EU Authorized Representative for medical device and IVD
MDRC
Verified
Greenlight Guru provides the #1 QMS for medical devices, offering an eQMS designed for MedTech innovators. They help companies stay compliant and organized throughout the product lifecycle with AI-powered software and deep industry expertise.
Greenlight Guru is the leading Quality Management System (QMS) provider for medical device companies, offering an electronic QMS (eQMS) tailored for product-led, fast-moving MedTech innovators and established teams alike. Their platform is built to streamline the entire medical device lifecycle, from product development to post-market surveillance, ensuring compliance and efficiency. Leveraging over 500 years of combined industry experience, Greenlight Guru combines AI-powered software with deep expertise to help medical device companies navigate complex regulatory landscapes. Their solutions are designed to keep teams organized, audit-ready, and focused on innovation rather than paperwork. The platform offers flexible, audit-tested quality workflows that integrate with existing tech stacks and support global scale. Greenlight Guru's mission is to improve the quality of life for their customers and patients by solving the unique challenges faced by medical device companies. They offer comprehensive solutions, including professional services and consulting, to support companies at every stage of their commercialization journey. Whether you're a startup or an expanding team, Greenlight Guru provides the tools and support to help your MedTech business grow efficiently and maintain compliance.
About
**Who they are**
EU Authorized Representative for medical device and IVD is a service provider that acts as a liaison between non-EU manufacturers and European regulatory authorities for medical devices and in vitro diagnostic devices. They are designated to represent manufacturers within the European Union.
**Expertise & scope**
* Ensuring compliance with EU MDR 2017/745 and EU IVDR 2017/746.
* Verifying the availability and currency of technical documentation and the EU Declaration of Conformity.
* Confirming that appropriate conformity assessment procedures have been conducted.
* Maintaining copies of technical documentation, EU Declaration of Conformity, and relevant certificates.
* Fulfilling registration obligations within the EU.
* Providing competent authorities with necessary information and documentation upon request.
* Facilitating communication and cooperation with competent authorities regarding samples, device access, and preventive or corrective actions.
* Notifying manufacturers of complaints and suspected incidents reported by healthcare professionals, patients, and users.
**Reputation / proof points**
* The service is referred to by various acronyms including EUAR, EC REP, CE REP, EU REP, or EAR.
EU Authorized Representative for medical device and IVD is a service provider that acts as a liaison between non-EU manufacturers and European regulatory authorities for medical devices and in vitro diagnostic devices. They are designated to represent manufacturers within the European Union.
**Expertise & scope**
* Ensuring compliance with EU MDR 2017/745 and EU IVDR 2017/746.
* Verifying the availability and currency of technical documentation and the EU Declaration of Conformity.
* Confirming that appropriate conformity assessment procedures have been conducted.
* Maintaining copies of technical documentation, EU Declaration of Conformity, and relevant certificates.
* Fulfilling registration obligations within the EU.
* Providing competent authorities with necessary information and documentation upon request.
* Facilitating communication and cooperation with competent authorities regarding samples, device access, and preventive or corrective actions.
* Notifying manufacturers of complaints and suspected incidents reported by healthcare professionals, patients, and users.
**Reputation / proof points**
* The service is referred to by various acronyms including EUAR, EC REP, CE REP, EU REP, or EAR.
Additional information
The role of an EU Authorized Representative is critical for non-EU manufacturers seeking to place medical devices and IVDs on the European market. This representative acts as a point of contact for European authorities and Notified Bodies, ensuring devices meet the stringent requirements of the EU MDR and IVDR. The mandate between the manufacturer and the Authorized Representative must be clearly defined in writing, outlining the specific tasks the representative will undertake. Upon request, a copy of this mandate must be provided to the competent authority. This ensures transparency and accountability in the regulatory process for medical and IVD products entering the EU.
Key Highlights
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Acts as the EU Authorized Representative for medical device and IVD companies.
Source
“EU Authorized Representative for medical device and IVD Companies”
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Ensures technical documentation and EU Declaration of Conformity are available and up-to-date.
Source
“make sure that the EU declaration of conformity and technical documentation are available and kept up to date;”
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Verifies that appropriate conformity assessment procedures have been carried out.
Source
“verify that an appropriate conformity assessment procedure has been carried out;”
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Cooperates with competent authorities on any preventive or corrective actions.
Source
“cooperate with the competent authorities on any preventive or corrective actions;”
Certifications & Trust Signals
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Serves as a point of contact for European authorities and Notified Bodies.
Source
“Specifically, Authorized Representatives play a pivotal role in ensuring the compliance of the devices and in serving as point of contact for the European authorities and Notified Bodies.”
Buyer Snapshot
Best for
- Non-EU manufacturers of medical devices and IVDs
- Companies seeking to comply with EU MDR and IVDR
How engagement typically works
- Mandated representation
- Liaison with EU authorities
Typical deliverables
- Regulatory compliance assurance
- Documentation management support
- Communication channel with authorities
- Incident and complaint reporting facilitation
Good to know
- Requires a written mandate agreement
- The representative acts on behalf of the manufacturer for specified tasks
HQ:
United States, USA
Website:
mdrc-consulting.com
Public email:
letschat@greenlight.guru
Phone:
+49 176 67510274
Languages:
English
Timezones:
EST
Access:
Verified
Claim status:
Listed
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU
Countries:
EU
Industries:
Medical Devices, Pharmaceuticals, Biotech
Onboarding time:
7–21 days
Pricing model:
Custom pricing
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
IVD
Post Market Support:
Yes
Labeling Review:
Yes
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Fsca Recall Support:
Yes
Alternate Names:
EUAR, EC REP, CE REP, EU REP, EAR
EU Entity Country:
EU
Additional eu_ar Details
Device Classes Supported
All
Supports MDR
Yes
Supports IVDR
Yes
EU Entity Country
EU
Fsca Recall Support
Yes
Post Market Support
Yes
Vigilance Contact Support
Yes
Onboarding Steps
Requires a written mandate agreed between the EC REP and the manufacturer.
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