Back in 2021, the European Commission proposed a regulation on general product safety (GPSR). The aim is to implement the regulation thus repealing the currently valid directives.
The GPSR provides for aspects like cybersecurity and post-market surveillance. It is planned to entry into force until mid-2023 and to become obligatory by the end of 2024.
Manufacturers of medical devices are not excluded from the scope of the regulation. Critical voices are concerned that overlaps with other (planned) regulations, like for example cybersecurity or artificial intelligence, cause confusion and overregulation.
Source: Johner Institute