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 companies acts as the mandated representative within the European Union for non-EU manufacturers placing medical devices and in vitro diagnostic devices on the market. They serve as a crucial point of contact for European authorities and Notified Bodies.
**Expertise & scope**
* Ensuring compliance with EU MDR 2017/745 and EU IVDR 2017/746.
* Verifying the availability and currency of technical documentation and EU declarations of conformity.
* Confirming that appropriate conformity assessment procedures have been undertaken.
* Managing registration obligations within the EU regulatory framework.
* Facilitating communication between competent authorities and manufacturers.
* Cooperating with authorities on preventive and corrective actions.
* Promptly informing manufacturers of complaints and suspected incidents reported by healthcare professionals, patients, and users.
* Providing competent authorities with necessary information and documentation upon request.
* Forwarding requests for device samples or access to competent authorities and verifying compliance.
**Reputation / proof points**
* The service is offered by MDRC.
EU Authorized Representative for medical device and IVD companies acts as the mandated representative within the European Union for non-EU manufacturers placing medical devices and in vitro diagnostic devices on the market. They serve as a crucial point of contact for European authorities and Notified Bodies.
**Expertise & scope**
* Ensuring compliance with EU MDR 2017/745 and EU IVDR 2017/746.
* Verifying the availability and currency of technical documentation and EU declarations of conformity.
* Confirming that appropriate conformity assessment procedures have been undertaken.
* Managing registration obligations within the EU regulatory framework.
* Facilitating communication between competent authorities and manufacturers.
* Cooperating with authorities on preventive and corrective actions.
* Promptly informing manufacturers of complaints and suspected incidents reported by healthcare professionals, patients, and users.
* Providing competent authorities with necessary information and documentation upon request.
* Forwarding requests for device samples or access to competent authorities and verifying compliance.
**Reputation / proof points**
* The service is offered by MDRC.
Additional information
The role of an EU Authorized Representative (also known as EC REP, CE REP, EU REP, or EAR) is defined by the EU MDR and IVDR. This entity, established within the European Union, accepts a written mandate from a non-EU manufacturer to perform specific tasks. Key responsibilities include ensuring devices meet regulatory requirements and acting as the primary liaison with European regulatory bodies. The relationship and delegated tasks are formalized through a mandate agreement, a copy of which must be provided to competent authorities upon request. This ensures clear accountability and facilitates regulatory oversight for devices entering the EU market.
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 manufacturer compliance with EU MDR 2017/745 and EU IVDR 2017/746.
Source
“Both Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Medical Device Regulation (EU IVDR 2017/746) state that where a non-EU manufacturer places a device on the European market, he shall designate an Authorized Representative in the European Union.”
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Verifies 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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Cooperates with competent authorities on preventive and 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 place products on the European market
How engagement typically works
- Mandated representation
- Formal agreement required
Typical deliverables
- Regulatory compliance assurance
- Liaison with EU authorities
- Documentation verification
- Incident reporting facilitation
Good to know
- Best when the manufacturer is based outside the EU and requires a local representative.
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
Find 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, clearly defining delegated tasks. A copy of the mandate must be provided to the competent authority upon request.
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