GSPRs Matrix

For the device part of each combination product, or category or group of combination products, technical documentation must be constructed for demonstrating conformity to the General Safety and Performance Requirements (GSPRs) of Medical Devices (Medical Device Regulation – Annex I).

In a GSPRs matrix the following information is collected:

• The 23 requirements as stated in Annex I of the MDR
• Applicable (A) or Not Applicable (N/A) per requirement
• If a requirement is N/A, provide justification
• In case of A, the method of demonstrating compliance, e.g. reference to standard, common specification, FDA or EU guidance document, in-house test method
• In case of A, identifier of dedicated document showing conformity to the specific requirement
• In case of A, location where the document can be found within the design and development file

See the Technical documentation review strategies for maintaining the GSPRs matrix.