General Safety and Performance Requirements (GSPR) are a set of requirements that medical device manufacturers must comply with in order to ensure the safety and performance of their products. These requirements are set out in the European Medical Device Regulation (MDR) and cover areas such as design, manufacturing, labeling, clinical evaluation, post-market surveillance, and risk management.
The GSPRs are intended to ensure that medical devices placed on the market in the European Union (EU) are safe and effective for their intended use, and that they provide the necessary level of protection for patients, users, and other stakeholders. Compliance with the GSPRs is mandatory for all medical devices sold in the EU, and manufacturers are required to provide evidence of compliance as part of the conformity assessment process.
