Under Article 11 of the Medical Device Regulation, every manufacturer established outside the European Union must appoint an Authorised Representative before placing a device on the Union market.
Amstermed acts as that Authorised Representative from Amsterdam, holding the technical documentation, liaising with competent authorities, and maintaining registration in EUDAMED on the manufacturer’s behalf.
Our mandate covers Class I, Class IIa, Class IIb, Class III medical devices and the full IVDR classification set from Class A through Class D.
Manufacturers established outside the European Union placing medical devices on the EU market.
In-vitro diagnostic manufacturers with distribution in any Member State.
Legacy device holders transitioning from MDD or IVDD to the current Regulations.
OEM and private-label manufacturers whose products are distributed under a Union brand.
Confirming that the EU Declaration of Conformity and technical documentation have been drawn up and that the conformity assessment procedure has been carried out by the manufacturer.
Registering the manufacturer, Authorised Representative mandate, and devices in the European database (EUDAMED) with the associated Basic UDI-DI and UDI-DI identifiers.
Acting as the point of contact for competent authorities of Member States in respect of preventive and corrective actions and inspections.
Immediate notification of serious incidents, field safety corrective actions, trend reports, and post-market surveillance findings.
Keeping a copy of the technical documentation, EU Declaration of Conformity, certificates and amendments available to authorities for the retention period.
Managing termination of mandate with the competent authority and orderly transfer of the mandate to a successor Authorised Representative where required.
A permanent Union address recognised by the Dutch competent authority (IGJ) and listed publicly in EUDAMED.
Coordinated representation across EU, UK, Switzerland and Australia under a single mandate framework.
Written mandate in accordance with Article 11(3) MDR with defined tasks, retention periods, and liability provisions.
EU Declaration of Conformity signed by the manufacturer
Technical documentation per Annexes II and III of the applicable Regulation
Notified Body certificates, where applicable
ISO 13485 certificate, or equivalent quality management evidence
Post-market surveillance plan and periodic safety update report
Instructions for use and labelling in required Union languages
Free Sale Certificate and manufacturer establishment evidence
Ten years after the last device covered by the Declaration of Conformity has been placed on the market. For implantable devices, the period is fifteen years.
Amstermed applies the same standard process to every representation and consulting engagement, adapted to the requirements of the specific jurisdiction.
The process is designed to make regulatory obligations legible, auditable, and durable. Each stage produces documentation that becomes part of the permanent mandate record.
Written inquiry received via encrypted email or Threema. Scope and jurisdictions are outlined. A mutual non-disclosure agreement is executed.
Existing regulatory documentation is reviewed: Declaration of Conformity, certificates, quality management evidence, labelling, and technical file summary.
Amstermed regulatory reviewers assess device classification, applicable regulation, and any gaps against the requirements of the target jurisdiction.
A written mandate is drafted defining scope, term, retention obligations, termination and successor provisions, in accordance with the applicable regulation.
The mandate is executed by both parties. Amstermed formally accepts the appointment and coordinates the manufacturer's regulatory particulars.
Notification is made to the competent authority: EUDAMED, MHRA DORS, Swissmedic, TGA ARTG, or FDA registration and listing as applicable.
From inquiry to registration, a straightforward mandate is typically completed within four to eight weeks, subject to the completeness of manufacturer documentation and authority processing times.
Regulatory obligations for European Union Authorised Representative are set out in the primary framework above, complemented by guidance documents issued by the relevant competent authority and applicable delegated or implementing acts.
Manufacturers established outside the European Union placing medical devices on the EU market.
Legacy devices subject to conditional continued placement, subject to specified conditions.
All devices in scope must comply with the current framework.
Our regulatory expertise covers a broad spectrum of medical devices and in vitro diagnostic technologies. We support manufacturers across multiple product categories, providing tailored regulatory guidance, documentation, and compliance strategies that align with the specific requirements of each device type and target market.
Need an EU Authorised Representative for your medical device? Our regulatory specialists are ready to guide you through every stage of the appointment, documentation, and compliance process, ensuring a smooth path to the European market.