Amendment: Transitional provisions for medical & IVD devices
This procedure updates rules for medical devices and in vitro diagnostic devices. It aims to ensure continued availability of these devices while manufacturers adapt to new regulations, preventing shortages and protecting patient safety.
The changes affect manufacturers, healthcare providers, and patients. It provides extended deadlines for devices that meet older standards, allowing more time for full compliance with new EU regulations.
Documents
Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
position · EN · 2026-05-02
Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
proposal · EN · 2026-05-02
Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
proposal · EN · 2026-05-02
Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
proposal · EN · 2026-05-02
Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
proposal · EN · 2026-05-02
Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
proposal · EN · 2026-05-02
Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
proposal · EN · 2026-05-02
Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
proposal · EN · 2026-05-02
Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
proposal · EN · 2026-05-02