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Welcome to Advena Ltd - Malta

EU Authorised Representative, Regulatory & Quality Consultants for Medical Devices

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The European database on medical devices (Eudamed) is a live directory of economic operators, medical devices, and other related information,  which intends to provide access to the general public & healthcare professionals

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IVDR Date of Application

Article 110 for the Transitional Provisions of the In Vitro Diagnostic medical devices Regulation (EU) 2017/746 (IVDR) has been amended, providing certain manufacturers with additional time to meet the requirements of this Regulation.

IVDR Implementation

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