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In the global regulatory environment for medical and in vitro diagnostic devices, manufacturers operating outside a given market are often required to appoint a local representative Marketing medical devices in the eu can be a challenge Two distinct roles exist in this context
The authorized representative and the legal representative. The definition states that an authorized representative refers to a natural or legal person established within the european union who has received and accepted a written mandate from a manufacturer located outside the union. This is important, because under the directives, only the manufacturer or authorized representative is identified as the responsible party for the conduct of a clinical investigation.
Let’s delve into the primary responsibilities of an authorized representative and understand their pivotal role in regulatory affairs within the medical device sector.
The amendment introduces a clearly defined term for the “authorized representative” in the context of medical device labeling This change aims to enhance clarity and ensure a consistent understanding across different regions and stakeholders. Bs en iso 13485:2016, the standard for a qms for medical device organizations, has a requirement to appoint a management representative It should be noted that the responsibilities of the management representative and the person responsible for regulatory compliance are not the same.
The regulations clarify the respective responsibilities of authorised representatives, importers and distributors, as well as the tasks that could be delegated by the legal manufacturer to the authorised representative.
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