EU Authorized Representative for medical device and IVD
MDRC
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 is a service provider that acts as a liaison between non-EU manufacturers and European authorities. They are designated to represent manufacturers placing medical devices and IVDs on the European market.
**Expertise & scope**
* Mandated to act on behalf of non-EU manufacturers for specified tasks under EU MDR (2017/745) and EU IVDR (2017/746).
* Serve as the primary point of contact for European authorities and Notified Bodies.
* Ensure compliance of devices with MDR and IVDR requirements.
* Manage communication and cooperation with competent authorities regarding preventive and corrective actions.
* Facilitate the flow of information between authorities and manufacturers, including requests for samples or device access.
* Inform manufacturers immediately about complaints and suspected incidents reported by healthcare professionals, patients, and users.
**Reputation / proof points**
* Specializes in services related to the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR).
EU Authorized Representative for medical device and IVD companies is a service provider that acts as a liaison between non-EU manufacturers and European authorities. They are designated to represent manufacturers placing medical devices and IVDs on the European market.
**Expertise & scope**
* Mandated to act on behalf of non-EU manufacturers for specified tasks under EU MDR (2017/745) and EU IVDR (2017/746).
* Serve as the primary point of contact for European authorities and Notified Bodies.
* Ensure compliance of devices with MDR and IVDR requirements.
* Manage communication and cooperation with competent authorities regarding preventive and corrective actions.
* Facilitate the flow of information between authorities and manufacturers, including requests for samples or device access.
* Inform manufacturers immediately about complaints and suspected incidents reported by healthcare professionals, patients, and users.
**Reputation / proof points**
* Specializes in services related to the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR).
Additional information
The role of an EU Authorized Representative is critical for non-EU manufacturers seeking to access the European market. This entity, also known as EC REP, CE REP, EU REP, or EAR, accepts a written mandate from the manufacturer to perform specific tasks outlined by the MDR and IVDR. Key responsibilities include ensuring the availability and currency of technical documentation and the EU Declaration of Conformity, verifying conformity assessment procedures, and managing registration obligations. They are the designated contact for competent authorities, facilitating information exchange and cooperation on regulatory matters. Manufacturers must clearly define these responsibilities in a mandate, a copy of which is provided to competent authorities upon request.
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 manufacturers comply 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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Serves as the 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.”
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
- Point of contact for EU authorities
Typical deliverables
- Ensuring technical documentation and EU Declaration of Conformity are available
- Verification of conformity assessment procedures
- Cooperation with competent authorities
- Reporting of incidents and complaints
Good to know
- Requires a written mandate clearly defining tasks
- Entity must be established within the European Union
HQ:
United States, USA
Languages:
English
Timezones:
EST
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:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
Post Market Support:
Yes
Labeling Review:
Yes
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Fsca Recall Support:
Yes
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.
