Transition period for manufacturers to adopt new versions of medical device standards - IMDRF

[Gledy Martinez]

La industria y los reguladores son conscientes del período de transición hacia nuevas versiones de normas o cambios en una monografía. Estos suelen establecer un período de transición. ¿El IMDRF (Foro Internacional de Reguladores de Dispositivos Médicos), organización que reúne a varios países de alta vigilancia, habrá definido en algún documento o publicación sobre los períodos de transición para que los fabricantes adopten nuevas versiones de estándares de dispositivos médicos?:aceptar:

DeepL translation added:

Industry and regulators are aware of the transition period to new versions of standards or changes in a monograph. Does the IMDRF (International Medical Device Regulators Forum), an organisation that brings together several countries with high vigilance, have defined in any document or publication transition periods for manufacturers to adopt new versions of medical device standards?

 

[planB]

FDA specifically, provides transition periods for recognised consensus standard, as elaborated here.

To my knowledge IMDRF is not not involved in the development of standards and does not propose or define related transition periods. Some standard organisations may define transition periods in a case-by-case basis for some or all of their documents.