The Essential Requirements of Directive 93/42/EEC become the General Safety and Performance Requirements (GSPR)

💡 The Essential Requirements of Directive 93/42/EEC become the General Safety and Performance Requirements (GSPR) under Regulation (EU) 2017/745. The requirements in the new regulatory text are expanded and more explicit but remain consistent with the Directive. EGSPs include some new features such as devices without medical purpose and requirements for devices used by non-specialists.

💡 Examples of topics covered by the PSMG are devices incorporating materials of biological origin and documentation accompanying medical devices. The MDR (EU) requires manufacturers to demonstrate compliance with the PSMGs. Requirements that are not applicable will also have to be justified. Harmonised standards and common specifications are options for manufacturers to use for demonstration.