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image of a blue circle with EU written in the middle and yellow stars all around the circle. This image represents the European Union (EU). The imaged is used by Patient Guard limited to highlight their EU Authorised Representative (EUAR) services and also to highlight areas on their website that cover EU regulatory requirements or news.

EU Authorised Representative

Blog, EU Regulations, Guides and Advice, Patient Guard News /

The EU Authorised Representative role for medical devices has existing since before the introduction of the Medical Device and In Vitro Diagnostic Regulations (EU MDR 2017/745 and EU IVDR 2017/746) were introduced in 2017 and was a requirement of their predecessors the medical device directives.

Since the MDR and IVDR Regulations were introduced the role of the EU Authorised Representative has become wider in scope and responsibilities.

EU Authorised Representative Read More »

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