European Authorized Representative for Medical Device Companies

A European Authorized Representative for Medical Device Companies is essential for non-EU manufacturers who want to sell their products in Europe. Under the EU MDR (2017/745) and IVDR (2017/746), appointing an Authorized Representative is not optional but a legal requirement. This representative acts as the official link between manufacturers outside the EU and European regulatory authorities, ensuring CE Marking compliance, handling technical documentation, and providing post-market support. Without a European Authorized Representative, medical device companies cannot legally access the EU market.

What is a European Authorized Representative for Medical Device Companies?

A European Authorized Representative for Medical Device Companies is a legal entity based within the European Union (EU) that acts as a liaison between non-EU manufacturers and EU regulatory authorities. It ensures that medical devices comply with EU MDR (2017/745) or IVDR (2017/746) before being placed on the European market.

Why is a European Authorized Representative important for Medical Device Companies?

Appointing a European Authorized Representative for Medical Device Companies is crucial because:

• It is mandatory under EU law for non-EU manufacturers.
• They ensure CE Marking compliance.
• They act as a contact point for EU regulators and Notified Bodies.
• They manage technical documentation and incident reporting.
• They give manufacturers market access to all EU countries.

Who needs to appoint a European Authorized Representative for Medical Device Companies?

• Non-EU manufacturers of medical devices who want to sell in the EU market.
• Companies outside the EEA (European Economic Area), including the UK post-Brexit.
• Importers and distributors in the EU cannot replace the role of an Authorized Representative.

Roles and Responsibilities of a European Authorized Representative for Medical Device Companies

The responsibilities of a European Authorized Representative for Medical Device Companies include:

• Verifying that Declaration of Conformity and CE marking are in place.
• Ensuring technical documentation is available for EU authorities.
• Acting as a communication link between manufacturers and regulators.
• Handling incident reporting and corrective actions.
• Representing the manufacturer during inspections or audits.

What are the requirements to appoint a European Authorized Representative for Medical Device Companies?

• Must be legally established in the EU.
• Should have expertise in EU MDR/IVDR regulations.
• Must sign a written mandate agreement with the manufacturer.
• Should have the capacity to maintain technical files for up to 10–15 years.

How to choose the right European Authorized Representative for Medical Device Companies?

When selecting a European Authorized Representative for Medical Device Companies, consider:

• Experience with CE Marking and EU MDR/IVDR.
• Strong regulatory and legal knowledge.
• Good reputation and credibility in the EU market.
• Transparent pricing with no hidden costs.
• Ability to support during audits and inspections.

Documents Required by European Authorized Representative for Medical Device Companies

Here’s the list of documents required by a European Authorized Representative for Medical Device Companies:

• Declaration of Conformity (DoC)
• CE Marking Certificate (if applicable)
• Technical Documentation (Technical File / Design Dossier)
• Risk Management File
• Clinical Evaluation Report (CER) / Performance Evaluation Report (PER)
• Post-Market Surveillance (PMS) Plan
• Vigilance and Incident Reporting Procedures
• UDI (Unique Device Identification) Information
• Labeling and Packaging Information
• Quality Management System (QMS) Certificates
• Manufacturer’s Details
• Mandate/Contract Agreement
• Device Registration Information (EUDAMED)

Costs in appointing European Authorized Representative for Medical Device Companies

The cost of a European Authorized Representative for Medical Device Companies depends on:

• Type of device (Class I, IIa, IIb, III).
• Scope of services (basic representation or full compliance support).
• Annual fees range from €2,000 – €15,000, plus additional charges for audits or document review.

How does a European Authorized Representative help with CE Marking compliance for Medical Device Companies?

A European Authorized Representative for Medical Device Companies helps with CE Marking by:

• Reviewing documentation and technical files.
• Ensuring compliance with EU MDR 2017/745 or IVDR 2017/746.
• Coordinating with Notified Bodies.
• Maintaining post-market surveillance records.
• Acting as the EU contact on device labeling and packaging.

What are the risks of not appointing a European Authorized Representative for Medical Device Companies?

If a manufacturer does not appoint a European Authorized Representative for Medical Device Companies, risks include:

• Legal penalties and bans on product sales in the EU.
• Seizure of products at customs.
• Loss of CE Marking approval.
• Reputation damage with distributors, hospitals, and regulators.

How can ELT Corporate assist as a European Authorized Representative for Medical Device Companies?

ELT Corporate is a best regulatory consultancy that supports manufacturers by acting as a European Authorized Representative for Medical Device Companies. Services include:

• Acting as your official EU Authorized Representative.
• Reviewing and maintaining technical documentation.
• Supporting CE Marking and regulatory submissions.
• Handling vigilance and post-market reporting.
• Coordinating with Notified Bodies and EU authorities.
• Offering affordable and transparent service packages.