Technical documentation section 4. GSPR and applied standards:

4.2 GSPR matrix

The General safety and performance requirements or GSPR matrix is a key component of the MDR-compliant technical documentation. It provides a structured approach to demonstrate conformity with the requirements set out in Annex I of Regulation 2017/745 on medical devices (MDR). The matrix outlines each applicable requirement, its applicability to the device under evaluation, and references to the documents that provide evidence of conformity.

Structure of the GSPR matrix

The matrix is presented in tabular format and typically includes the following columns:

• GSPR number (corresponding to the numbering in Annex I)
• Requirement summary
• Applicability (applicable / not applicable)
• Justification for non-applicability (if marked as not applicable)
• Reference to supporting documentation

Assessment of applicability

Each requirement from Annex I is reviewed to determine whether it is relevant to the device. If a requirement is not applicable, a clear justification is provided. This may include references to the intended purpose, mode of action, or design characteristics of the device.

Reference to validating documents

Where a requirement is applicable, the matrix includes cross-references to the specific sections or documents within the technical documentation that demonstrate conformity. These may include:

• Risk management file
• Usability engineering documentation
• Clinical evaluation report
• Test reports
• Instructions for use (IFU)
• Labeling and packaging information
• Verification and validation reports

Purpose and regulatory value

The GSPR matrix facilitates systematic and transparent demonstration of compliance with the MDR. It enables internal reviewers, external auditors, and Notified Body representatives to verify how each relevant safety and performance requirement has been addressed, helping to streamline conformity assessment procedures.

Integration with other technical documentation elements

The GSPR matrix is interconnected with other elements of the technical documentation. It supports traceability across the Quality Management System by linking high-level regulatory requirements to concrete evidence of design, risk control, and performance verification.