Updated: 18th July 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)
Confirm Which Economic Operators You Actually Need
Before comparing Authorised Representatives or Importers, it’s important to understand which economic operators apply to your business. One of the most common mistakes manufacturers make is assuming these roles are interchangeable when, under the Medical Device Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR), each has distinct legal responsibilities.
Choosing the correct combination of economic operators at the outset helps avoid delays during market entry, ensures regulatory responsibilities are clearly assigned and reduces the risk of compliance issues later in the product lifecycle.
New to the EU Medical Device Regulation (MDR)?
Choosing the right EU Authorised Representative or Importer is just one aspect of achieving MDR compliance. For a complete introduction to Regulation (EU) 2017/745, including device classification, Article 10 manufacturer obligations, General Safety and Performance Requirements (GSPRs), Technical Documentation, Clinical Evaluation, UDI, EUDAMED and Post-Market Surveillance, explore our EU MDR for Beginners Guide.
Manufacturing In Vitro Diagnostic Medical Devices?
The same principles apply when selecting an EU Authorised Representative for in vitro diagnostic medical devices under Regulation (EU) 2017/746 (IVDR). To learn more about IVD classification, Article 10 manufacturer obligations, Performance Evaluation, Technical Documentation, EUDAMED, Notified Bodies and ongoing compliance, explore our IVDR for Beginners Guide.
Manufacturer
The manufacturer is the natural or legal person responsible for designing, manufacturing, packaging and placing a medical device or IVD on the market under its own name or trademark. Regardless of whether certain regulatory activities are outsourced, the manufacturer always retains overall responsibility for demonstrating compliance with the MDR or IVDR.
Manufacturers are responsible for activities including:
- designing and developing compliant devices;
- preparing and maintaining Technical Documentation;
- conducting Clinical Evaluation or Performance Evaluation;
- implementing an appropriate Quality Management System (QMS);
- maintaining Post-Market Surveillance (PMS) and Vigilance activities; and
- issuing the EU Declaration of Conformity.
These responsibilities cannot be transferred to an Authorised Representative or Importer.
Understand Your Responsibilities as a Medical Device Manufacturer
Selecting the right EU Authorised Representative is only one part of achieving MDR compliance. Manufacturers remain legally responsible for meeting the obligations set out in Article 10 of Regulation (EU) 2017/745, including implementing a Quality Management System, maintaining Technical Documentation, conducting Clinical Evaluation, managing Risk Management and Post-Market Surveillance, and ensuring ongoing regulatory compliance. Learn more in our Guide to Article 10 of the EU MDR.
EU Authorised Representative
An EU Authorised Representative (EU AR) is a natural or legal person established within the European Union who has received a written mandate from a manufacturer established outside the EU to act on its behalf in relation to specific regulatory obligations.
The Authorised Representative acts as the manufacturer’s official regulatory contact within the European Union and communicates with Competent Authorities when required. However, appointing an Authorised Representative does not transfer the manufacturer’s legal responsibility for compliance.
When selecting an Authorised Representative, manufacturers should look beyond simply fulfilling a legal requirement. The organisation should have the regulatory expertise, processes and resources necessary to support ongoing compliance throughout the device’s lifecycle.
Need to Understand the Legal Responsibilities of an EU Authorised Representative?
Choosing the right EU Authorised Representative starts with understanding exactly what the role involves. Our comprehensive guide explains the legal obligations of Authorised Representatives under Article 11 of the EU MDR and IVDR, including documentation requirements, Competent Authority communications, vigilance support and ongoing regulatory responsibilities. Read our Guide to EU Authorised Representatives Under the MDR & IVDR.
Importer
An Importer is an organisation established within the European Union that places a medical device or IVD from a third country onto the Union market.
Unlike an Authorised Representative, an Importer is not appointed through a written mandate. Instead, the role is determined by the supply chain and the commercial transaction through which the device first enters the EU market.
Importers have their own regulatory obligations, including verifying that devices have undergone the appropriate conformity assessment procedures, carry CE marking where applicable and are accompanied by the required documentation and labelling before being placed on the market.
Because the Importer becomes an important part of the regulatory supply chain, manufacturers should evaluate potential Importers just as carefully as they assess prospective Authorised Representatives.
Distributor
A Distributor is any person or organisation in the supply chain, other than the manufacturer or Importer, that makes a device available on the market after it has already been placed on the market.
Distributors are responsible for exercising appropriate due care before supplying devices, including verifying that required labelling, CE marking and accompanying documentation are present. They must also cooperate with manufacturers, Importers and Competent Authorities where corrective actions or safety issues arise.
While Distributors play an important role in maintaining regulatory compliance, they should not be confused with either an Authorised Representative or an Importer.
UK Responsible Person
Manufacturers established outside Great Britain that wish to place medical devices on the GB market generally require a UK Responsible Person (UKRP).
Although the UK Responsible Person performs a role similar to that of an EU Authorised Representative, the two positions are governed by different legislation and apply to different markets. Appointing an EU Authorised Representative does not satisfy UK requirements, and appointing a UK Responsible Person does not meet EU obligations.
Manufacturers intending to market devices in both jurisdictions will often need both an EU Authorised Representative and a UK Responsible Person.
Selling Medical Devices in Great Britain?
If you're planning to market medical devices in Great Britain, you'll also need to understand the role of the UK Responsible Person (UKRP). Although the UKRP performs a similar function to an EU Authorised Representative, it is governed by different legislation and supports compliance with the UK Medical Devices Regulations 2002 (as amended). Learn more in our Complete Guide to the UK Responsible Person.
Authorised Representative vs Importer: What's the Difference?
Although both organisations form part of the European regulatory framework, they perform very different functions. Understanding these differences will help you determine which organisations you need and what criteria you should use when selecting them.
| Question | EU Authorised Representative | Importer |
|---|---|---|
| Who establishes the role? | Appointed by the non-EU manufacturer through a written mandate | Determined by the commercial supply chain when placing a device on the EU market |
| Primary purpose | Represents the manufacturer before Competent Authorities | Places devices from a third country onto the EU market |
| Legal basis | Article 11 MDR / IVDR | Article 13 MDR / IVDR |
| Must be established within the EU? | Yes | Yes |
| Appears on device labelling? | Yes | Yes, where required |
| Acts as Competent Authority contact? | Yes | Limited to their own regulatory obligations |
| Requires a written mandate? | Yes | No |
| Main selection focus | Regulatory expertise, responsiveness and compliance capability | Supply-chain controls, verification procedures and traceability |
While some organisations may perform both roles within the same supply chain, manufacturers should assess each function independently. A provider that is suitable as an Importer may not necessarily have the regulatory expertise or resources required to act as an effective Authorised Representative.
10 Essential Criteria for Choosing an EU Authorised Representative
Not all EU Authorised Representatives provide the same level of regulatory support. While every Authorised Representative must fulfil the legal obligations defined under the MDR or IVDR, the quality of their expertise, responsiveness and compliance processes can vary considerably.
Choosing an experienced and well-established Authorised Representative can help streamline market access, improve communication with Competent Authorities and reduce regulatory risk throughout the product lifecycle. Conversely, selecting an inexperienced provider may result in delayed regulatory responses, poor documentation control and unnecessary compliance issues.
When evaluating potential Authorised Representatives, consider the following criteria before signing a written mandate.
1. Is the Organisation Genuinely Established Within the European Union?
The MDR and IVDR require an EU Authorised Representative to be established within a Member State of the European Union.
Before appointment, verify that the organisation is a legitimate legal entity operating within the EU rather than simply offering a postal forwarding service or virtual address.
You should request evidence such as:
- Company registration details
- Registered office address
- VAT registration (where applicable)
- Legal entity name
- Country of establishment
A reputable Authorised Representative should have a permanent operational presence capable of responding promptly to Competent Authorities, maintaining regulatory records and supporting manufacturers throughout the lifetime of their devices.
2. Do They Have Experience With Your Device Type?
Medical devices and in vitro diagnostic medical devices cover an enormous range of technologies, risk classifications and regulatory pathways.
An organisation with extensive experience supporting Class I devices may not necessarily have the expertise required for implantable devices, software as a medical device (SaMD), sterile devices or complex in vitro diagnostics.
Ask prospective providers about their experience with:
- Medical Devices (MDR)
- In Vitro Diagnostic Medical Devices (IVDR)
- Software as a Medical Device (SaMD)
- Class I, IIa, IIb and III devices
- Class A, B, C and D IVDs
- Custom-made devices
- Sterile and measuring devices
- Combination products
A provider with experience in your specific product category is more likely to understand the practical regulatory challenges associated with your device.
3. Can They Demonstrate Strong Regulatory Expertise?
An Authorised Representative should be much more than an administrative contact within the European Union.
They should possess a thorough understanding of the regulatory framework and be able to communicate confidently with both manufacturers and Competent Authorities.
During your evaluation, consider whether the organisation has practical experience with:
- EU MDR and IVDR requirements
- Technical Documentation
- Declaration of Conformity
- Clinical Evaluation
- Performance Evaluation
- Risk Management
- Post-Market Surveillance
- Vigilance reporting
- EUDAMED registration
- CE marking requirements
A knowledgeable Authorised Representative should also be able to explain how they would manage regulatory queries or support manufacturers if compliance concerns arise.
4. Do They Have Access to an Appropriately Qualified PRRC?
Under the MDR and IVDR, Authorised Representatives are required to have permanently and continuously at their disposal at least one appropriately qualified Person Responsible for Regulatory Compliance (PRRC).
This individual helps ensure that the organisation can fulfil its regulatory obligations and respond appropriately to compliance issues.
Before appointment, ask:
- Who performs the PRRC function?
- What qualifications and regulatory experience do they have?
- Is the PRRC employed directly or contracted externally?
- How is cover provided during annual leave or staff absence?
- How is ongoing regulatory competence maintained?
A transparent provider should be able to explain how this requirement is fulfilled without hesitation.
Does Your Organisation Need a Person Responsible for Regulatory Compliance (PRRC)?
When selecting an EU Authorised Representative, it's important to understand the role of the Person Responsible for Regulatory Compliance (PRRC). Under Article 15 of the EU MDR and IVDR, manufacturers and Authorised Representatives must have permanent and continuous access to an appropriately qualified PRRC. Learn about the qualification requirements, legal responsibilities and outsourcing options in our Complete Guide to the PRRC under the EU MDR & IVDR.
5. What Does Their Onboarding Process Look Like?
A professional Authorised Representative should carry out a thorough due diligence process before accepting a manufacturer.
If a provider is willing to sign a mandate immediately without asking meaningful compliance questions or reviewing your documentation, this should raise concerns.
A robust onboarding process will typically include a review of:
- Manufacturer details
- Device portfolio
- Risk classification
- Declaration of Conformity
- Technical Documentation availability
- CE certificates (where applicable)
- Labelling and Instructions for Use
- UDI implementation
- Existing registrations
- Post-Market Surveillance arrangements
- Vigilance procedures
The objective is not to perform a conformity assessment—that remains the responsibility of the manufacturer and, where applicable, the Notified Body—but to ensure that the Authorised Representative can confidently fulfil its own regulatory obligations.
A structured onboarding process also demonstrates that the provider takes compliance seriously rather than treating the appointment as a simple administrative exercise.
6. How Will They Communicate with Competent Authorities?
One of the principal reasons for appointing an EU Authorised Representative is to establish an official point of contact within the European Union for Competent Authorities. The quality and responsiveness of this communication can have a significant impact on regulatory compliance, particularly if questions arise regarding your devices.
When evaluating a prospective Authorised Representative, ask how they manage communications with Competent Authorities and how they would support you if regulatory issues occur.
A competent provider should have documented procedures for handling:
- Requests for Technical Documentation or regulatory information
- Market surveillance enquiries
- Requests for device samples
- Compliance investigations
- Corrective and preventive actions
- Regulatory inspections
- Notifications relating to safety concerns
It is equally important to understand how these enquiries will be escalated within their organisation and how quickly you will be informed. Delays in communication can significantly affect response times and potentially increase regulatory risk.
Ask prospective providers:
- Who receives communications from Competent Authorities?
- How quickly are manufacturers notified?
- Is there a dedicated regulatory contact?
- What are the expected response times?
- Are emergency procedures available for urgent safety issues?
Choosing an Authorised Representative with experienced regulatory professionals and clearly documented communication procedures provides confidence that any regulatory enquiries will be managed efficiently and professionally.
7. How Do They Support Vigilance and Post-Market Activities?
Regulatory compliance does not end once a device has been placed on the market. Manufacturers must continually monitor device performance, investigate complaints, report serious incidents where required and implement corrective actions when necessary.
Although the manufacturer retains overall responsibility for vigilance activities, the Authorised Representative plays an important supporting role by facilitating communication with Competent Authorities and helping ensure regulatory obligations are fulfilled.
Before appointing an Authorised Representative, understand how they support ongoing post-market activities.
Topics to discuss include:
- Complaint escalation procedures
- Serious incident reporting processes
- Field Safety Corrective Actions (FSCAs)
- Field Safety Notices (FSNs)
- Communication with Competent Authorities
- Record keeping
- Post-Market Surveillance support
- Trend reporting
- Regulatory follow-up actions
An experienced Authorised Representative should have documented procedures describing how safety information is managed and communicated.
They should also be able to explain how they would coordinate with the manufacturer if a serious incident, product recall or regulatory investigation occurs.
The objective is not for the Authorised Representative to replace the manufacturer’s vigilance system, but to ensure effective communication and regulatory coordination throughout the lifecycle of the device.
Need to Understand Post-Market Surveillance Under the EU MDR?
Choosing the right EU Authorised Representative also means selecting a partner that can effectively support ongoing regulatory compliance throughout your device's lifecycle. Learn how Post-Market Surveillance (PMS), vigilance, trend reporting, PMS Plans, PMS Reports and Periodic Safety Update Reports (PSURs) help manufacturers maintain compliance with Articles 83–86 of the EU MDR in our Complete Guide to Medical Device Post-Market Surveillance.
8. How Do They Protect Your Confidential Information?
Appointing an Authorised Representative often involves providing access to commercially sensitive information, including Technical Documentation, regulatory certificates, product specifications and quality management documentation.
Manufacturers should therefore assess how prospective providers manage information security before sharing confidential regulatory documents.
Questions worth asking include:
- How is Technical Documentation stored?
- Who has access to confidential information?
- Are secure document management systems used?
- How are electronic records backed up?
- What cybersecurity measures are in place?
- How are confidentiality obligations managed?
- What happens to documentation if the mandate is terminated?
A professional Authorised Representative should have appropriate document control procedures, access restrictions and confidentiality arrangements to protect proprietary information throughout the duration of the relationship.
Where appropriate, manufacturers may also wish to review the organisation’s information security policies or certifications to gain additional confidence in their document management practices.
9. Is the Organisation Financially Stable and Able to Provide Long-Term Support?
Appointing an EU Authorised Representative is generally a long-term relationship rather than a one-off regulatory activity.
Changing Authorised Representatives can require updates to product labelling, written mandates, registrations, regulatory documentation and supply-chain records. While transfers are entirely possible, they inevitably require time and careful planning.
For this reason, manufacturers should consider the long-term stability of prospective providers.
Areas to assess include:
- Length of time in business
- Financial stability
- Professional indemnity insurance
- Regulatory experience
- Size of the regulatory team
- Business continuity arrangements
- Succession planning
- Availability of ongoing customer support
A well-established organisation with experienced regulatory professionals is generally better positioned to provide consistent support throughout the entire lifecycle of your medical devices or IVDs.
When evaluating providers, it is also worth asking how they would manage the transfer of responsibilities should either party decide to terminate the agreement in the future.
10. Are the Scope of Services and Fees Clearly Defined?
Price is naturally an important consideration when selecting an Authorised Representative, but it should never be the only deciding factor.
A low annual fee may initially appear attractive, only for manufacturers to discover later that essential regulatory activities incur additional charges.
Before signing a written mandate, ask for a detailed breakdown of what is included within the service.
The proposal should clearly define:
- Initial onboarding activities
- Annual Authorised Representative fees
- Technical Documentation reviews
- Competent Authority communications
- Vigilance support
- EUDAMED assistance
- Regulatory consultancy
- Additional hourly consultancy rates
- Charges for new devices or manufacturers
- Termination or transfer fees
The written agreement should also specify which services fall outside the standard scope of the appointment, ensuring there are no unexpected costs later in the relationship.
Rather than focusing solely on price, manufacturers should consider the overall value offered by the provider. An experienced Authorised Representative with robust regulatory expertise, effective communication processes and comprehensive support can significantly reduce compliance risks and provide long-term confidence throughout the product lifecycle.
How to Evaluate a Medical Device Importer
Selecting a suitable Importer is just as important as choosing an experienced EU Authorised Representative. Although the two roles are often mentioned together, they perform different functions within the regulatory framework and should be assessed using different criteria.
An Importer becomes the first organisation established within the European Union to place a medical device or IVD manufactured in a third country onto the Union market. As a result, Importers have specific verification responsibilities before products are made available for sale.
When evaluating a prospective Importer, manufacturers should look beyond commercial capability and consider whether the organisation has the systems, knowledge and resources required to fulfil its regulatory obligations.
Can the Organisation Legally Act as Your Importer?
Not every distributor or logistics provider automatically becomes the Importer.
The Importer is determined by the commercial supply chain and is the organisation that first places the device from a third country onto the European Union market.
Before entering into an agreement, ensure you understand:
- Who will legally act as the Importer
- Where responsibility transfers within the supply chain
- Which organisation first places the device on the EU market
- How regulatory responsibilities are allocated between the manufacturer, Authorised Representative, Importer and Distributor
Clearly defining these responsibilities at the beginning of the relationship helps avoid uncertainty later and ensures each economic operator understands its role within the supply chain.
Can They Demonstrate Robust Verification Procedures?
Before placing devices on the Union market, Importers are required to carry out a number of verification activities.
Although manufacturers remain responsible for demonstrating compliance, a competent Importer should have documented procedures that ensure appropriate checks are consistently performed before products are supplied.
When assessing an Importer, ask how they verify:
- CE marking
- EU Declaration of Conformity
- Manufacturer identification
- Authorised Representative details
- Product labelling
- Instructions for Use
- Device registration status where applicable
- UDI requirements
An experienced Importer should be able to explain their verification procedures clearly and demonstrate that they are applied consistently across all products entering the European market.
Do They Have Effective Traceability and Storage Controls?
Maintaining traceability throughout the supply chain is essential for regulatory compliance and for responding effectively if safety issues arise.
Ask prospective Importers how they manage:
- Batch, lot and serial number traceability
- Product storage conditions
- Environmental monitoring where applicable
- Stock rotation
- Distribution records
- Returns and non-conforming products
- Complaint records
- Recall support
Strong traceability systems enable manufacturers to identify affected products quickly and support efficient Field Safety Corrective Actions if required.
How Do They Manage Complaints and Safety Issues?
An Importer should have documented procedures describing how complaints and regulatory issues are managed after products have entered the European market.
Discuss how they would respond to:
- Customer complaints
- Suspected serious incidents
- Product quality concerns
- Regulatory inspections
- Requests from Competent Authorities
- Product recalls
- Field Safety Corrective Actions (FSCAs)
It is also important to understand how information is communicated back to the manufacturer and the Authorised Representative, ensuring all parties remain informed throughout any investigation.
Can They Support Long-Term Regulatory Compliance?
The relationship with an Importer should extend beyond simply bringing products into the European Union.
Manufacturers should assess whether the organisation has sufficient regulatory knowledge, operational capability and quality systems to support ongoing compliance throughout the lifecycle of the device.
Questions worth asking include:
- How are regulatory changes monitored?
- How are product updates communicated?
- What records are retained?
- How are customer complaints analysed?
- What support is provided during regulatory inspections?
- How are recalls coordinated?
- How are corrective actions managed?
Choosing an Importer with mature quality systems and a proactive approach to compliance can reduce regulatory risk and improve the resilience of your European supply chain.
Warning Signs When Choosing an Authorised Representative or Importer
Not all providers offer the same level of regulatory expertise or operational support. While competitive pricing is important, manufacturers should be cautious of organisations that appear to prioritise speed or cost over regulatory competence.
The following warning signs should prompt further investigation before entering into a written agreement.
🚩 They accept your appointment without reviewing any documentation
A reputable Authorised Representative should carry out appropriate due diligence before accepting a mandate. If no questions are asked about your devices, Technical Documentation or regulatory status, this may indicate that compliance checks are not being performed thoroughly.
🚩 They cannot clearly explain their regulatory processes
Your provider should be able to explain how they manage Competent Authority enquiries, document control, vigilance activities and regulatory communications.
Vague or inconsistent answers may indicate a lack of practical regulatory experience.
🚩 They only provide an address
An Authorised Representative should provide ongoing regulatory support rather than acting solely as a postal forwarding service.
Manufacturers should understand exactly what services are included within the appointment and how regulatory issues will be managed throughout the device lifecycle.
🚩 They cannot explain how they fulfil the PRRC requirement
Authorised Representatives are required to have permanent and continuous access to an appropriately qualified Person Responsible for Regulatory Compliance (PRRC).
A provider should be able to explain how this requirement is met and who performs the role.
🚩 There are no documented procedures
Ask whether the organisation has documented procedures covering:
- Competent Authority communications
- Complaint handling
- Vigilance support
- Document control
- Record retention
- Business continuity
Well-documented procedures are usually a good indicator of a mature regulatory organisation.
🚩 Pricing appears unusually low
Extremely low annual fees may indicate that important regulatory activities are either excluded or charged separately.
Always request a detailed breakdown of:
- Onboarding costs
- Annual fees
- Additional consultancy charges
- Registration support
- Authority communications
- Transfer fees
Understanding the full scope of the service will help avoid unexpected costs later.
🚩 They promise guaranteed regulatory approval
No Authorised Representative or Importer can guarantee regulatory approval, CE marking or the outcome of a Competent Authority investigation.
Be cautious of organisations making unrealistic claims or presenting regulatory compliance as a simple administrative exercise.
Questions to Ask Before Appointing an EU Authorised Representative or Importer
Selecting an Authorised Representative or Importer should involve more than reviewing a quotation or comparing annual fees. Before entering into a formal agreement, manufacturers should carry out their own due diligence to ensure the organisation has the experience, resources and regulatory processes needed to support long-term compliance.
The following questions can help you compare prospective providers objectively and identify potential risks before signing a contract.
Questions to Ask an EU Authorised Representative
When speaking with a prospective Authorised Representative, consider asking:
- How long have you been acting as an EU Authorised Representative?
- Do you support manufacturers operating under both the MDR and IVDR?
- What experience do you have with devices similar to ours?
- What information do you review before accepting a written mandate?
- How do you manage communications with Competent Authorities?
- How are urgent regulatory enquiries handled outside normal business hours?
- Who performs your Person Responsible for Regulatory Compliance (PRRC) function?
- How do you maintain access to regulatory documentation throughout the lifetime of the device?
- What support do you provide during vigilance investigations or Field Safety Corrective Actions?
- How do you protect confidential Technical Documentation and commercially sensitive information?
- What services are included within your annual fee?
- How would the transfer to another Authorised Representative be managed if required?
A knowledgeable Authorised Representative should be able to answer these questions clearly and provide supporting documentation where appropriate.
Questions to Ask a Medical Device Importer
Importers should also be evaluated carefully, particularly where they will become an important part of your European supply chain.
Questions to consider include:
- How do you verify compliance before placing devices on the EU market?
- What checks do you perform on CE marking, labelling and accompanying documentation?
- How do you maintain traceability throughout your supply chain?
- How are complaints recorded and investigated?
- What procedures do you have for supporting product recalls or Field Safety Corrective Actions?
- How are storage and transportation conditions controlled?
- How do you communicate regulatory issues to manufacturers and Authorised Representatives?
- What records are retained to demonstrate ongoing compliance?
The answers to these questions will provide valuable insight into the maturity of the Importer’s quality system and its ability to support regulatory compliance.
Documents You Should Review Before Signing an Agreement
A reputable Authorised Representative or Importer should be willing to provide appropriate documentation to support your due diligence process.
Reviewing these documents before appointment helps ensure you understand exactly what services are being provided and how regulatory responsibilities will be managed.
| Document | Why It Matters |
|---|---|
| Written Mandate (Authorised Representative) | Defines the legal responsibilities of both parties and the scope of the appointment. |
| Service Agreement or Contract | Explains the services included, exclusions, fees and termination arrangements. |
| Company Registration Details | Confirms the legal entity and country of establishment. |
| Professional Indemnity Insurance | Demonstrates financial protection and risk management. |
| PRRC Arrangements | Provides confidence that regulatory compliance responsibilities are appropriately supported. |
| Confidentiality or Non-Disclosure Agreement | Protects commercially sensitive information and Technical Documentation. |
| Complaint and Vigilance Procedures | Demonstrates how regulatory issues will be managed and escalated. |
| Business Continuity Arrangements | Provides assurance that services can continue during unforeseen disruptions. |
| Information Security Procedures | Explains how confidential documentation is stored, protected and accessed. |
| References or Relevant Experience | Helps demonstrate competence within your device category or regulatory pathway. |
Reviewing this information before signing an agreement can significantly reduce the risk of appointing an unsuitable regulatory partner.
Reviewing the Written Mandate
The written mandate is one of the most important documents governing the relationship between a manufacturer and its EU Authorised Representative. Rather than viewing it as a standard contract, manufacturers should carefully review its contents to ensure responsibilities are clearly defined and aligned with regulatory requirements.
Before signing, consider whether the agreement clearly explains:
- The devices and manufacturers covered by the appointment
- The regulatory responsibilities of each party
- The process for communicating with Competent Authorities
- How requests for Technical Documentation will be managed
- Confidentiality obligations
- Vigilance and post-market communication procedures
- Service limitations and exclusions
- Fee structure and additional chargeable services
- Liability provisions
- Circumstances under which the mandate may be terminated
- Arrangements for transferring responsibilities to another Authorised Representative
If any aspect of the agreement is unclear, seek clarification before signing. A well-written mandate should leave both parties with a clear understanding of their respective responsibilities and establish a strong foundation for a long-term regulatory partnership.
Comparing Potential Providers
Once you’ve completed your due diligence, it can be helpful to compare prospective providers using a structured assessment rather than relying solely on cost.
The following example scorecard provides a simple way to evaluate each organisation against the factors most likely to influence long-term regulatory success.
| Assessment Area | Suggested Weighting |
|---|---|
| Regulatory knowledge and experience | 20% |
| Experience with your device type | 15% |
| Onboarding and due diligence process | 15% |
| Competent Authority communication | 10% |
| Vigilance and post-market support | 10% |
| Information security and document management | 10% |
| Business continuity and financial stability | 10% |
| Customer support and responsiveness | 5% |
| Transparency of fees and contract terms | 5% |
While every manufacturer’s priorities will differ, regulatory competence and operational capability should generally carry greater weight than price alone. Selecting the lowest-cost provider may prove significantly more expensive if compliance issues arise later in the product lifecycle.
Appointing Your EU Authorised Representative or Importer
Once you have completed your due diligence and selected a suitable regulatory partner, the appointment process should be carefully planned to ensure a smooth transition and minimise disruption to your European market access.
Although every manufacturer’s circumstances will differ, the process generally follows the same sequence of steps.
Step 1 – Identify Your Regulatory Requirements
Confirm which economic operators are required for your products and intended markets.
This may include:
- EU Authorised Representative
- Importer
- UK Responsible Person
- Distributor
Understanding your regulatory obligations at the outset will help avoid unnecessary delays later in the process.
Step 2 – Complete Due Diligence
Evaluate prospective providers using the criteria discussed throughout this guide.
Review their:
- Regulatory expertise
- Device experience
- Quality systems
- Communication processes
- Business continuity arrangements
- Contractual terms
Do not make a decision based solely on price.
Step 3 – Review and Sign the Written Agreement
Once a preferred provider has been selected, carefully review the written mandate and any associated service agreements.
Ensure both parties clearly understand:
- Scope of services
- Responsibilities
- Communication arrangements
- Fees
- Confidentiality obligations
- Termination provisions
Any questions should be resolved before the agreement is signed.
Step 4 – Supply Regulatory Documentation
Your Authorised Representative will normally request access to key regulatory documents required to fulfil their responsibilities.
Depending on the device, this may include:
- EU Declaration of Conformity
- Technical Documentation
- CE certificates (where applicable)
- Product labelling
- Instructions for Use
- Manufacturer contact details
- Quality Management System information
Providing complete and accurate documentation at the beginning of the relationship helps ensure efficient ongoing support.
Step 5 – Update Registrations and Product Information
Once the appointment is complete, you may need to update various regulatory records and product information.
This can include:
- Device labelling
- Instructions for Use
- Registration records
- Supply-chain documentation
- Internal quality procedures
The exact activities will depend on your products, conformity assessment route and applicable legislation.
Step 6 – Maintain an Ongoing Regulatory Partnership
Appointing an Authorised Representative should be viewed as the beginning of an ongoing regulatory relationship rather than the completion of a one-off administrative task.
Manufacturers should continue to:
- Keep documentation up to date
- Notify significant changes
- Maintain effective communication
- Share relevant post-market information
- Review the relationship periodically
A collaborative approach helps ensure both parties remain prepared for regulatory inspections, vigilance activities and future legislative changes.
Common Misconceptions About Choosing an Authorised Representative or Importer
Manufacturers frequently encounter conflicting information when selecting regulatory partners. The following are some of the most common misconceptions.
Does the cheapest Authorised Representative provide the best value?
Not necessarily.
While cost is an important consideration, manufacturers should also evaluate regulatory expertise, responsiveness, communication processes and the scope of services included. A provider with a slightly higher annual fee may offer significantly greater support and reduce compliance risks over the lifetime of the device.
Can I appoint more than one EU Authorised Representative?
Generally, no.
A manufacturer should appoint a single EU Authorised Representative for the devices covered by the written mandate. Appointing multiple representatives for the same devices can create uncertainty regarding regulatory responsibilities and communications with Competent Authorities.
Can my Importer also act as my EU Authorised Representative?
Sometimes.
In certain supply-chain arrangements, the same legal entity may perform both roles, provided all applicable legal requirements are met. However, manufacturers should carefully assess whether the organisation has the expertise, resources and procedures necessary to fulfil both sets of responsibilities effectively.
Do I need to change my product labelling after appointing an Authorised Representative?
Usually, yes.
Where an EU Authorised Representative is required, their name and address generally need to appear on the device, packaging or accompanying documentation in accordance with the applicable regulatory requirements.
Manufacturers should ensure that labelling updates are completed before placing products on the European market.
Once appointed, can I simply leave compliance to my Authorised Representative?
No.
The manufacturer always remains legally responsible for demonstrating compliance with the MDR or IVDR. An Authorised Representative supports the manufacturer in fulfilling specific regulatory obligations but does not become the legal manufacturer or assume overall responsibility for the device.
Frequently Asked Questions (FAQs) Choosing an Authorised Representative or Importer
The appointment process varies depending on the complexity of the devices and the quality of the documentation provided. Manufacturers with well-prepared regulatory documentation can often complete the onboarding process much more quickly than those requiring significant compliance support.
Yes. Manufacturers may appoint a different Authorised Representative if circumstances change. However, the transition should be carefully managed to ensure documentation, registrations and product labelling remain accurate throughout the process.
The relationship should be reviewed periodically, particularly following significant regulatory changes, organisational restructuring or changes to the manufacturer’s product portfolio.
Many organisations support manufacturers under both Regulations, although manufacturers should confirm that the provider has appropriate expertise in the specific product types concerned.
Many manufacturers include their Authorised Representative within their supplier management programme and periodically review their performance as part of ongoing quality management activities.
Not necessarily. Whether an Importer is required depends on how products enter the European Union and the structure of the supply chain. Manufacturers should understand how their commercial arrangements determine which organisation assumes the Importer role.
Conclusion
Selecting an EU Authorised Representative or Importer is a strategic regulatory decision that extends far beyond meeting a legal requirement. The organisations you appoint become key participants in your European regulatory framework and can have a significant influence on market access, regulatory communications and long-term compliance.
Rather than focusing solely on annual fees, manufacturers should assess regulatory expertise, operational capability, communication processes and the provider’s ability to support them throughout the entire product lifecycle.
By carrying out thorough due diligence, reviewing contractual arrangements carefully and establishing a collaborative working relationship from the outset, manufacturers can significantly reduce regulatory risk and build a strong foundation for successful market access within the European Union.
References
This guide is based on the following legislation and official regulatory guidance relating to the appointment of Authorised Representatives, Importers and other economic operators under the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/745 on Medical Devices (MDR) | Contains Article 11 and Articles 13–14, establishing the legal responsibilities of Authorised Representatives, importers and distributors for medical devices placed on the European Union market. |
| European Union | Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) | Establishes equivalent requirements for Authorised Representatives, importers and distributors placing in vitro diagnostic medical devices on the European Union market. |
| European Commission | Authorised Representatives, Importers and Distributors | Provides official European Commission guidance explaining the legal roles, responsibilities and obligations of Authorised Representatives, importers and distributors under the MDR and IVDR. |
| European Commission | Economic Operators | Explains the responsibilities of manufacturers, Authorised Representatives, importers and distributors, supporting the discussion of selecting competent regulatory partners. |
| European Commission | EUDAMED Actor Registration Module | Provides official guidance on the registration of manufacturers, Authorised Representatives and other economic operators within EUDAMED, including the allocation of Single Registration Numbers (SRNs). |
Choosing an Authorised Representative or Importer is a significant regulatory decision. Manufacturers should always consult the latest published legislation and official guidance when appointing economic operators and ensuring continued compliance under the MDR and IVDR.
Patient Guards Recent Posts
Cosmetic Product Safety Report (CPSR): A Complete Guide to UK Cosmetic Compliance
Before a cosmetic product can legally be placed on the UK market, manufacturers and Responsible Persons must demonstrate that it is safe for human use under normal or reasonably foreseeable conditions. The Cosmetic Product Safety Report (CPSR) is one of the most important regulatory documents required under the UK Cosmetics Regulation. This guide explains what a CPSR is, who can prepare one, what information it must contain, how it relates to the Product Information File (PIF) and how it supports legal cosmetic compliance.
IVDR PMPF Explained: A Complete Guide to Post-Market Performance Follow-up
Post-Market Performance Follow-up (PMPF) is a fundamental requirement under the EU In Vitro Diagnostic Regulation (IVDR), ensuring that manufacturers continually monitor the scientific validity, analytical performance and clinical performance of their in vitro diagnostic medical devices after CE marking. This guide explains IVDR PMPF requirements, PMPF Plans, PMPF Reports, Annex XIII expectations and how ongoing performance monitoring supports continued regulatory compliance throughout the device lifecycle.
IVDR Scientific Validity Explained: A Complete Guide for Manufacturers
Scientific Validity is the first pillar of IVDR Performance Evaluation and provides the scientific foundation demonstrating that an analyte or biomarker is associated with a specific clinical condition or physiological state. This guide explains Scientific Validity under Regulation (EU) 2017/746, including literature reviews, Scientific Validity Reports, Annex XIII requirements, evidence appraisal and how Scientific Validity supports successful CE marking.
Patient Guards Related Services
Patient Guards Regulatory Tools
Need Training?
Do you need training on Quality Management Systems or EU MDR/ EU IVDR? then check out our training courses.
