Medical Device Manufacturer - Authorized Representative Mandate - EU
Medical Device Manufacturer - Authorized Representative Mandate - EU
Template Overview
Template Overview
If you are a non-EU medical device manufacturer, you must appoint an EU Authorised Representative (EC-REP) to comply with Medical Device Regulation (MDR) 2017/745. Our EU MDR Authorised Representative Mandate Template provides a legally compliant agreement format, ensuring a clear and structured relationship between the manufacturer and their EU representative.
Key Features
Key Features
✔ Pre-Formatted Mandate Agreement – Covers all MDR Article 11 requirements.
✔ Roles & Responsibilities Defined – Clearly outlines obligations for both parties.
✔ Regulatory Compliance Commitments – Ensures adherence to EU MDR requirements.
✔ Product Liability & Vigilance Reporting – Establishes responsibilities for post-market surveillance.
✔ UDI & Labeling Requirements – Ensures compliance with EU product marking obligations.
✔ Customizable & Legally Sound Format – Editable for different device classifications and business needs.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use mandate template helps manufacturers and authorised representatives establish a legally compliant agreement, ensuring smooth market entry and ongoing MDR compliance.
Get your EU MDR Authorised Representative Mandate Template today and confidently secure your EC-REP partnership for European market access!
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Additional information
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About Patient Guard
QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.
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Contact Us
For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.