EU Authorised Representatives

Introduction

Working with EU Authorised Representatives for Medical Devices and IVDs

For medical device manufacturers based outside the European Union, it is crucial to appoint an EU Authorised Representative to access these markets.

LFH Regulatory specialises in connecting you with trusted EU Authorised Representatives to ensure your products follow all necessary regulations and successfully enter the European markets.

Our Coordination Services with EU Authorised Representatives

01. Ensuring Compliance

We partner with professional EU Authorised Representatives to guarantee that your medical devices follow relevant European regulations and standards, including the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).

02. Regulatory Documentation Review

Our network of EU Authorised Representatives, LFH Regulatory acts as a bridge between your company and the regulatory authorities in Europe. We help all necessary communications, providing seamless interactions without requiring your physical presence.

03. Handling Incidents and Reporting

In case of product safety incidents or recalls, LFH Regulatory coordinates with your EU Authorised Representative to manage all communication and reporting obligations to the authorities efficiently and effectively.

04. Labelling and Documentation

We work closely with EU Authorised Representatives to ensure that your product labelling and documentation meet all regulatory standards. LFH Regulatory helps support all documentation in a state of readiness for regulatory inspections.

Are You Ready to Access the EU Markets?

We collaborate with EU Authorised Representatives. If you are a non-EU manufacturer looking to market your devices in Europe, working through an EU Authorised Representative is mandatory.

LFH Regulatory helps you prove and keep this essential relationship, ensuring compliance and helping communication with relevant EU authorities.

Explore Our Supporting Services

LFH Regulatory offers an array of services to meet the diverse needs of our clients. Our comprehensive suite of services includes:

Regulatory

The evolving regulatory landscape, including the Medical Device Regulation 2017/745, makes bringing medical devices to market challenging.

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Quality

Ensuring quality is essential in the medical device industry. Patient safety, regulatory compliance, and market success all hinge on the quality and consistency of your medical products.

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We recognise the critical importance of your QMS to your organisation, customers, patients, and regulatory agencies.

Whether you are navigating the complex UK and European markets or expanding your reach globally, our QMS expertise is tailored to meet your specific needs.

Clinical

Clinical and performance evaluations are a vital step in validating the safety and efficacy of your medical devices or IVDs.

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Global Registrations

LFH Regulatory provides global registration services to help medical device and In Vitro Diagnostics manufacturers navigate international compliance and market access.

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We can help with everything from feasibility assessment to effective lifecycle management, as well as integrating a robust quality management system into your business operations.

Authorised Representative

LFH Regulatory offers UK Responsible Person and EU Authorised Representative services to ensure compliance with UK MDR 2002 and EU regulations for medical devices.

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Training

Understanding Medical Device and In Vitro Diagnostic (IVD) regulations is complex and requires a comprehensive understanding of the entire product lifecycle.

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We can help with everything from feasibility assessment to effective lifecycle management, as well as integrating a robust quality management system into your business operations.

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EU Authorised Representatives

Introduction

Working with EU Authorised Representatives for Medical Devices and IVDs

"With our support, you can focus on growth while we handle EU compliance."

Our Coordination Services with EU Authorised Representatives

Are You Ready to Access the EU Markets?

Explore Our Supporting Services

Regulatory

Technical File

Risk Management

Biological Evaluation

Regulatory Strategy / Market Access

Regulatory Intelligence (RI) Services

Quality

QMS implementation including ISO 13485 & MDSAP

Clinical

Clinical Evaluation

Performance Evaluation

Global Registrations

Global registration services

Authorised Representative

UK Responsible Person Services