Authorized Representative under CE MDR - Your Gateway to the European Market
An authorized representative refers to an individual or organization that operates on behalf of a medical device manufacturer within the European Union.
Non-EU manufacturers that want to obtain CE certification or place their medical device/in vitro diagnostic devices (IVD) on the EU market must appoint an authorized representative located within the European Union.
The authorized representative bears specific obligations according to the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), including:
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Ensuring that the manufacturer has a valid declaration of conformity and technical documentation for each device.
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Registering the devices and the manufacturer in EUDAMED.
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Keeping a copy of the declaration of conformity and technical documentation available for inspection by competent authorities.
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Reporting incidents and field safety corrective actions to competent authorities.
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Cooperating with competent authorities on any preventive or corrective action.
The authorised representative must have the necessary qualifications and resources to perform their tasks and must not be involved in the design, manufacture, packaging, or labelling of the devices.
Our regulatory professionals already have a lot of experience acting as European Authorized Representatives and providing consulting services for more than 10 years.
So, we can successfully carry out the complex requirements of EU regulations.
Contact us today, and let's embark on this journey together.
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