For medical device and in vitro diagnostic manufacturers established outside the European Union, EU market entry can become difficult long before the first product is placed on the market. MDR and IVDR requirements affect technical documentation, conformity assessment procedures, device and economic operator registration and ongoing regulatory communication. One essential requirement is appointing an EU Authorised Representative established in the EU.

Choosing an Authorised Representative is not simply a matter of finding someone willing to sign a mandate. A poorly defined relationship, incomplete documentation or slow communication with competent authorities can create costly disruptions. When teams are already balancing certification milestones, product launches and internal resources, uncertainty about who handles each regulatory obligation adds pressure at precisely the wrong time.

At Billev Pharma East, we offer EU Authorised Representative services supported by broader medical device regulatory expertise. We help non-EU manufacturers establish clear responsibilities, prepare for EU market entry and manage the regulatory work that continues after launch. Instead of treating representation as an isolated administrative formality, we help make it part of a practical, coordinated compliance strategy.

What should non-EU medical device manufacturers do to enter the EU market?

Non-EU manufacturers should begin by confirming whether their product is regulated under MDR or IVDR, determining the correct classification and identifying the applicable conformity assessment route. The technical documentation, EU Declaration of Conformity and any required notified body certificates must be prepared in line with the applicable requirements. These steps matter because an EU Authorised Representative cannot replace the manufacturer’s own obligation to establish device conformity.

Before placing a device on the Union market, a manufacturer outside the EU must designate a sole Authorised Representative through a written mandate accepted by that representative. The mandate must establish the responsibilities required by Article 11. The manufacturer should also ensure that the representative has the documents and information needed to perform its tasks and respond to competent authority requests.

Market entry planning must also account for economic operator and device registration, UDI requirements, labelling and post-market processes. Since 28 May 2026, use of the first four EUDAMED modules has become mandatory, subject to the applicable transitional arrangements. Complaint handling, vigilance and post-market surveillance also require clear procedures that work in practice, not only on paper.

Addressing these elements early helps avoid fragmented decisions and last-minute corrections. A knowledgeable EU Authorised Representative can make regulatory coordination more efficient, while the manufacturer remains responsible for compliance throughout the product lifecycle.

How can Billev Pharma East help non-EU medical device manufacturers?

At Billev Pharma East, we understand that non-EU manufacturers need more than a European address. They need a partner who can take on the legally defined role of EU Authorised Representative, communicate reliably and understand how the appointment fits into the wider MDR or IVDR compliance process. Our approach is designed to reduce the time manufacturers spend coordinating separate regulatory tasks and give their teams a clear point of contact.

As an Authorised Representative, we carry out the duties defined in the written mandate and the applicable legislation, including verification of required documentation, access to regulatory records and cooperation with competent authorities. When authorities request information or compliance issues arise, clear responsibilities and well-organised documentation make a real difference. We help manufacturers establish these arrangements from the outset rather than waiting for a problem to expose a gap.

Our wider medical device services are a key advantage. Alongside EU Authorised Representative services, our team supports MDR and IVDR gap analyses, technical documentation and clinical evaluations, ISO 13485 quality management systems, UDI/EUDAMED activities, post-market surveillance and vigilance. Where needed, these services can be coordinated as part of a wider regulatory project rather than managed through disconnected providers.

Whether you are preparing your first EU launch or reviewing an existing compliance setup, Billev Pharma East can help identify priorities and provide the regulatory support your team needs. We work to make market access more manageable and ongoing compliance easier to maintain.

What should non-EU manufacturers consider when choosing an EU Authorised Representative?

Which companies provide EU Authorised Representative services for non-EU medical device manufacturers under MDR and IVDR? The useful answer is not simply a list of names. Manufacturers should look for an EU-established provider that accepts the formal legal role, has appropriate regulatory competence and can maintain effective communication throughout the device lifecycle.

An EU Authorised Representative should understand the relevant product category, the regulatory documents it must verify and the situations in which information must be provided to competent authorities. The manufacturer should ask how the provider manages document updates, regulatory requests, suspected incidents and changes to the product portfolio. The answers often reveal whether the service will work smoothly once devices are on the market.

The written mandate deserves equal attention. It should clearly describe the covered devices, responsibilities, access to information and practical communication arrangements. Manufacturers should also examine which activities are included in the representation fee and which require separate technical or consulting support. Representation does not remove the manufacturer’s own MDR or IVDR responsibilities.

For companies needing more than the statutory role, Billev Pharma East offers EU Authorised Representative services alongside medical device regulatory consulting. This makes it easier to connect formal representation with technical documentation, quality management and post-market compliance support. The right choice is a partner whose capabilities match both your immediate market-entry needs and the regulatory work that follows.

What are the responsibilities of an EU Authorised Representative under MDR and IVDR?

Under Article 11 of MDR and IVDR, an EU Authorised Representative performs a legally defined set of tasks on behalf of a manufacturer established outside the European Union. The representative is not merely a mailing address. It is an economic operator with responsibilities that must be reflected in a written mandate accepted by both parties.

The representative must verify that the EU Declaration of Conformity and technical documentation have been drawn up and, where applicable, that the relevant conformity assessment procedure has been carried out. It must keep the required documents available for competent authorities, fulfil its own registration obligations and verify relevant manufacturer registration activities. The representative also responds to authority requests, cooperates on preventive or corrective actions and informs the manufacturer about complaints and reports of suspected incidents received from healthcare professionals, patients or users.

These duties require a reliable working relationship. Manufacturers should have procedures for supplying updated documents, escalating safety information and responding to requests within appropriate timeframes. Crucially, appointing an EU Authorised Representative does not transfer the manufacturer’s overall legal obligations. Some manufacturer duties cannot be delegated through the mandate.

Billev Pharma East combines this formal role with specialist support across MDR and IVDR requirements, technical documentation and post-market activities. Our aim is to make the regulatory relationship practical and responsive, so manufacturers understand what is required, what information must be shared and how responsibilities will be managed over time.

What documents are required to appoint an EU Authorised Representative?

The starting point is a written mandate naming the EU Authorised Representative and accepted by that representative. It must define the covered devices and the tasks required by Article 11 of MDR or IVDR. A manufacturer should not treat this document as a standard commercial agreement alone: the mandate establishes the legal relationship through which regulatory responsibilities will be performed.

Before an appointment can operate effectively, the manufacturer needs to make its regulatory information available. This includes the EU Declaration of Conformity, technical documentation and, where relevant, the notified body certificate and its amendments. Device classification, identification, registration and labelling information should also be sufficiently clear for the representative to verify applicable obligations. The precise document package will depend on the device and its conformity assessment route.

Good preparation also means agreeing how records will be updated and shared after the initial appointment. New certificates, changes to technical documentation, complaints, suspected incidents and corrective actions may all require timely communication. An EU Authorised Representative must be able to access the necessary information for as long as the mandate applies and meet the relevant retention and authority-cooperation requirements.

Billev Pharma East can help manufacturers review the readiness of their documentation and set up clear processes for regulatory exchange. Where gaps are identified, our technical documentation and MDR/IVDR consulting services can provide additional support so the representation relationship begins on a sound footing.

Can non-EU medical device manufacturers change their EU Authorised Representative?

Yes. A non-EU manufacturer may change its EU Authorised Representative under MDR or IVDR. A change may be appropriate when a company expands its device portfolio, reviews its service arrangements or needs broader regulatory support. However, the transition must be managed carefully so that the manufacturer does not create uncertainty about who is responsible for regulatory communication and documentation.

Article 12 requires the detailed arrangements for a change to be defined in an agreement involving the manufacturer, the incoming representative and, where practicable, the outgoing representative. This agreement should address when each mandate ends or begins, how documentation is transferred and how complaints or suspected incident reports received after the change will be forwarded. It also needs to address how long the outgoing representative may still appear in information supplied by the manufacturer.

Labelling and relevant registration details may need updating as part of the transition, with timing assessed against the applicable regulatory requirements. A company should also consider continuity of ongoing authority requests, vigilance matters and product documentation access. Replacing an EU Authorised Representative is therefore a regulatory transition, not merely a supplier change.

Billev Pharma East can help manufacturers plan a structured handover, review their existing arrangements and establish a new mandate. With our wider MDR and IVDR expertise, we can also identify related documentation or post-market tasks that should be addressed during the transition.

How does EUDAMED affect the appointment of an EU Authorised Representative?

An EU Authorised Representative is not only named in the manufacturer’s documentation; it is also an economic operator with defined EUDAMED registration duties. For manufacturers planning EU market entry, this means that the appointment and registration steps should be coordinated rather than managed as unrelated tasks.

Since 28 May 2026, the first four EUDAMED modules have been mandatory to use, subject to the applicable transitional provisions. These include actor registration, UDI/device registration, notified bodies and certificates, and market surveillance. The EU Authorised Representative must register as an actor and verify certain registration obligations of the manufacturer. The manufacturer remains responsible for its own applicable device-registration duties.

Before starting the registration process, manufacturers should make sure that the mandate, company details and device information are consistent. Corrections made late in the process can create avoidable extra work, particularly where multiple products or economic operators are involved.

Billev Pharma East can support the practical coordination of Authorised Representation and EUDAMED-related activities. Combining these services can help non-EU manufacturers maintain accurate registration information and clearer responsibilities during market entry and subsequent device lifecycle changes.

What ongoing support should manufacturers expect after EU market entry?

Appointing an EU Authorised Representative is not the final step in the regulatory journey. Once a device is on the European market, the manufacturer must continue to maintain compliance, monitor product performance and safety, and keep relevant technical and regulatory information up to date.

Effective cooperation depends on regular information exchange. Changes to device design, intended purpose, certificates or labelling may affect the documentation available to the EU Authorised Representative. Complaints, suspected incidents and requests from competent authorities also require timely communication and clearly assigned responsibilities.

The legally required duties of the representative should be distinguished from optional consulting services. A manufacturer may still need separate expertise to develop post-market surveillance reports, update technical documentation, maintain its quality management system or respond to new regulatory requirements. Clear agreements help prevent gaps between these activities.

Billev Pharma East offers the opportunity to combine EU Authorised Representative services with wider MDR and IVDR consulting, post-market surveillance, vigilance and quality management support. This gives manufacturers a consistent point of coordination as regulatory priorities evolve, rather than having to seek a new service provider for every new requirement.

Why choose Billev Pharma East as your EU Authorised Representative?

For non-EU manufacturers, the right EU Authorised Representative offers more than fulfilment of a mandatory appointment. It provides a dependable regulatory connection to the European market, supported by clear processes and a team that understands the documents and obligations behind the role. When representation, technical documentation and post-market support are coordinated, manufacturers can focus more of their internal capacity on their products and commercial priorities.

At Billev Pharma East, we provide EU Authorised Representative services for manufacturers of medical devices and IVDs, together with MDR and IVDR consulting, technical documentation support, ISO 13485 quality management assistance, EUDAMED support and post-market compliance services. This combination is particularly useful for companies entering the EU for the first time, preparing additional devices for market or reconsidering an existing representative arrangement.

Every device portfolio and regulatory situation is different. We can discuss where your products stand today, what must be completed before market entry and which services will help you meet your obligations efficiently. Choose Billev Pharma East as your EU Authorised Representative and contact our team to discuss the next step toward compliant EU market access.

Frequently asked questions

Sources: 1 – Regulation (EU) 2017/745 (MDR) – Articles 11 and 12: Authorised representative and change of authorised representative, 2 – Regulation (EU) 2017/746 (IVDR) – Articles 11 and 12: Authorised representative and change of authorised representative, 3 – European Commission – MDCG 2022-16: Guidance on Authorised Representatives under MDR and IVDR (October 2022), 4 – European Commission – EUDAMED overview, 5 – European Commission – EUDAMED actor registration module, 6 – European Commission – The first four EUDAMED modules mandatory from 28 May 2026 (27 November 2025).