Technical documentation section:
4. GSPR and applied standards
This section of the technical documentation demonstrates conformity with the General Safety and Performance Requirements (GSPR) set out in Annex I of Regulation (EU) 2017/745 (MDR). It includes documentation that shows how each applicable requirement is fulfilled and which harmonized or other relevant standards have been applied to meet these requirements.
List of applied standards
A list of harmonized standards, common specifications, and other relevant standards or guidelines that have been applied to the design, manufacture, and performance of the medical device. The list should include:
- Standard number and title
- Edition or year of issue
- Applicability to the device
- Evidence of compliance (e.g., test reports, certificates, declarations)
GSPR matrix
A comprehensive matrix that maps each applicable GSPR to the corresponding evidence provided in the technical documentation. The matrix includes:
- Each applicable GSPR clause from Annex I of the MDR
- Whether the requirement is applicable to the device
- A justification if a requirement is not applicable
- A reference to the documentation demonstrating conformity (e.g., test reports, risk management documents, clinical evaluation)
Below, you will find links to information about the documents included in Section 4 of MDR-compliant technical documentation, covering key requirements for GSPR and applied standards documentation.
