EU AUTHORIZED REPRESENTATIVE – Medical Devices EU Authorized Representative
MEQUIPE, has the competence required by European laws to legally represent in the European Community, manufacturers who wish to place their devices on the market but who reside outside The European territory.
To fully understand the role of the EU REPRESENTATIVE,the latest regulatory prescription concerning the world of medical devices,mequipe’s core business, the Regulation (EU) 2017/745 on MedicalDevices was taken as a reference:
“Any natural or legal person established in the Union, who has received and accepted from the manufacturer, established outside the Union, a written mandate authorising him to act on behalf of the manufacturer in relation to certain activities with regard to the requirements of the regulatory and regulatory framework to which he belongs to his products.”
In addition, in the event that the Manufacturer does not have the capacity to meet the obligations of the European regulatory and regulatory framework, MEQUIPE may:
- Adapt the Technical Dossier,
- Adapting the product to European standards, also intervening on design,
- Carry out all electrical safety tests,
- Manage Clinical Investigation Protocols to demonstrate the clinical effectiveness of the devices,
- Support the Manufacturer’s European Customers, in order to obtain the necessary information required, so that they can achieve the regulatory and regulatory objectives of the same,
- Support the Manufacturer by guaranteeing his presence at European Trade Fairs,
MEQUIPE offers its experience gained in over 30 years of activity in the field of product and system certification, especially in the medical field, to allow you to place your products on the market in the EUROPEAN COMMUNITY!
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