MedEnvoy
MedEnvoy simplifies medical device, IVD, and cosmetic market entry into EU, UK, and Switzerland with expert regulatory representation and importer ser
MedEnvoy simplifies bringing medical devices, IVDs, and cosmetics to market by overcoming complex regulations. They offer expert In-Country Representation and Regulatory Importer services for the EU, UK, and Switzerland, acting as a single, independent point of contact
About
MedEnvoy is a provider of in-country representation and regulatory importer services for medical device, IVD, and cosmetic manufacturers. They focus on simplifying market entry into the EU, UK, and Switzerland.
**Who they are**
MedEnvoy empowers small and medium-sized companies in the health care and life sciences industries by offering consolidated services to meet local regulatory requirements in key international markets. They aim to be a trusted partner in bringing health solutions to markets worldwide with speed and quality.
**Expertise & scope**
* EU Authorized Representative (EU AR/EAR) services for medical device and IVD manufacturers without an EU registered office, ensuring compliance with EU MDR and IVDR.
* Assistance with transitioning from existing EU AR support, managing the process and preparing tripartite agreements.
* Services also include UK Responsible Person, Swiss Authorized Representative, US FDA Agent, Mexico Registration Holder, Egypt Registration Holder, Saudi Arabia Authorized Representative, Israel Registration Holder, India Agent, and Australian TGA Sponsor.
**Reputation / proof points**
* Established in the Netherlands by experienced regulatory affairs executives.
* Successfully transitioned over 150 medical device and IVD manufacturers.
**Who they are**
MedEnvoy empowers small and medium-sized companies in the health care and life sciences industries by offering consolidated services to meet local regulatory requirements in key international markets. They aim to be a trusted partner in bringing health solutions to markets worldwide with speed and quality.
**Expertise & scope**
* EU Authorized Representative (EU AR/EAR) services for medical device and IVD manufacturers without an EU registered office, ensuring compliance with EU MDR and IVDR.
* Assistance with transitioning from existing EU AR support, managing the process and preparing tripartite agreements.
* Services also include UK Responsible Person, Swiss Authorized Representative, US FDA Agent, Mexico Registration Holder, Egypt Registration Holder, Saudi Arabia Authorized Representative, Israel Registration Holder, India Agent, and Australian TGA Sponsor.
**Reputation / proof points**
* Established in the Netherlands by experienced regulatory affairs executives.
* Successfully transitioned over 150 medical device and IVD manufacturers.
Additional information
MedEnvoy emphasizes leveraging digital and AI technologies to deliver efficient, high-quality solutions. They are committed to building strong customer relationships and ensuring that patients globally can access safe and innovative healthcare products that meet high standards of quality and local regulatory compliance. Their services are designed to enable clients to focus on innovation and growth by managing regulatory complexities.
Key Highlights
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MedEnvoy provides EU Authorized Representative services, ensuring compliance with EU MDR and IVDR for medical device and IVD manufacturers.
Source
“Optimize your regulatory compliance and control with MedEnvoy as your EU Authorized Representative for medical device and IVD manufacturers.”
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They offer expertise in transitioning over 150 medical device and IVD manufacturers to their services, managing the process with tripartite agreements.
Source
“With extensive experience, we’ve successfully transitioned over 150 medical device and IVD manufacturers to MedEnvoy.”
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MedEnvoy's mission is to empower small and medium-sized companies in health care and life sciences with consolidated services for international market entry.
Source
“MedEnvoy’s mission is to empower small and medium-sized companies in the health care and life sciences industry by providing consolidated services to meet local regulatory requirements in key international markets.”
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Coverage includes EU, UK, and Switzerland, alongside representation services in other global markets.
Source
“EU Authorized Representative, UK Responsible Person, Swiss Authorized Representative”
Certifications & Trust Signals
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Established in the Netherlands by experienced and reputable regulatory affairs executives.
Source
“Established in the Netherlands by experienced and reputable regulatory affairs executives, MedEnvoy”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking EU Authorized Representation.
- Companies without an EU registered office needing market access.
- Small and medium-sized companies in health care and life sciences.
How engagement typically works
- Partnership focused on customer relationships.
- Leveraging technology for efficient solutions.
- Facilitating smooth transitions from existing representatives.
Typical deliverables
- EU Authorized Representative appointment.
- Tripartite agreement preparation.
- Regulatory representation for EU, UK, and Switzerland.
- Support for market entry in multiple international regions.
Good to know
- Best when clients require specialized regulatory representation for health and life sciences products.
- Best when clients are looking to streamline market entry and compliance across multiple regulated markets.
HQ:
Seattle, United States
Languages:
English
Timezones:
America/Los_Angeles
Status:
listed
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU, UK, CH
Countries:
IE, DE, FR, NL, BE
Industries:
Medical devices, IVD, Healthcare
Portfolio:
26-100, 100+
Onboarding time:
3–21 days
Pricing model:
Retainer
Starting from:
EUR 7,500
Included services:
EU Authorized Representative (EC REP) designation, Authority liaison and document availability support, Vigilance escalation and FSCA coordination, Labeling/EC REP identification review, Post-market support workflows (complaints, vigilance escalation)
Alternate Names:
EAR, EU AR, EC REP, CE REP, EU REP
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
IVD
Post Market Support:
Yes
Labeling Review:
Yes
EU Entity Country:
European Union
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
eudamed_onboarding_support
Additional eu_ar Details
Supports MDR
Yes
Supports IVDR
Yes
EU Entity Country
Netherlands
Onboarding Steps
Process includes preparing a tripartite agreement for smooth and cost-effective transition.
Post Market Support
Yes
Device Classes Supported
Medical Device, IVD
