Authorized representatives under the MDR

| November 21, 2018

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The EU Medical Devices Regulation 2017/745 (MDR) has significantly increased the burden of compliance and potential legal liability exposure for economic operators, including EU authorized representatives (ARs) of manufacturers established outside of the European Economic Area (EEA), Switzerland and Turkey. Whereas the main focus of the EU Medical Devices Directive 93/42/EEC (MDD) was the manufacturer of a medical device, the MDR explicitly identifies a pivotal role for ARs in ensuring the compliance of the medical devices produced by manufacturers established outside the EU as well as serving as their contact persons within the EU.

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