european authorized representative manner any natural or legal character set up in the Union who has obtained and commonplace a written mandate from a producer, located outdoor the eu Union, to behave on the producer’s behalf regarding distinct obligations given in MDR 2017/745.
If the manufacturer is positioned outside the european Union or the manufacturer does not have a registered place of job inside the ecu Union, if so, the producer might also rent a consultant from the european Union known as an authorized eu representative.
the european authorised representative additionally referred to as as CEREP,EUAR, eu REP,EC REP and EAR.
manufacturer and accepted consultant should sign a Mandate/ agreement earlier than starting up any pastime. The mandate have to in reality outline the roles and obligations of the each events and the designation shall represent the approved representative’s mandate, it will likely be valid best whilst installed in writing thru the accepted consultant and will be powerful at least for all devices of the same ordinary device group.
The eu permitted consultant shall carry out the responsibilities particular within the mandate agreed between it and the manufacturer. The authorized consultant shall provide a replica of the mandate to the in a position authorities of member country upon request. we’ve got already discussed approximately ecu MDR in our previous articles, you could refer the ones for more info.
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Medical devices consultancy 