What is the specific role of an Authorised Representative?
The specific role of an Authorised Representative varies depending on the context, directives and the regulations involved.
Task of an Authorised Representative
The tasks that can be delegated to the Authorised Representative according to the directives and regulations are of an administrative nature. Depending on the conformity assessment procedure and the specific directive/regulation, the Authorised Representative, for instance, may be tasked with ensuring and declaring the product’s compliance with the essential requirements, affixing the CE marking on the product, and, when necessary, indicating the number of the Notified Body, preparing and signing the EC/EU Declaration of Conformity, or making the declaration and technical documentation available to national supervisory authorities.
The manufacturer explicitly designates, in writing, the Authorised Representative, who can, on behalf of the manufacturer, be contacted by the authorities of the Member States concerning the manufacturer’s responsibilities under the New Approach directives/regulations.
The name and address of the Authorised Representative must also be placed near the CE marking on the product or on the product’s packaging. This allows regulatory authorities, end-users/professionals, and other stakeholders to easily identify and contact the Authorised Representative if necessary. The contact details typically include the name and address of the Authorised Representative, and they serve as a point of contact for inquiries or information related to the product’s compliance, safety, and regulatory matters.
AR Expert as your Authorised Representative
The specific tasks of an Authorised Representative may vary depending on the legislation and the type of product involved. Therefore, please contact us, as we act as EU Authorised Representative and UK Authorised Representative and as EC Rep and UK Responsible Person (UKRP) for medical devices.
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