YOUR GATEAWAY TO EUROPE:
Expert Regulatory Representation & Importer Services for Medical Device and IVD Manufacturers

MedNet EC-Rep GmbH is a leading partner for non-European manufacturers seeking reliable, compliant access to EU, UK, and Swiss markets. With over 30 years of experience, ISO 13485 certification, and expert teams in Germany, the UK, Switzerland, and China, MedNet supports the complex regulatory environment as your:

• European Authorized Representative (EU-REP / EC-REP)

• Swiss Authorized Representative (CH-REP)

• UK Responsible Person (UK RP)

• Regulatory Importer

• Legal Representative / Swiss Agent for Clinical Trials

European, Swiss, and UK Authorized Representation
MedNet acts as your official contact for authorities across these regions, ensuring market access and compliance. Our services include managing post-market surveillance, vigilance reporting, thorough document review, and guaranteeing documentation availability for competent authorities at all times. We expertly support your regulatory obligations throughout the full product lifecycle.

Regulatory Importer Services
As your Regulatory Importer, we take on all obligations required under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), managing product compliance at first placement on the EU market. This ensures legal access, full regulatory oversight, and robust documentation for manufacturers and distributors alike.

Legal Representation & Swiss Agent - Supporting Your Clinical Trials
Clinical and performance studies in the EU, UK, and Switzerland often require appointment of a Legal Representative or Swiss Agent. MedNet acts as your dedicated partner for clinical study submissions, streamlining approvals and ensuring all required documentation is always available for regulatory authorities. This service accelerates your pathway to market and safeguards your clinical projects.

Cosmetics - Responsible Person for EU & UK
Under European Cosmetics Regulation 1223/2009, MedNet acts as your Responsible Person in the EU and UK, managing Cosmetic Product Notification Portal (CPNP) and Office for Product Safety and Standards (OPSS) registrations. We ensure a swift, compliant market launch, helping you maintain full regulatory compliance and long-term success in the cosmetics sector.

General Products - EU Authorized Representative under GPSR
Effective since December 2024, the EU General Product Safety Regulation (GPSR) introduced new safety and documentation requirements for general products not covered by sector regulations. MedNet acts as your EU-REP for general products, guiding you through GPSR compliance to ensure your products meet the highest safety standards and regulatory obligations.

Key Service Areas at a Glance:

• European, Swiss, and UK Authorized Representation: Official contact, market access, compliance, post-market surveillance, vigilance reporting, document review, and availability

• Regulatory Importer Service: Full importer responsibilities under MDR/IVDR

• Legal Representative | Swiss Agent: Clinical and performance study approvals in the EU, UK, and Switzerland

• Cosmetics Responsible Person: CPNP and OPSS registrations for fast cosmetic market entry

• General Product EU-REP Service: Compliance support under GPSR

• Product Registration: Efficient, reliable registrations and approvals

• Regulatory Guidance: Qualified advice on MDR, IVDR, CE Marking, GPSR, and more

• Legalizations & Free Sales Certificates: Streamlined global support for exports
   

Why global manufacturers trust MedNet EC-Rep:

• Over 30 years of deep regulatory expertise

• Trusted by more than 700 international clients

• ISO 13485-certified quality management

• Solution-oriented, full-service regulatory partnership

• Multilingual, international, highly qualified team
   

Unlock your product’s potential in Europe and beyond - MedNet EC-Rep GmbH is your partner for regulatory excellence in Europe.

Do you have questions about our Regulatory and Importer Services, EUDAMED, MDR/IVDR requirements, or Notified Body processes?
Then visit us at WHX in Dubai - we look forward to meet you in person!
 

MedNet EC-REP GmbH
Borkstrasse 10, 48163 Münster, Germany
P +49-251-322-66-64
contact@mednet-ecrep.com
www.mednet-ecrep.com