News about GMP/cGMP

27.05.2022

EC: IVDR for In-vitro-Diagnostic Medical Devices Entered into Force

EC: IVDR for In-vitro-Diagnostic Medical Devices Entered into Force

After a one-year postponement period, the European In Vitro Diagnostic Medical Devices Regulation (IVDR) finally came into force on 26 May 2022 and follows the Medical Device Regulation (MDR), which has been in force for one year.


Thus, these medical device directives valid until that date will cease to apply:

  • Directive on Active Implantable Medical Devices 90/385/EEC (AIMD)
  • Directive on Medical Devices 93/42/EEC (MDD)
  • Directive on in vitro diagnostic medical devices 98/79/EC (IVDD).


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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