Active medical devices & energy-emitting devices
MDR Annex VIII, Rules 9–13 and Rule 22 govern active device classification. MDR Annex I, GSPR §14–16 and §19–22 cover design requirements for active and energy-emitting devices.
MDR Annex VIII, Rules 9–13 and Rule 22 govern active device classification. MDR Annex I, GSPR §14–16 and §19–22 cover design requirements for active and energy-emitting devices.