News
DEADLINE MDR Application Notified Body Transition periods
Regulation (EU) 2023/607 has extended the transitional periods for placing medical devices on the market under certain conditions. However, the extension of the TRANSITIONAL PERIODS is EXCLUDED if the conformity assessment has not been APPLIED for at a REGULATED BODY by 26.05.2024.
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BMG is planning to allow off-label use (use outside the intended purpose) for medical devices
The Federal Ministry of Health (BMG) is planning to amend the Medical Devices Operator Ordinance (MPBetreibV) to allow off-label use (use outside the intended purpose) for medical devices.
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