guides
PPWR Quick Guide: EU PPWR Compliance Steps for Medical Device and IVD Manufacturers
The EU PPWR applies from 12 August 2026, no grace period. See the compliance steps medical device and IVD manufacturers need now. Read the guide.
Read moreTrusted by 700+ Companies Worldwide
Your Partner for Regulatory Excellence in Europe
Comprehensive Authorized Representative, Importer, and regulatory compliance services for medical devices, cosmetics, and consumer products across the EU, UK, and Switzerland.
ISO 13485 Certified
30+ Years of Experience
29+ Countries
Industries We Serve
Your European Authorized Representative for a Wide Range of Regulated Products
From medical devices to cosmetics, we provide comprehensive regulatory representation services tailored to your industry's specific requirements.
Market Coverage
Your Single Source to All European Markets
Access the European Union, Great Britain, and Switzerland through one trusted partner. We handle all regulatory requirements so you can focus on your business.
One Partner, Three Markets
With offices in Germany, the UK, and Switzerland, we provide seamless regulatory representation across all European markets.
Our Services
Comprehensive Regulatory Representation Services
From authorized representation to product registration, we provide regulatory services that simplify your European market entry.
Additional Services
Why MedNet EC-REP
Your Partner for Regulatory Excellence in Europe
We combine decades of regulatory expertise with personalized service to ensure your products reach European markets quickly and compliantly.
PhD-Level Expertise
Expert Team
Our team of PhD biologists, medical engineers, and regulatory specialists brings unmatched expertise to every project. We understand the science behind your products.
Dedicated Support
Personal Contact Person
Every client receives a dedicated contact person from our regulatory affairs team. One point of contact for all your needs – no call centers, no ticket systems.
Proven Track Record
30+ Years Experience
Since our founding, we have helped hundreds of manufacturers navigate European regulations. Our experience means fewer surprises and faster market access.
4 Strategic Locations
Global Reach, Local Expertise
With offices in Germany, Switzerland, the UK, and China, we provide truly global service with deep local regulatory knowledge in each market.
Certified Quality
ISO 13485 Certified
Our quality management system is ISO 13485:2016 certified, ensuring consistent, high-quality service delivery for all our clients.
24-48h Response
Fast Response Times
We understand that time is critical in regulatory matters. Our team responds quickly to inquiries and keeps your projects moving forward.
Our Focus
We specialize in regulatory representation services. We do not offer consultancy or writing of technical documentation – we focus on what we do best: representing your interests to European authorities.
Client Success Stories
Trusted by Manufacturers Worldwide
Discover why leading medical device, IVD, and cosmetics manufacturers choose MedNet EC-REP as their European regulatory partner.
"As we advance our medical device business in Europe, we have been greatly helped by MEDNET’s prompt and appropriate support, primarily with respect to medical device regulatory compliance. We appreciate and look forward to your continued support."
S
Shintaro Nakagawa - Medical Planning and Development Department
Yamagata Casio Co., Ltd
Medical DevicesJapan
Latest News
regulatory updatesNew EU Study: Where Manufacturers and Authorised Representatives Really Stand on MDR and IVDR
New EU study finds 48% of manufacturers have withdrawn devices from the market. Key MDR/IVDR and AR findings for 2026. Read the numbers now.
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regulatory updatesWell-Established Technologies Under the MDR: EU Commission Expands Exemption List
The EU Commission has expanded the WET list under the MDR, easing requirements for certain class II and class III devices.
Read more
Latest Videos
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Medical DevicesIVDs
Non-EU Manufacturers: Appointing an Authorized Representative (EC-REP) for Medical Devices and IVD`s
Discover how MedNet EC-REP GmbH simplifies EU compliance for medical device and IVD manufacturers with authorized representative and seamless registration services.
Mar 2, 2026
2:54
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Medical DevicesIVDs
Regulatory Importer Service for Medical Devices Explained
Discover how MedNet EC-REP’s Regulatory Importer Service streamlines EU market access for medical devices. This video explains the role and responsibilities of an importer. Learn how our service ensures seamless, compliant shipments to your European customers.
Apr 29, 2025
3:38
Cosmetics
Responsible Person under the EU Cosmetic Products Regulation 1223/2009
Responsible Person under the EU Cosmetic Products Regulation 1223/2009
Jan 10, 2025
1:53
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