An “Authorized Representative” and a “Responsible Person” are terms used in different contexts and have distinct meanings, primarily in the context of regulatory compliance within the European Union (EU). These terms apply to various industries, such as medical devices, cosmetics, and some other products, where compliance with EU regulations is essential. Here’s an explanation of the differences between these roles:
1. Authorized Representative:
An Authorized Representative (AR) is a regulatory concept often associated with medical devices, as outlined in the EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). The primary purpose of an Authorized Representative is to act on behalf of a manufacturer located outside the EU. Their role includes:
- Serving as the point of contact with EU authorities for regulatory matters.
- Ensuring that the manufacturer’s products comply with EU regulations.
- Coordinating the submission of regulatory documentation and information.
- Maintaining the manufacturer’s technical documentation and the EU Declaration of Conformity.
- Representing the manufacturer in dealings with competent authorities or notified bodies within the EU.
The Authorized Representative does not need to be involved in the day-to-day operations of the manufacturer but plays a crucial role in ensuring that the manufacturer’s products meet EU requirements.
2. Responsible Person:
A Responsible Person (RP) is a role specified in the EU Cosmetic Regulation (EC) No 1223/2009, applicable to cosmetics. The primary role of the Responsible Person is to ensure that cosmetic products placed on the EU market are safe for consumers. Their responsibilities include:
- Ensuring that the cosmetic products comply with safety requirements and are appropriately labeled.
- Maintaining the product information file, which includes details about the product’s safety assessment.
- Coordinating and responding to requests from EU authorities or consumers regarding product safety.
- Ensuring that the manufacturer is aware of their legal obligations under the EU Cosmetic Regulation.
- Handling product notifications and submitting information to the Cosmetic Products Notification Portal (CPNP).
The Responsible Person is often a legal entity or an individual located within the EU and has a more active role in overseeing the safety and compliance of cosmetic products.
In summary, the key distinction between an Authorized Representative and a Responsible Person is in the industries where these roles are employed and the specific regulatory requirements they are responsible for. An Authorized Representative is typically associated with medical devices and in-vitro diagnostics, while a Responsible Person is associated with cosmetics. Both roles, however, serve as intermediaries between non-EU manufacturers and EU regulatory authorities to ensure that products are compliant with EU regulations.