From May 26, 2022, the new Regulation on in vitro medical devices applies!
- IVDR fully applies from May 26, 2022
- CE Certificates issued under the Directive before May 26, 2022 may remain valid for up May 27, 2025
- IVDR introduces a new system of risk-based classification (Class A, B, C,D)
- While 70% of IVDs entering the EU Market under the IVDD were considered “self-declared”, under the IVDR 70% of IVDs will need to mandate the intervention of a Notified Body accredited under the IVDR in order to obtain the CE Mark and enter the EU market.
- The IVDR transitional period for “legacy” devices (above up-classified devices that will newly need a Notified Body and devices with a valid IVDD Certificate) is the following:
- 26 May 2025 for placing on the market of class D devices & devices with a valid IVDD Certificate [can be made available or put into service until 26 May 2026]
- 26 May 2026 for placing on the market of class C devices [can be made available or put into service until 26 May 2027]
- 26 May 2027 for placing on the market of class B devices [can be made available or put into service until 26 May 2028]
- 26 May 2027 for placing on the market of class A devices placed on the market in sterile condition [can be made available or put into service until 26 May 2028]
- Non-legacy devices entering the market from 26 May 2022 must fully comply with the IVDR
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