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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.

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EU Authorised Representatives LFH Regulatory
EU Authorised Representatives LFH Regulatory
EU Authorised Representatives LFH Regulatory

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

Alexander Madell

EU Authorised Representatives LFH Regulatory
EU Authorised Representatives LFH Regulatory

Our Coordination Services with EU Authorised Representatives

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).
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.
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.
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.
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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.