General Safety and Performance Requirements (GSPRs)
The General Safety and Performance Requirements (GSPRs) are applicable to all IVDs (deemed as “device” according to IVDR) and are listed in Annex I of the IVDR. They are divided into 3 categories:
- general requirements
- requirements regarding performance, design and manufacturing, and
- requirements regarding information supplied with the device.
Numerous detailed items are specified in these three categories and must be fulfilled. For instance, the manufacturer must demonstrate that the device achieves the intended analytical and clinical performance and is fit for its intended purpose under normal conditions of use. The manufacturer must maintain a risk management and must evaluate the safety of the IVD device. For each device, information must be provided on labels, on packaging and in the instructions for use.
