Thus, these medical device directives valid until that date will cease to apply:
With the entry into force of the IVDR, the dates for transition periods have been partially adjusted:
25 May 2022-26 May 2025
Certificates still issued under the IVDD can remain valid until 26 May 2025; however, all Class D devices placed on the market after 26 May 2025 must be fully compliant with the IVDR.
By 26 May 2026
All Class C devices placed on the market after 26 May 2026 must be fully compliant with the IVDR.
26 May 2027
All class B devices and class A sterile devices placed on the market after 26 May 2027 must be fully compliant with the IVDR.
Continued without change from 26 May 2022
All non-sterile class A devices placed on the market after 25 May 2022 must be fully compliant with the IVDR. All new devices placed on the market must comply with the IVDR.
Source:
EC: In Vitro Diagnostic Medical Devices Regulation (IVDR)
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