Question 1

What is an EU Authorized Representative (EU-REP), and do I need one?

Accepted Answer

An EU Authorized Representative is a legally appointed person or entity within the European Union acting on behalf of a manufacturer located outside the EU. They ensure compliance with EU medical device (MDR, Article 11) or in vitro diagnostic (IVDR, Article 11) regulations, handle communication with EU authorities, keep available technical documentation, and assist in vigilance reporting. If you’re a non-EU manufacturer intending to place medical devices or IVDs on the EU market, you must appoint an EU-REP.

Question 2

What are the duties and responsibilities of a UK Responsible Person (UKRP)?

Accepted Answer

A UK Responsible Person is appointed by a manufacturer outside the UK who wishes to place medical devices or IVDs in Great Britain. Their responsibilities include acting as the liaison with the UK regulator (MHRA), ensuring that technical documentation is available, maintaining compliance with UK regulatory requirements, receiving safety-oriented notices, and supporting vigilance and post-market surveillance.

Question 3

How does the Swiss Authorized Representative (CH-REP) differ from EU or UK representation?

Accepted Answer

The Swiss Authorized Representative is required for non-Swiss manufacturers who want to distribute medical devices or IVDs in Switzerland. While many regulatory principles are aligned with EU rules, there are Swiss-specific laws, market authorization, labeling, vigilance, and documentation obligations. The CH-REP ensures those local requirements are met and serves as the contact point for Swiss authorities.

Question 4

What documentation is required for representation under MDR/IVDR or equivalent regulations?

Accepted Answer

Required documentation typically includes the complete technical file (including device description, design/manufacturing information, general safety & performance requirements, risk management, clinical evaluation or performance evidence), labeling and instructions for use, quality management system certificates (if applicable), post-market surveillance procedures, labelling showing the Authorized Representative’s name/address, etc.

Question 5

Who interacts with the regulatory authorities, and what happens if there’s a query or inspection?

Accepted Answer

The Authorized Representative acts as the official point of contact for authorities in the EU, UK, or Switzerland. They manage inquiries, submissions, and vigilance / safety reporting. In case of inspections by competent authorities, the Representative supports this process, ensuring that documentation is available and any corrective actions required are communicated and implemented.

Question 6

What happens if my product labeling or instructions for use do not include the Authorized Representative’s information?

Accepted Answer

Without correctly referencing the Authorized Representative (name, address etc.), regulatory authorities may consider the device non-compliant, which can lead to delays in market access, recalls, or enforcement actions. It is essential that labeling and documentation follow the specific regulatory requirements for each market (EU / UK / Switzerland) and include the Representative’s details.

Question 7

What are the ongoing obligations after the product is on the market?

Accepted Answer

Once a product is on the market, you must continually ensure compliance. Ongoing obligations include: monitoring for safety and adverse events (vigilance), maintaining updated technical documentation, ensuring labeling remains accurate, reporting changes in regulations and updating products accordingly, handling post-market surveillance, and being prepared for authority inspections.

Representation Services for Medical Devices and IVDs

Coverage by Region

EU Authorized Representative (EU-REP / EC-REP)

UK Responsible Person (UKRP)

Swiss Authorized Representative (CH-REP)

How We Work - From Onboarding to Ongoing Compliance

Discovery & Eligibility

Representation Agreement

Documentation Readiness

Authority Interface

Monitoring & Updates

Why MedNet EC‑REP

Secure, Privacy‑First Operations

Transparent Communication

Scalable Support

Compliance you can trust

Our Certifications & Compliance

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Frequently asked Questions