Authorised representative for non-EU manufacturer

What is binding for auhthorised repesentative (AR)?

Under the MDR (EU) 2017/745, Article 11 defines the legal "bridge" between a non-EU manufacturer and the European market. It shifts the role from a simple contact point to a highly accountable legal partner.

Here is the summary of Article 11 broken down by its core pillars:

The Mandatory Tasks (Article 11.3)

The manufacturer must provide a written mandate that officially requires the AR to:

Verify Compliance: Confirm that the Technical Documentation and EU Declaration of Conformity have been drawn up correctly.

Document Retention: Keep copies of all compliance documents available for authorities for 10 years (15 for implantables).

EUDAMED & Registration: Register the manufacturer and their devices in the EUDAMED database and verify all data is accurate.

Authority Liaison: Provide information and product samples to Competent Authorities upon request in the required official language.

Vigilance & Safety: Immediately inform the manufacturer of incidents/complaints and collaborate on Field Safety Corrective Actions (FSCAs).

Mentions in Technical Documentation (Annex II)

The AR must be identified in several specific parts of the manufacturer's technical files to ensure traceability:

The EU Declaration of Conformity (DoC): The name and registered address of the AR must be clearly stated alongside the manufacturer’s details.

Product Labeling: The official EC | REP symbol must be used on the device label, individual packaging, or sales packaging, followed by the AR’s name and address.

Instructions for Use (IFU): The AR’s contact details must be included so that the end-user or patient knows who the European legal representative is.

Clinical Evaluation & PMS Reports: The AR is often referenced in the Post-Market Surveillance (PMS) plan as the entity responsible for receiving and forwarding incident reports.

Defining Boundaries – "Non-Go" vs. Professional Support Tasks

An AR is a legal partner, not a technical service center. Clear boundaries prevent compliance risks for both parties.

"Non-Go" Zone (Forbidden Tasks):

Technical Repairs: ARs are legal entities, not repair shops or service centers.

QMS Ownership: They verify your ISO 13485 but cannot "own" or build it for you.

Primary Risk Assessment: Defining the "Intended Purpose" is a manufacturer-only task.

High-Value "Nice-to-Have" Support:

Adverse Event Liaison: While the manufacturer reports, the AR acts as the first EU contact, performing critical pre-analysis of incidents.

Communication Hub: Using their language and time-zone advantage, they efficiently manage end-user complaints and distributor inquiries.

Notified Body Advocate: If regulatory expertise is sufficient, the AR acts as a sophisticated bridge during audits and FSCA coordination.

Whar are the similar economic operators?

The MDR defines clear roles for every party in the supply chain to ensure total traceability and safety.

Importer: The EU-based entity that first places a device from a non-EU country on the Union market.

Labeling & EUDAMED: Along with the AR, the importer's name and address must appear on the product, its packaging, or an accompanying document. They must also register in EUDAMED to obtain an SRN.

Distributor: Any person in the supply chain, other than the manufacturer or importer, who makes a device available on the market.

Focus: Their primary role is verifying that the device bears the CE mark, the DoC has been drawn up, and that the importer/AR information is correctly labeled.

What can we support?

Professional EU Authorised Representative: We act as your legal "bridge," fulfilling all Article 11 mandates, including EUDAMED registration and mandate verification.

Technical Advocacy: We offer specialized support for MDR/IVDR certification, including the pre-examination of technical documentation and direct liaison with Notified Bodies.

Dual-Role Solutions (Importer & Distributor): For select high-potential devices, we serve as the Importer and Distributor, consolidating your EU supply chain and labeling requirements under one roof.

Outsourced AR Services: Many importers prefer to outsource the legal risks of representation. We act as your specialized, independent AR, managing all high-stakes regulatory tasks so you can focus on commercial growth.

Why Choose a Professional Partner?