Informational Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD)

[Marcelo]

Manufacturers with CE Marking shall update their procedures and forms.

Fabricantes com Marcação CE devem atualizar seus procedimentos e formulários.

Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD)

New Manufacturer Incident Report helptext.

Continue reading...

 

[Abelmini]

Manufacturers with CE Marking shall update their procedures and forms.

Fabricantes com Marcação CE devem atualizar seus procedimentos e formulários.

Hi all,

I am new to "the cave" and want to thank everybody for the things I already learned as a "ghost reader". Now it is time to share my knowledge and ask my own question, that is why I signed in.

Regarding the new incident form: Is it already mandatory? Are there any transitional periods? Did anyone discover changes in the coding (compared to the FDA codes)?

Thank you all

 

[Abelmini]

Hi all (cove not cave),

any news regarding this topic? I am still confused when to start using this new medical incident form sheet.

Thank you all

 

[Ronen E]

Hi all (cove not cave),

any news regarding this topic? I am still confused when to start using this new medical incident form sheet.

Thank you all

The MDR's date of application is 26.5.2020.

 

[Jean_B]

If you visit the listing for the MedDev guidances at https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en you'll find that while it's available from January 2019, it seems to become mandatory as of January 2020.

"
New MIR form - as from January 2019
New manufacturer incident report (from 1 January 2019)
New manufacturer incident report helptext
New manufacturer incident report (for implementation in manufacturers databases before January 2020)
"

 

[Abelmini]

Thanks for the replies.
This is showing exactly my dilemma. Yes, I know that date of application is May next year. Yes, I know that it seems to become mandatory January 2020. But which date is the correct one?