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EUROPEAN Authorized REPRESENTATION
A European Authorized Representative (EAR) service is Requirement for Non-European manufacturers. It involves appointing a representative within the European Union to ensure compliance with MDR 2017/745 regulations and facilitate communication with European authorities.
An European Authorized Representative (EAR) service is a requirement for Non-European manufacturers to appoint a representative in the European Union to ensure compliance with regulations and facilitate communication with European authorities.
Why do you need an EUROPEAN Authorized Representative?
If you are a Medical Device or an Invitro Diagnostic device manufacturer, without a registered office in the European Union, you must appoint a local European Authorized Representative to meet the requirements of the Regulation (EU) 2017/745 for Medical Devices or Regulation (EU) 2017/746 Invitro Diagnostic Devices as guided by the European Medical Regulation.
- Amstermed B.V. can guide you through the compliance process and register your Class I medical devices. We can help you research new markets and maintain control of your device registrations.
- With offices around the world, we have the capacity and the expertise to design a regulatory strategy to help you reach your target markets.
A Free Sale Certificate is provided by the relevant Competent Authority provides evidence that the medical device is legally sold and demonstrates that it meets all the regulatory requirements for sale in European Union.
Amstermed established within the Union can apply for Free Sale with the Competent Authority of The Netherlands when it has accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks.
Appoint Amstermed as Authorized Representative
Appoint Amstermed as your (manufacturer) Authorized Representative To Enter European Market
Throughout the process, Amstermed acts as the liaison between ( the manufacturer) and the regulatory authorities, ensuring smooth communication, and timely completion of the necessary steps to obtain the free sale certificate.
Application for Free Sale Certificate
Amstermed submits the application for the free sale certificate on behalf of the manufacturer to the relevant regulatory authority in the EU.
Application Review
The regulatory authority reviews the application, documentation, and evidence of compliance submitted by Amstermed.
Additional Information Requests
If requested by the regulatory authority Amstermed assists the manufacturer in providing any additional information or clarifications to address their queries.
Certificate Issuance
Upon successful review and approval, the regulatory authority or designated body issues the free sale certificate. This certificate confirms that the medical devices comply with the applicable EU regulations and can be freely traded on the European market.
- Amstermed has developed a structured process and supports successful transition of medical device and IVD manufacturers from different authorized representative. Amstermed has extensive experience supporting a smooth transition.
- Cooperate with the competent authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by the medical devices and
- Inform the manufacturer about complaints or reports from healthcare professionals, patients, and users about suspected incidents related to the device
