Manufacturers of medical devices, IVDs, and PPE needing regulatory representation.
How engagement typically works
- Proactive regulatory support and guidance.
- Facilitation of market entry and compliance.
- Liaison with regulatory authorities.
Typical deliverables
- Appointed EU Authorized Representative (EC-REP).
- Appointed UK Responsible Person (UK RP).
- Registered products in national databases.
- Compliance documentation review and support.
- Free Sales Certificates.
- Cosmetics notifications.
Good to know
- Best when manufacturers require dedicated regulatory expertise for complex European markets.
- Ideal for companies prioritizing independent compliance verification.
HQ:
Germany, Germany
Languages:
English, German
Timezones:
Europe/Berlin
Status:
listed
Services & Capabilities
Importer & Distributor Compliance Support
Jurisdictions:
EU
Countries:
DE, AT, NL, BE, FR
Industries:
Medical devices, Healthcare, Distribution
Portfolio:
6-25, 26-100
Onboarding time:
2–22 days
Pricing model:
Retainer
Starting from:
EUR 2,800
Included services:
Importer/Distributor SOP & template pack, Training for economic operator obligations, Compliance gap scan, Audit readiness support, Ongoing compliance support
Deliverables:
Ongoing retainer
Role Coverage:
Importer
Additional importer_distributor_compliance Details
Role Coverage
Importer, Authorized Representative, Responsible Person
Supports MDR
Yes
Supports IVDR
Yes
Verification Support
Yes
Storage Conditions Support
No
Onboarding Steps
Requires appointment of MedNet EC-REP GmbH as Regulatory Importer or EU Authorized Representative. Facilitates product registration in national databases. Supports application for Free Sales Certificates by checking compliance with EU Regulations and gathering necessary information.
Device Classes Supported
Medical Devices (all classes implied), IVDs
