Working with EU Authorised Representatives for Medical Devices

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. 

Are you ready to access the EU Markets?

Our Coordination Services with EU Authorised Representatives

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).

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.

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.

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?

Europe

Collaborating 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.

Additional Services

As a full-service Medical Device Compliance Company, we offer a suite of additional services:

Expertise and Experience

Our consultants possess extensive knowledge of UK regulatory requirements and are well-versed in the intricacies of the medical device industry. With our expertise, we guide you through the compliance process, reducing risk and ensuring successful market access.

Regulatory Strategy Development

We collaborate closely with you to develop a tailored regulatory strategy that aligns with your business goals. Our experts assess your device portfolio, identify regulatory requirements, and assist in implementing strategies for successful market access.