How is a ‘product’ defined concerning GSPR and the pricing of services offered by an Authorised Representative?

In the context of the General Safety and Performance Requirements (GSPR), a ‘product’ refers to any medical device or related service intended for medical use, as outlined by relevant medical regulations and standards. The term encompasses a wide range of items, from software and instruments to apparatus and machines designed for diagnosis, prevention, monitoring, treatment, or alleviation of disease. Pertaining to the pricing of services by an Authorised Representative, the definition of a ‘product’ serves as a fundamental factor as it dictates the scope and complexity of the requirements to be met for compliance and market entry. The Authorised Representative’s functions may include ensuring adherence to GSPR guidelines, liaising with regulatory bodies, and maintaining documentation—a product’s classification can influence these responsibilities and the associated costs. Therefore, understanding the precise definition of a ‘product’ is crucial as it impacts both the responsibilities assigned to the Authorised Representative and the corresponding pricing model based on the level of involvement and expertise required.

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