Amendment: IVDR 2017/746 transitional provisions & in-house devices
This procedure updates the rules for in vitro diagnostic medical devices (IVDs), which are tests used to detect diseases or monitor health. It focuses on extending transition periods to ensure that essential diagnostic tools remain available on the market while manufacturers adapt to stricter EU safety and performance standards.
This affects medical device manufacturers and healthcare providers. It prevents sudden shortages of diagnostic tests by delaying the deadline for certain devices and in-house tests to meet new regulatory requirements.
Documents
Amendment to Regulation (EU) 2017/746
position · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
proposal · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
proposal · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
proposal · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
proposal · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
proposal · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
proposal · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
proposal · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
proposal · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
proposal · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
proposal · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
proposal · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
proposal · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
proposal · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
proposal · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
report · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
proposal · EN · 2026-05-08
Amendment to Regulation (EU) 2017/746
proposal · EN · 2026-05-08