Learn about our EU Authorised Representative Service for Medical Devices
An EU Authorised Representative (AR) plays a crucial role in the regulation of medical devices. The EU Authorised Representative is a natural or legal person appointed by a medical device manufacturer, not established in the EU, to act on their behalf in relation to specified tasks with regard to compliance with Medical Devices Regulation (MDR) or the In Vitro Diagnostic Devices Regulation (IVDR).
We specialise in assisting medical device manufacturers outside the European Union (EU) in meeting their regulatory obligations by acting as their dedicated Authorised Representative. Our comprehensive services ensure compliance with the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR). Partner with us to navigate the complex regulatory landscape and successfully bring your medical devices to the European market.
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The Authorised Representative serves as a contact point for EU Competent Authorities. They assist in communication and coordination between the manufacturer and the relevant regulatory authorities.
The AR ensures that the manufacturer complies with the requirements of the MDR or IVDR. This involves verifying that the necessary conformity assessments have been conducted, technical documentation is in place, and other regulatory obligations are met.
The AR is responsible for keeping the required documentation, such as the EU Declaration of Conformity and technical documentation, available for inspection by Competent Authorities.
The AR collaborates with importers and distributors to make sure that the devices placed on the market comply with regulatory requirements.
The AR participates in post-market surveillance activities and informs the manufacturer about serious incidents and field safety corrective actions.
Our experts have extensive experience with the regulations and stay up-to-date with the latest EU regulations, ensuring that your products comply with all legal requirements.
As your dedicated Authorised Representative, we serve as the primary point of contact with EU Competent Authorities. Our streamlined communication processes facilitate quick and efficient interactions, helping you navigate regulatory hurdles seamlessly.
We understand the intricacies of EU MDR and IVDR compliance. Our services cover a wide range of tasks, including verifying conformity assessments, maintaining essential documentation, and ensuring ongoing compliance with evolving regulations.
Each manufacturer is unique, and so are their products. We offer customised solutions tailored to your specific needs. Whether you are a small startup or a well-established company, our services are designed to fit your business model and ensure compliance at every stage.
Before you embark on the journey of entering the EU market, our experts provide thorough regulatory consultations. We guide you through the applicable regulations, helping you understand the steps required for compliance and ensuring a smooth market entry process.
Our team assists in conducting comprehensive conformity assessments, ensuring that your medical devices meet the stringent requirements set by the EU authorities. We work closely with manufacturers to identify and address any potential compliance gaps.
Maintaining accurate and up-to-date documentation is a critical aspect of EU MDR and IVDR compliance. We take the burden of managing essential documents such as the EU Declaration of Conformity and technical documentation, ensuring readiness for regulatory inspections.
Our services extend beyond market entry. We actively participate in post-market surveillance activities, keeping a vigilant eye on the performance of your medical devices in the EU market. In case of any incidents, we promptly inform you and assist in implementing necessary corrective actions.
Building strong partnerships with importers and distributors is essential for successful market penetration. We collaborate with these stakeholders on your behalf, ensuring that your products are distributed and handled in compliance with EU regulations.
The regulatory landscape is dynamic, with changes occurring regularly. We keep you informed about any amendments or updates to EU regulations, enabling you to adapt swiftly and maintain continuous compliance.
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