Compliance with the Medical Device Regulation (MDR) and In-Vitro Medical Regulation (IVDR) is crucial in the complex and highly regulated
As an Authorised Representative (AR) in the European Union (EU), the role encompasses critical responsibilities regarding the management of manufacturer
On May 26, 2021, the Medical Device Regulation (MDR) 2017/745 went into full effect. One of the key changes included
Manufacturers who are not based in the EU have to rely on an Authorised Representatives if they wish to introduce
Unique Device Identification is being implemented on a global scale at a fast pace to allow authorities and economic operators
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