Kanzlei Dr. Jäkel – Rechtsanwalt und Arzt, Fachanwalt für Medizinrecht - Kooperation mit Jorzig Rechtsanwälte Berlin . Düsseldorf

 

News

News

DEADLINE MDR Application Notified Body Transition periods

DEADLINE MDR Application Notified Body Transition periods
Thursday, 02 May 2024

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

BMG is planning to allow off-label use (use outside the intended purpose) for medical devices
Monday, 20 November 2023

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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