According to the Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Regulation 2017/746 (IVDR), an EU Authorised Representative (EU AR) needs to be designated by all medical device or in vitro diagnostic manufacturers based outside the EU that wish to sell their products in any of the Member States (MDR/IVDR Article 11).
EU representation is a requirement for all manufacturers established outside the EU, without any physical presence (i.e., address) in an EU country.
A Person Responsible for Regulatory Requirements (PRRC) is required by the Medical Device Regulation 2017/745 (MDR, Article 15.6) and In vitro Medical Device Regulations 2017/746 (IVDR, Article 15.6) for EU Authorised Representative (EUAR).
EUDAMED (European Database on Medical Devices) is the IT system established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro medical devices, created to improve transparency and coordination of information regarding medical devices available on the EU market.
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