In Annex I of the EU IVDR, the GSPRs are listed. The bulk of the standards, like GSPR 1, are founded on principles, guaranteeing that when the state of the art evolves, a manufacturer evaluates whether the IVD stays compliant.
The GSPRs are divided into three groups:
Chapter 1: GSPRs 1 to 8 in Annex I are general requirements. All IVDs are subject to these GSPRs.
Chapter 2: GSPRs 10 to 19 are performance, design, and manufacturing requirements, and each GSPR must be evaluated for its application.
Chapter 3: Requirements for Information Provided The last chapter of this Annex, With the Device, is devoted to one overarching criterion that applies to labels and instructions for usage. There are several sub-requirements inside this single GSPR. The majority of IVD will apply.