Authorized Representative

An Authorized Representative (AR), also known as EC REP (European Community Representative), is a legal entity established in the European Union that is designated by a non-EU manufacturer to act on its behalf for compliance with the EU Medical Device Regulation (MDR 2017/745). The AR serves as the regulatory interface between the manufacturer and EU authorities.

Legal requirement:
Under EU MDR Article 11, manufacturers established outside the European Union must designate an Authorized Representative who is established in the EU before placing devices on the EU market. This is a mandatory requirement - non-EU manufacturers cannot market devices in the EU without an AR.

Role and responsibilities:

The Authorized Representative's responsibilities are defined in EU MDR Article 11 and include:

Regulatory compliance interface:
- Verify that the EU Declaration of Conformity and technical documentation have been prepared
- Maintain a copy of the technical documentation and EU Declaration of Conformity at the disposal of competent authorities
- Provide competent authorities with all necessary information and documentation
- Cooperate with competent authorities on any request for information or investigation
- Inform manufacturer of complaints and reports of suspected incidents related to devices

Registration and notification:
- Register the manufacturer and devices in EUDAMED database
- Ensure the manufacturer has registered economic operators in the supply chain
- Verify device registration includes accurate UDI information
- Maintain updated registration information as manufacturer's point of contact

Post-market surveillance:
- Receive and forward vigilance reports (serious incidents, field safety corrective actions)
- Ensure manufacturer maintains post-market surveillance system
- Verify periodic safety update reports (PSUR) are submitted for implantable and Class III devices
- Coordinate with competent authorities on safety communications

Market surveillance cooperation:
- Respond to competent authority inquiries on behalf of manufacturer
- Provide access to technical documentation during inspections
- Facilitate communication between manufacturer and authorities
- Ensure manufacturer takes corrective actions when required

Important limitations:

What an AR is NOT responsible for:
- Does not replace the manufacturer's legal responsibilities
- Cannot sign the EU Declaration of Conformity on behalf of the manufacturer
- Does not conduct conformity assessment (that's the Notified Body's role)
- Not liable for defective products (manufacturer retains product liability)
- Cannot make design changes or manufacturing decisions

The manufacturer remains fully responsible for device compliance, safety, and performance. The AR is an intermediary facilitating regulatory interactions, not a substitute for the manufacturer.

Qualification requirements for Authorized Representatives:

Legal establishment:
- Must be a legal entity (company, organization) established within the EU/EEA
- Can be located in any EU member state
- Must have a physical address (not just a mailbox)
- Should maintain adequate resources and infrastructure

Expertise and competence:
- Knowledge of EU medical device regulations (MDR/IVDR)
- Understanding of post-market surveillance and vigilance requirements
- Ability to communicate effectively with competent authorities
- Language capabilities for relevant member states
- Experience with medical device regulatory affairs

Organizational capacity:
- Systems for maintaining technical documentation
- Processes for handling competent authority requests
- Vigilance reporting procedures
- EUDAMED registration and maintenance capabilities

Contractual relationship:

The manufacturer and AR must establish a written mandate (contract) that:
- Clearly defines the AR's tasks and responsibilities
- Specifies the scope of authorization (which devices covered)
- Grants AR authority to act on manufacturer's behalf for regulatory matters
- Establishes communication protocols and response timelines
- Defines document retention requirements
- Addresses termination procedures and transition planning

EU MDR Article 11 requires this mandate to empower the AR to perform specified tasks.

Difference between EU Authorized Representative and UK Responsible Person:

EU Authorized Representative (AR/EC REP):
- Required for non-EU manufacturers to market devices in EU
- Legal entity established in the EU/EEA
- Responsibilities defined by EU MDR 2017/745
- Registers devices in EUDAMED

UK Responsible Person (UKRP):
- Required for non-UK manufacturers to market devices in Great Britain after Brexit
- Legal entity established in the UK
- Responsibilities similar to EU AR but under UK MDR
- Registers devices in MHRA database

After Brexit, manufacturers may need both:
- AR for EU market access (27 EU countries + EEA)
- UKRP for Great Britain market access (England, Scotland, Wales)
- Northern Ireland follows EU MDR under Northern Ireland Protocol

Choosing an Authorized Representative:

Key selection criteria:

1. Regulatory expertise:
- Proven track record with similar device types
- Knowledge of relevant regulatory requirements
- Experience with your target EU markets
- Staff qualifications and training programs

2. Service quality:
- Responsiveness to inquiries and requests
- Quality of customer communication
- Availability during EU business hours
- Language capabilities matching your needs

3. Infrastructure and systems:
- Document management systems for technical files
- EUDAMED registration capabilities
- Vigilance reporting procedures
- IT security for confidential information

4. References and reputation:
- Client testimonials and references
- Regulatory authority relationships
- Industry reputation and longevity
- Membership in professional organizations

5. Commercial terms:
- Transparent fee structure (annual fees typically range from €2,000-€10,000+ depending on device complexity and number of devices)
- Clear scope of services included
- Additional fees for ad-hoc services
- Contract terms and termination provisions

Red flags to avoid:
- Unrealistically low prices suggesting insufficient resources
- Lack of regulatory expertise or medical device experience
- Poor communication or unresponsiveness during sales process
- Unwillingness to provide client references
- Absence of documented processes and quality systems

Changing Authorized Representatives:

Manufacturers may need to change ARs due to:
- Unsatisfactory service quality
- AR business closure or change of business
- Strategic decision to consolidate or change service providers
- Geographic realignment of regulatory support

Transition process:
- Notify competent authorities of AR change
- Update EUDAMED registration with new AR information
- Transfer technical documentation to new AR
- Ensure continuity of regulatory coverage during transition
- Update device labeling showing new AR contact information
- Notify Notified Body of change

AR contact information on labeling and documentation:

EU MDR requires devices to display AR contact information:
- AR name, registered trade name or trademark
- AR address where it can be contacted
- Information can be on device, packaging, or instructions for use
- Symbol indicating AR (specific symbol defined in MDR standards)
- Required wherever manufacturer information is displayed

Regulatory inspections and AR involvement:

When competent authorities conduct inspections or investigations:
- AR serves as point of contact and coordinator
- AR provides access to technical documentation maintained in EU
- AR facilitates communication between authority and manufacturer
- AR ensures manufacturer responds to information requests
- AR may attend inspections or meetings as manufacturer's representative

AR fees and cost considerations:

Typical AR service fees include:

Annual retainer:
- Base fee covering registration, vigilance monitoring, competent authority liaison
- Range: €2,000-€5,000 for simple Class I devices
- Range: €5,000-€15,000+ for Class IIa/IIb/III or multiple devices

Additional services:
- Technical documentation review and maintenance
- EUDAMED registration and updates
- Vigilance report submissions
- Competent authority inquiry responses
- Translation services
- Project-based consulting

Fees vary based on:
- Device classification and complexity
- Number of devices covered
- Level of support required
- Geographic coverage within EU
- AR's experience and reputation

The Authorized Representative is essential for non-EU manufacturers to access the European market, serving as the critical regulatory bridge between manufacturers and EU authorities while ensuring ongoing compliance with the Medical Device Regulation.