In the CE Marking process, appointing an Authorized Representative (EC Representative) is a legal requirement for non-EU manufacturers seeking market access. 

F&D Group provides delegation, consulting, and training services to ensure compliance with MDR (2017/745) or IVDR (2017/746) regulations.

1. Delegation Services

·       Providing Authorized Representative information on product labels, Instructions for Use (IFU), and packaging.

·       Acting as the official EU contact for non-EU manufacturers, communicating with Competent Authorities and Notified Bodies.

·       Handling EUDAMED database registration and product listing on behalf of the manufacturer.

2. Consulting Services

(1) Compliance Services for Authorized Representatives

·       Fulfilling the legal responsibilities of an official Authorized Representative in the EU.

·       Providing EU Authorized Representative information on labels, IFU, and packaging.

·       Communicating with EU Competent Authorities and Notified Bodies on behalf of the manufacturer.

·       Managing EUDAMED database registration and product listing.

·       Monitoring compliance, including Post-Market Surveillance (PMS) and market feedback management.

(2) Technical Documentation and Regulatory Support

·       Reviewing Technical Documentation to ensure MDR/IVDR compliance.

·       Assisting with the preparation and updates of Clinical Evaluation Reports (CER), Risk Management Files, and PMS/PMCF reports.

·       Providing guidance on UDI (Unique Device Identification) registration and EUDAMED listing.

·       Managing compliance changes, such as product upgrades and new regulatory adaptations.

(3) Compliance Risk Management

·       Assisting with Competent Authority inspections, market surveillance, and product recalls.

·       Handling Vigilance reporting and communicating with EU regulatory authorities.

·       Assessing compliance risks and providing improvement recommendations.

3. Training Services

(1) MDR/IVDR Regulations & Compliance Training

·       Interpretation of EU Medical Device Regulations (MDR/IVDR).

·       Overview of medical device classification and conformity assessment routes.

·       EU market access requirements and product registration processes.

(2) EU Authorized Representative Responsibilities Training

·       Legal responsibilities and obligations of an Authorized Representative.

·       Coordination with manufacturers, Notified Bodies, and Competent Authorities.

·       Ensuring continuous compliance of medical devices.

(3) Technical Documentation & Post-Market Surveillance (PMS) Training

·       How to prepare and maintain medical device Technical Documentation.

·       Requirements for PMS (Post-Market Surveillance) and PMCF (Post-Market Clinical Follow-up).

·       Handling adverse events and market surveillance procedures.

(4) EUDAMED & UDI Registration Training

·       Usage of the EUDAMED database and product registration processes.

·       Compliance requirements of the UDI (Unique Device Identification) system.