Introduction

For medical device manufacturers established outside the European Union, entering the European market involves more than obtaining CE marking. One of the first regulatory requirements is the appointment of an EU Authorised Representative (EU AR).

Many manufacturers initially assume that the Authorised Representative is simply a company whose name and address appear on the product label. In reality, the role is far more significant under the Medical Device Regulation (EU) 2017/745 (EU MDR). The regulation has expanded the responsibilities of the EU Authorised Representative, making it an important part of the regulatory framework for medical devices placed on the European market.

The EU Authorised Representative acts as the manufacturer’s official point of contact within the European Union. Competent Authorities, customs authorities, importers and other regulatory stakeholders rely on the Authorised Representative whenever information about a device or its compliance is required. This is particularly important when the manufacturer is located thousands of kilometres away and cannot respond quickly to regulatory requests.

Although the Authorised Representative performs several important regulatory functions, it is equally important to understand what the representative is not responsible for. Appointing an EU Authorised Representative does not transfer the manufacturer’s obligations under the MDR. The manufacturer remains fully responsible for designing, manufacturing, testing, documenting and monitoring the safety and performance of its medical devices.

Choosing an experienced and competent Authorised Representative is therefore more than a regulatory requirement—it is an important business decision. A knowledgeable representative can help manufacturers respond efficiently to regulatory enquiries, support market surveillance activities, and maintain compliance throughout the product lifecycle.

This article explains the role of the EU Authorised Representative under EU MDR 2017/745, including the responsibilities defined in Article 11, the process for changing an Authorised Representative under Article 12, and the requirement for a Person Responsible for Regulatory Compliance (PRRC) under Article 15. It also discusses practical considerations that manufacturers should keep in mind when selecting and working with an EU Authorised Representative.

What is an EU Authorised Representative?

An EU Authorised Representative is a natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer located outside the Union to act on the manufacturer’s behalf for specified regulatory tasks.

Simply put, the EU Authorised Representative serves as the manufacturer’s official regulatory representative within the European Union.

The relationship between the manufacturer and the Authorised Representative is governed by a written mandate. This document defines the regulatory activities that the representative is authorised to perform and establishes the responsibilities of both parties.

One common misconception is that the Authorised Representative becomes the legal manufacturer. This is not correct.

The manufacturer continues to be responsible for:

Designing and manufacturing the medical device.
Establishing and maintaining the Quality Management System.
Preparing Technical Documentation.
Conducting Risk Management and Clinical Evaluation.
Meeting the General Safety and Performance Requirements (GSPRs).
Performing Post-Market Surveillance and Vigilance activities.
Demonstrating compliance with the MDR.

The Authorised Representative supports specific regulatory activities on behalf of the manufacturer but does not assume ownership of the device or responsibility for its design and manufacture.

Who Needs an EU Authorised Representative?

Article 11 of the MDR requires manufacturers established outside the European Union to appoint a sole Authorised Representative before placing a device on the Union market.

This requirement applies regardless of where the manufacturer is located. Whether the company is based in India, the United States, the United Kingdom, Canada, Australia, Japan, South Korea or any other non-EU country, an EU Authorised Representative must be appointed before the device can be legally marketed in the European Union.

The requirement also applies irrespective of the sales model. Even if products are supplied through distributors, importers or online channels, the manufacturer must have an appointed EU Authorised Representative.

Manufacturers occasionally ask whether establishing a sales office or appointing a distributor in Europe eliminates this requirement. In most cases, it does not. Unless the manufacturer itself is established within the European Union, an EU Authorised Representative remains mandatory.

Why Did the MDR Strengthen the Role of the EU Authorised Representative?

Under the previous Medical Device Directive (MDD), the Authorised Representative was often viewed primarily as an administrative contact. Their role typically involved maintaining certain documentation and acting as a communication channel between the manufacturer and Competent Authorities.

The MDR has taken a different approach.

The European Commission recognised that effective regulatory oversight requires a knowledgeable contact established within the European Union who can respond promptly when safety or compliance issues arise. If a Competent Authority needs access to Technical Documentation, requests information about a device, or initiates a market surveillance activity, there must be someone within the Union who can coordinate with the manufacturer without unnecessary delay.

For this reason, the MDR assigns additional responsibilities to the Authorised Representative, including verification of specific regulatory documentation, cooperation with Competent Authorities, support during market surveillance activities, and communication regarding complaints and incidents.

These changes do not reduce the manufacturer’s responsibilities. Instead, they strengthen the regulatory framework by ensuring that there is an accountable representative within the European Union who can support regulatory authorities whenever required.

Appointing an EU Authorised Representative

The appointment of an EU Authorised Representative is not simply a commercial arrangement. It is a legal requirement governed by Article 11 of the MDR.

The manufacturer must appoint the representative through a written mandate, and the appointment becomes effective only when the Authorised Representative formally accepts the mandate.

The written mandate should clearly identify:

The manufacturer and the Authorised Representative.
The devices covered by the mandate.
The responsibilities delegated to the Authorised Representative.
Communication procedures.
Documentation requirements.
Complaint handling arrangements.
Confidentiality obligations.
Conditions for terminating the agreement.

In practice, the written mandate is one of the first documents that may be reviewed during regulatory inspections or audits. A well-prepared agreement helps avoid misunderstandings and clearly establishes the responsibilities of both parties.

It is also important to note that a manufacturer may appoint only one Authorised Representative for a particular generic device group. Appointing multiple representatives for the same group of devices is not permitted under the MDR.

Responsibilities of the EU Authorised Representative

Article 11 of the MDR specifies the minimum responsibilities of an EU Authorised Representative. These responsibilities cannot be removed from the written mandate and apply to every Authorised Representative acting on behalf of a non-EU manufacturer.

The role extends well beyond providing a European address. An EU Authorised Representative is expected to actively support regulatory compliance throughout the lifecycle of the device.

The key responsibilities include:

Verifying Regulatory Documentation

Before acting on behalf of the manufacturer, the Authorised Representative should verify that:

The EU Declaration of Conformity has been prepared.
Technical Documentation has been compiled.
The appropriate conformity assessment procedure has been completed, where applicable.

This verification does not mean that the Authorised Representative is responsible for preparing or approving these documents. Those responsibilities remain with the manufacturer. The purpose is to confirm that the required documentation exists before devices are placed on the market.

Maintaining Regulatory Documentation

The Authorised Representative must keep available copies of key regulatory documents, including:

Technical Documentation.
EU Declaration of Conformity.
CE certificates issued by the Notified Body, where applicable.

These documents must be available to Competent Authorities upon request and retained for the period specified under the MDR.

Supporting Registration Requirements

The Authorised Representative is also involved in registration-related activities. This includes registering its own details in EUDAMED and verifying that the manufacturer has fulfilled applicable registration obligations before devices are placed on the market.

While the representative verifies these obligations, responsibility for the accuracy of the information remains with the manufacturer.

Acting as the Regulatory Contact

One of the most visible responsibilities of the Authorised Representative is serving as the primary regulatory contact within the European Union.

Competent Authorities may communicate directly with the representative to request documentation, clarify regulatory matters, or seek information during market surveillance activities. The Authorised Representative is expected to respond promptly and coordinate with the manufacturer whenever necessary.

Supporting Competent Authorities

One of the key reasons for appointing an EU Authorised Representative is to ensure that Competent Authorities have a reliable regulatory contact within the European Union.

During the lifetime of a medical device, authorities may request additional information for various reasons. These requests could arise during routine market surveillance, following a customer complaint, after a serious incident has been reported, or as part of an investigation into a potential safety concern.

When such requests are received, the EU Authorised Representative is expected to respond without unnecessary delay. Depending on the nature of the request, the representative may need to provide copies of regulatory documentation, coordinate with the manufacturer to obtain additional information, or facilitate communication between the manufacturer and the relevant Competent Authority.

Although the representative acts as the primary contact within the EU, the technical information generally originates from the manufacturer. Maintaining good communication between both parties is therefore essential. Delays in sharing information or outdated documentation can quickly become a regulatory issue during inspections or investigations.

Cooperation During Market Surveillance

Medical devices do not stop being regulated once they receive CE marking. In fact, a significant part of regulatory oversight takes place after the device has entered the market.

Competent Authorities regularly conduct market surveillance activities to verify that devices continue to comply with the MDR. These activities may include reviewing technical documentation, requesting additional evidence, investigating complaints, or assessing corrective actions implemented by the manufacturer.

The EU Authorised Representative plays an important supporting role during these activities.

For example, if a Competent Authority requests copies of the Declaration of Conformity, CE certificate, or other regulatory documents, the Authorised Representative should be able to provide them promptly. Similarly, if additional technical information is required from the manufacturer, the representative is expected to coordinate communication and help ensure that responses are submitted within the requested timelines.

An organised document management system and regular communication between the manufacturer and the Authorised Representative can make these interactions significantly smoother.

Complaint Handling and Vigilance

No manufacturer expects complaints or adverse events to occur, but every manufacturer must be prepared to manage them.

Under the MDR, the Authorised Representative has specific responsibilities when complaints or reports relating to a device are received.

If a healthcare professional, distributor, patient or user contacts the Authorised Representative regarding a suspected incident involving a device covered by its mandate, the representative should promptly inform the manufacturer. This allows the manufacturer to evaluate the event and determine whether it is reportable under the MDR vigilance requirements.

It is important to understand that the Authorised Representative does not investigate the complaint or decide whether the incident is reportable. Those responsibilities remain with the manufacturer.

However, timely communication is critical. Delays in forwarding complaints could affect the manufacturer’s ability to meet the reporting timelines specified in the MDR.

For this reason, manufacturers should establish clear internal procedures describing how complaints received by the Authorised Representative will be communicated, investigated and documented.

Cooperation During Corrective Actions

There may be situations where a manufacturer needs to implement corrective actions after a device has been placed on the market.

Examples include:

Product recalls.
Field Safety Corrective Actions (FSCAs).
Field Safety Notices (FSNs).
Safety-related software updates.
Corrective actions following a Competent Authority investigation.

The EU Authorised Representative supports these activities by maintaining communication with Competent Authorities and assisting with regulatory coordination where required.

Although the manufacturer remains responsible for planning and implementing corrective actions, having an experienced Authorised Representative often helps ensure that communication with regulators is timely and well coordinated.

Responsibilities That Remain with the Manufacturer

A common misconception among first-time manufacturers is that appointing an EU Authorised Representative transfers regulatory responsibility to the representative.

This is not the case.

Article 11 clearly states that the written mandate cannot delegate the manufacturer’s obligations under Article 10 of the MDR.

The manufacturer remains fully responsible for all activities related to the safety, performance and compliance of the device.

These responsibilities include:

Device design and development.
Manufacturing and process control.
Quality Management System.
Risk Management.
Clinical Evaluation.
Performance evaluation, where applicable.
Technical Documentation.
Post-Market Surveillance.
Vigilance reporting.
Regulatory compliance throughout the product lifecycle.

The Authorised Representative may support certain regulatory activities, but it cannot replace the manufacturer or assume responsibility for compliance.

This distinction is particularly important during audits and inspections. Competent Authorities expect manufacturers to understand and fulfil their own regulatory obligations rather than relying entirely on their Authorised Representative.

Legal Liability of the EU Authorised Representative

One of the most significant changes introduced by the MDR is the increased legal responsibility of the EU Authorised Representative.

Under Article 11(5), if a manufacturer established outside the European Union fails to meet its obligations under the MDR, the Authorised Representative may become jointly and severally liable for defective devices under certain circumstances.

This provision has changed the way many Authorised Representatives evaluate prospective clients.

Today, most reputable representatives perform regulatory due diligence before accepting a new manufacturer. Rather than simply signing a service agreement, they may request documents such as:

ISO 13485 certificate.
Technical Documentation.
Declaration of Conformity.
CE certificates.
Risk Management File.
Clinical Evaluation Report.
Post-Market Surveillance procedures.
Vigilance procedures.

This review helps the representative understand the manufacturer’s level of regulatory maturity and identify potential compliance gaps before entering into a mandate.
Manufacturers should therefore be prepared for a detailed onboarding process rather than expecting immediate acceptance.

A Practical Example

Consider an Indian manufacturer developing a patient monitoring device for the European market.

The company has completed product development, implemented an ISO 13485 Quality Management System and obtained CE certification through a Notified Body.

Before placing the device on the European market, the manufacturer appoints an EU Authorised Representative established in Germany.

If a Competent Authority in France later requests additional information about the device, it will normally contact the Authorised Representative first. The representative will review the request, coordinate with the manufacturer, obtain the necessary information, and submit the response within the required timeline.

Similarly, if a complaint is received from a hospital in Italy regarding the device, the Authorised Representative should promptly inform the manufacturer so that the complaint can be evaluated through the manufacturer’s vigilance process.

This example illustrates how the Authorised Representative supports regulatory communication while the manufacturer remains responsible for technical decisions and regulatory compliance.

Common Misconceptions

Several misconceptions about the role of an EU Authorised Representative continue to circulate within the industry.

One of the most common is that the Authorised Representative is responsible for obtaining CE marking. In reality, CE marking remains the manufacturer’s responsibility.

Another misconception is that the Authorised Representative prepares the Technical Documentation. The representative verifies that the required documentation exists and maintains access to it, but preparation and maintenance remain the manufacturer’s responsibility.

Some manufacturers also believe that appointing an Authorised Representative transfers legal responsibility for the device. While the representative has defined regulatory responsibilities and potential liability under certain circumstances, the manufacturer continues to bear primary responsibility for complying with the MDR.

Understanding these distinctions helps manufacturers establish realistic expectations and build an effective working relationship with their Authorised Representative.

Changing an EU Authorised Representative

There may be situations where a manufacturer decides to change its EU Authorised Representative. This could be due to changes in business strategy, service quality, commercial agreements, mergers, acquisitions, or simply because the manufacturer has identified a representative with greater regulatory expertise.

Whatever the reason, changing an Authorised Representative is not as simple as terminating one contract and signing another.

Article 12 of the MDR establishes a structured process to ensure that regulatory responsibilities are transferred in an orderly manner without affecting compliance or disrupting the availability of medical devices on the European market.

The objective is straightforward: throughout the transition, there should always be clarity about who is acting as the manufacturer’s authorised representative and who is responsible for regulatory communication within the European Union.

A Written Transition Agreement is Essential

When changing an EU Authorised Representative, the MDR requires a written agreement between the parties involved. Wherever practicable, this agreement should involve:

The manufacturer
The outgoing Authorised Representative
The incoming Authorised Representative

Although the manufacturer initiates the change, all parties should clearly understand their responsibilities during the transition period.

A well-prepared transition agreement helps avoid gaps in communication with Competent Authorities and ensures that important regulatory information is not lost during the handover.

What Should the Transition Agreement Cover?

The MDR specifies several areas that should be addressed when changing an Authorised Representative.

Effective Dates

The agreement should clearly define:

The date on which the outgoing Authorised Representative ceases to act on behalf of the manufacturer.
The date on which the incoming Authorised Representative officially assumes responsibility.

Having clearly defined dates avoids confusion, particularly if a Competent Authority contacts the representative during the transition period.

Transfer of Regulatory Documentation

One of the most important aspects of the transition is the transfer of regulatory documentation.

Depending on the agreement, this may include:

EU Declaration of Conformity.
Technical Documentation.
CE certificates.
Regulatory correspondence.
Complaint records.
Vigilance communications.
Previous inspection records.
Other documents relevant to the manufacturer’s compliance.

The outgoing Authorised Representative should ensure that confidential information is handled appropriately throughout the transfer process.

Product Labels and Instructions for Use

Changing an Authorised Representative also affects product labelling.

Since the Authorised Representative’s name and address appear on device labels and Instructions for Use (IFUs), manufacturers need a plan for updating these materials.

In practice, this often happens during the next scheduled production run to minimise unnecessary waste. However, manufacturers should ensure that the transition is managed within the timelines agreed by all parties and in accordance with regulatory requirements.

Complaints Received After the Transition

Even after the mandate has ended, the outgoing Authorised Representative may still receive complaints relating to devices previously covered under its mandate.

The MDR expects such complaints to be forwarded promptly to either:

The manufacturer, or
The incoming Authorised Representative.

This helps ensure that vigilance activities continue without interruption.

Planning Ahead Makes the Transition Easier

From a practical perspective, manufacturers should avoid changing an Authorised Representative during major regulatory activities whenever possible.

For example, changing representatives while:

undergoing a Notified Body audit,
responding to a Competent Authority investigation,
managing a Field Safety Corrective Action,
or preparing for a significant product launch,

can introduce unnecessary complexity.

If a change is unavoidable, careful planning and close communication between all parties become even more important.

Person Responsible for Regulatory Compliance (PRRC)

Another significant change introduced by the MDR is the requirement for a Person Responsible for Regulatory Compliance (PRRC).

Most regulatory professionals associate the PRRC requirement with manufacturers. However, Article 15 also requires every EU Authorised Representative to have at least one qualified PRRC permanently and continuously at its disposal.

This reflects the increased regulatory responsibilities assigned to Authorised Representatives under the MDR.

Why Does an Authorised Representative Need a PRRC?

Today’s EU Authorised Representative performs far more than administrative activities.

The representative may need to:

Review regulatory documentation before accepting representation.
Respond to Competent Authorities.
Support market surveillance activities.
Coordinate complaint handling.
Assist during vigilance investigations.
Verify regulatory obligations before devices are placed on the market.

These activities require individuals with appropriate regulatory knowledge and experience.

The PRRC helps ensure that these responsibilities are carried out consistently and in accordance with the MDR.

Qualification Requirements

Article 15 provides two pathways for qualifying as a PRRC.

Option 1 – Academic Qualification and Experience

An individual qualifies if they possess:

A university degree (or equivalent qualification) in law, medicine, pharmacy, engineering, or another relevant scientific discipline,

together with

At least one year of professional experience in medical device regulatory affairs or Quality Management Systems relating to medical devices.

Option 2 – Professional Experience

Where the required academic qualification is not available, an individual may qualify through professional experience alone.

In this case, the individual must demonstrate at least four years of professional experience in medical device regulatory affairs or medical device Quality Management Systems.

This pathway recognises that extensive practical experience can provide the necessary regulatory competence.

“Permanently and Continuously Available”

One phrase in Article 15 often raises questions.

The regulation states that the PRRC must be “permanently and continuously at the disposal” of the Authorised Representative.

This does not necessarily mean the PRRC must be a full-time employee.

What matters is that the Authorised Representative has reliable access to qualified regulatory expertise whenever required.

Many organisations achieve this through employment, while others use long-term contractual arrangements.

Regardless of the organisational structure, the expectation remains the same—the PRRC must be available whenever regulatory decisions or interactions require their expertise.

Can the Manufacturer and Authorised Representative Share the Same PRRC?

This is another question frequently asked by manufacturers.

In general, the PRRC responsible for the manufacturer and the PRRC supporting the Authorised Representative should be different individuals.

The intention is to maintain independent regulatory oversight and avoid conflicts of interest.

Each organisation has its own regulatory responsibilities under the MDR, and each should have appropriate regulatory expertise available to fulfil those responsibilities.

Selecting the Right EU Authorised Representative

For many manufacturers, cost is the primary consideration when selecting an Authorised Representative.

In reality, the representative becomes one of the manufacturer’s closest regulatory partners in Europe. Choosing solely on price can lead to difficulties later.

Before appointing an Authorised Representative, manufacturers should consider several factors.

Regulatory Experience

Does the representative have experience with devices similar to yours?

An organisation familiar with software medical devices may not necessarily have the same level of expertise in implantable devices or in vitro diagnostics.

Technical Capability

Can the representative understand your product and communicate effectively with Competent Authorities if technical questions arise?

A representative with experienced regulatory professionals is often better equipped to support manufacturers during inspections and investigations.

Responsiveness

Regulatory timelines can be tight, particularly when dealing with serious incidents or Competent Authority requests.

Manufacturers should understand how quickly the representative typically responds to regulatory enquiries and whether clear communication channels are established.

Knowledge of Current Regulations

The MDR continues to evolve through MDCG guidance documents, implementing regulations and evolving regulatory expectations.

An effective Authorised Representative should actively monitor these developments and understand how they affect represented manufacturers.

Transparency

Manufacturers should clearly understand:

which services are included,
which services attract additional fees,
how complaints are managed,
how documentation is controlled,
and how communication with Competent Authorities is handled.

Clear expectations at the beginning of the relationship often prevent misunderstandings later.

Practical Compliance Checklist for Manufacturers

Appointing an EU Authorised Representative is only the beginning. Maintaining a productive relationship requires regular communication and a clear understanding of each party’s responsibilities.

The following checklist can help manufacturers remain compliant throughout the product lifecycle.

Before Appointing an EU Authorised Representative

Before signing a mandate, consider the following:

Confirm that the Authorised Representative is legally established within the European Union.
Assess their experience with your type of medical device.
Verify that they have a qualified Person Responsible for Regulatory Compliance (PRRC).
Understand how they manage regulatory documentation, complaints and communication with Competent Authorities.
Review the scope of services included in the agreement.

Taking time to evaluate the representative at the beginning often prevents regulatory issues later.

After Appointment

Once the mandate has been signed, the manufacturer should ensure that the Authorised Representative has access to the information needed to fulfil its responsibilities.

This typically includes:

EU Declaration of Conformity.
Current Technical Documentation.
CE Certificate, where applicable.
Contact details for regulatory and quality personnel.
Complaint handling procedures.
Vigilance procedures.
Current versions of labelling and Instructions for Use.

It is equally important to establish clear communication channels. Both organisations should know who to contact when regulatory questions arise or when changes affect the device.

Keep the Authorised Representative Updated

One of the most common problems observed during regulatory inspections is that the Authorised Representative is working with outdated information.

Whenever significant changes occur, the manufacturer should notify the representative without delay.

Examples include:

Design changes.
Software updates.
Manufacturing site changes.
Quality Management System updates.
New CE certificates.
Changes to the intended purpose.
Field Safety Corrective Actions.
Serious incidents.
Regulatory inspections.
Changes affecting Technical Documentation.

Keeping the Authorised Representative informed helps ensure that regulatory records remain current and that responses to Competent Authorities are accurate.

Common Mistakes Manufacturers Should Avoid

Although the regulatory requirements are well defined, manufacturers occasionally encounter compliance issues because of avoidable mistakes.

Treating the Authorised Representative as a Label Requirement

Some organisations appoint an Authorised Representative simply because the MDR requires a European address on the product label.

This approach overlooks the broader regulatory responsibilities assigned to the representative.

The Authorised Representative should be viewed as a regulatory partner rather than just another service provider.

Providing Incomplete Documentation

The representative cannot effectively support regulatory activities if essential documents are unavailable or outdated.

Manufacturers should ensure that current versions of regulatory documents are always available whenever requested.

Poor Communication

Communication problems are one of the most frequent causes of regulatory delays.

If a manufacturer updates its Technical Documentation, changes its manufacturing process, receives a serious complaint or initiates a corrective action, the Authorised Representative should be informed promptly.

Unexpected questions from Competent Authorities become much easier to manage when both parties work with the same information.

Selecting an Authorised Representative Based Only on Cost

The least expensive option is not always the most suitable.

Manufacturers should consider experience, responsiveness, technical expertise and regulatory knowledge in addition to commercial factors.

A knowledgeable representative often adds value by identifying potential compliance issues before they become regulatory findings.

Not Reviewing the Written Mandate

The written mandate is more than a contractual formality.

It should clearly describe:

Responsibilities of both parties.
Communication processes.
Documentation requirements.
Complaint handling.
Confidentiality.
Termination arrangements.

A well-written mandate reduces misunderstandings and supports a smoother working relationship.

Frequently Asked Questions

Can one EU Authorised Representative represent multiple manufacturers?

Yes. Many Authorised Representatives support multiple manufacturers. Each relationship is established through a separate written mandate.

Can a manufacturer appoint multiple Authorised Representatives?

A manufacturer may appoint different Authorised Representatives for different generic device groups. However, a single generic device group cannot have more than one Authorised Representative at the same time.

Is the EU Authorised Representative responsible for CE certification?

No. Obtaining CE marking remains the manufacturer’s responsibility. The Authorised Representative verifies that the necessary conformity assessment has been completed where applicable but does not certify the device.

Does the Authorised Representative prepare Technical Documentation?

No. The manufacturer prepares and maintains the Technical Documentation. The Authorised Representative verifies that the required documentation exists and makes it available to Competent Authorities when requested.

Can an Authorised Representative refuse to represent a manufacturer?

Yes. Many Authorised Representatives perform regulatory due diligence before accepting a new manufacturer. If significant compliance gaps are identified, they may request corrective actions before agreeing to act on the manufacturer’s behalf.

What happens if the manufacturer changes its Authorised Representative?

The change should be managed in accordance with Article 12 of the MDR. The transition should be documented through a written agreement, responsibilities should be clearly transferred, and product labelling should be updated as appropriate.

Key Takeaways

The role of the EU Authorised Representative has evolved considerably under the MDR.

Some of the most important points to remember are:

Manufacturers established outside the European Union must appoint an EU Authorised Representative before placing medical devices on the EU market.
The relationship between the manufacturer and the Authorised Representative must be documented through a written mandate.
The Authorised Representative verifies the availability of key regulatory documentation, supports communication with Competent Authorities and assists during market surveillance activities.
The manufacturer continues to be fully responsible for compliance with Article 10 of the MDR.
The MDR introduced greater accountability for Authorised Representatives, including potential legal liability in certain circumstances.
Any change of Authorised Representative should follow the structured process described in Article 12.
Every Authorised Representative must have permanent and continuous access to a qualified Person Responsible for Regulatory Compliance.
Regular communication between the manufacturer and the Authorised Representative is essential for maintaining compliance throughout the product lifecycle.

Conclusion

The EU MDR has transformed the role of the EU Authorised Representative from a largely administrative function into an important element of the European regulatory framework for medical devices.

Today, the Authorised Representative supports regulatory compliance by maintaining access to essential documentation, acting as the manufacturer’s point of contact within the European Union, cooperating with Competent Authorities and assisting during market surveillance activities. These responsibilities contribute to greater transparency and strengthen regulatory oversight throughout the lifecycle of a medical device.

At the same time, the MDR makes it clear that responsibility for the safety, performance and regulatory compliance of the device continues to rest with the manufacturer. Appointing an EU Authorised Representative does not transfer these obligations; instead, it establishes a partnership that helps ensure effective communication and regulatory coordination within the European Union.

Manufacturers should therefore view the selection of an EU Authorised Representative as a strategic regulatory decision rather than simply another compliance requirement. Choosing a representative with relevant experience, strong regulatory knowledge and effective communication practices can make a significant difference throughout the life of a product, from initial market access to post-market surveillance.

As regulatory expectations continue to evolve, maintaining a collaborative relationship with an experienced EU Authorised Representative will remain an important part of achieving and sustaining compliance under the EU MDR.

References

Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices (EU MDR), Articles 11, 12 and 15.
Medical Device Coordination Group (MDCG). MDCG 2022-16 – Guidance on Authorised Representatives under Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
European Commission. Medical Devices – Guidance Documents (MDCG Publications).

About MedOrdyn Solutions

MedOrdyn Solutions supports medical device and in vitro diagnostic manufacturers with regulatory consulting services across the product lifecycle. Our expertise includes EU MDR and IVDR compliance, US FDA submissions, ISO 13485 Quality Management Systems, Clinical Evaluation, Risk Management, IEC 62304 software lifecycle compliance, Post-Market Surveillance, and global regulatory strategy.

We work with manufacturers to simplify regulatory requirements, support timely market access, and maintain compliance with applicable regulations.

For regulatory consulting and support, contact us at info@medordyn.com.