GSPR — General safety and performance requirements

The set of requirements every device must meet before it can be CE marked, covering general safety, design and manufacture, and the information supplied with the device. Compliance is demonstrated requirement by requirement, and the evidence sits in the technical documentation. Requirements that do not apply to a given device must be justified rather than ignored.

Reference: MDR Annex I; IVDR Annex I

TD — Technical documentation

The manufacturer’s evidence file showing that a device meets the applicable requirements. Its contents are prescribed rather than optional: device description, design and manufacturing information, evidence against the general safety and performance requirements, risk management, verification and validation, and post-market surveillance documentation.

Reference: MDR Article 10(4) and Annexes II and III; IVDR Article 10(4) and Annexes II and III