Glossary · EU medical devices: MDR
General safety and performance requirements (GSPR)
Also known as: GSPR, Annex I requirements (MDR and IVDR)
Under the EU Medical Device Regulation (EU) 2017/745 and IVD Regulation (EU) 2017/746, the general safety and performance requirements (GSPR) in Annex I are the requirements every device must meet, taking into account its intended purpose. Annex I has three chapters: general requirements, requirements regarding design and manufacture, and requirements regarding the information supplied with the device.
- EU
- MDR
- IVDR
- Technical documentation
In one sentence
The GSPR in Annex I of MDR and IVDR are the safety and performance requirements every device must meet, from risk management to labeling and IFU.
Example
A manufacturer of a surgical laser keeps a GSPR checklist that lists each applicable Annex I requirement, the harmonized standards and common specifications applied, and the test report or document in the technical file that shows conformity.
How it applies
- Chapter I, general requirements: Devices must achieve their intended performance and be safe, with risks acceptable against the benefits and reduced as far as possible, taking the generally acknowledged state of the art into account. The manufacturer runs a risk management system across the lifecycle; ISO 14971 is the usual means.
- Chapter II, design and manufacture: Covers topics such as chemical and biological properties, infection and contamination, devices with a measuring function, protection against radiation, electronic programmable systems and software, and protection against mechanical and electrical risks.
- Chapter III, information supplied: Sets the content of the label and the instructions for use (Section 23 MDR, Section 20 IVDR); see labeling and IFU.
- Standards: Applying harmonized standards cited in the Official Journal gives a presumption of conformity with the requirements they cover; common specifications can also be used where adopted.
- Technical documentation: Annex II requires a GSPR checklist in the technical documentation: for each requirement, whether it applies (with a justification if not), the method used to show conformity, the standards applied and the reference to the controlled evidence.
GSPR vs. essential requirements
The essential requirements of the former directives were the predecessor of the GSPR. The GSPR are more detailed, for example on software, IT security, lay users and information supplied. A checklist written against the directive’s essential requirements has to be rebuilt against MDR or IVDR Annex I.