EU Authorised Representative
Acting as your EU Authorised Representative to help you meet your regulatory obligations.
Our Support Includes
- Provision of EU address for compliance
- Liaison with EU authorities
- Management of compliance communications
- Ongoing support and advice
As your EU Authorised Representative we help you:
- Meet your obligations under EU law
- Respond to requests from authorities
- Maintain access to the EU market
How the process works
Clear steps without the long scroll
Review the whole process at a glance, then expand the step that matters to you.
What we assess
The process begins with a detailed review of your organisation, machinery, and compliance arrangements.
- Machinery types and intended use
- Target EU markets
- Current CE marking status
- Existing technical documentation
- Manufacturing and supply chain arrangements
- Applicable directives and regulations
Applicable legislation may include
- Machinery Directive 2006/42/EC
- Machinery Regulation (EU) 2023/1230
- Regulation (EU) 2019/1020 on Market Surveillance
- EMC Directive
- Low Voltage Directive
- Pressure Equipment Directive
- Other product-specific legislation
This review helps determine the compliance pathway and identifies any immediate actions required before products are placed on the EU market.
Documents assessed typically include
Before accepting an Authorised Representative appointment, we conduct a comprehensive review of your compliance documentation.
- EU Declaration of Conformity
- Technical File
- Risk Assessment
- Standards Compliance Matrix
- User manuals and instructions
- CE marking and product labels
- Product traceability information
- Notified Body certificates, where applicable
- Insurance documentation
- Existing compliance procedures
The objective is to identify missing, incomplete, or outdated information and establish a clear action plan for achieving compliance.
The mandate defines
EU legislation requires a formal written mandate between the manufacturer and the Authorised Representative.
- Manufacturer details
- Authorised Representative details
- Products covered
- Applicable legislation
- Delegated responsibilities
- Communication authority with market surveillance authorities
- Technical documentation obligations
- Record retention requirements
- Duration of appointment
The mandate may also include
- Technical file retention
- Regulatory communications
- Corrective actions
- Product withdrawals
- Product recalls
- Compliance investigations
Under EU law, an Authorised Representative may only perform duties specifically delegated through this written agreement.
Typical requirements include
Prior to onboarding, manufacturers must provide a minimum compliance document package.
- Signed Authorised Representative Mandate
- EU Declaration of Conformity
- Technical File Index
- Risk Assessment
- Instruction manuals
- Standards list
- Product photographs and nameplate information
- Manufacturer registration documents
- Insurance evidence
- Technical contacts
- Recall procedure
- Technical File Retention Agreement
This documentation forms the foundation of the Authorised Representative relationship and demonstrates regulatory readiness.
Records maintained
Market surveillance authorities have the power to request compliance documentation at any time. We establish systems to ensure documentation can be produced promptly and accurately.
- Product models covered
- Technical file locations
- Product traceability information
- Market placement dates
- Retention periods
- Compliance contacts
Technical documentation is generally required to be retained for at least ten years after the final product has been placed on the market.
Technical documentation
Compliance is an ongoing responsibility rather than a one-time exercise.
- Technical file updates
- Design modifications
- Engineering changes
- Software updates
- Safety-related changes
Standards monitoring
- New harmonised standards
- Withdrawn standards
- Updated standards
- Changes affecting presumption of conformity
Compliance documentation
- Declaration of Conformity reviews
- Manual updates
- Labelling reviews
- Record retention compliance
Internal compliance audits
- Technical file completeness
- Risk assessment reviews
- Label verification
- Standards review
- Documentation control
This proactive approach helps identify potential compliance issues before they become regulatory concerns.
Product and design changes
Manufacturers must provide updated information annually or whenever significant changes occur.
- Product design changes
- Safety system modifications
- Control system changes
- Electrical changes
- Software or firmware updates
- New product models or variants
- Manufacturing process changes
Technical documentation updates
- Technical files
- Risk assessments
- Drawings and schematics
- Test reports
- Validation records
- Manuals and instructions
- Maintenance documentation
Compliance and traceability updates
- Standards currently applied, newly adopted, withdrawn, or updated
- Updated declarations when products, standards, regulations, or manufacturer details change
- Supplier evidence for safety components, electrical equipment, control systems, and critical assemblies
- Customer complaints, accidents, near misses, regulatory investigations, safety concerns, and product non-conformities
- Corrective actions, product modifications, safety notices, withdrawals, and recalls
- Product models, serial number structures, batch information, manufacturing locations, and distribution chain information
Annual confirmations
- Product liability insurance
- Professional indemnity insurance
- Compliance manager, technical, quality, regulatory, and recall contact details
- No undisclosed product changes have occurred
- Technical documentation remains accurate
- Compliance obligations continue to be met
- Relevant incidents have been reported
This review ensures products remain compliant and that documentation remains current throughout the product lifecycle.
Support may include
Should safety concerns arise, we assist manufacturers in managing compliance obligations and regulatory communications.
- Corrective and preventive actions (CAPA)
- Field modifications
- Safety notices
- Product withdrawals
- Product recalls
- Communications with authorities
- Documentation management
Prompt and effective management of these activities is essential to protecting both market access and brand reputation.