Incident Report for Medical Devices

According to article 11 of Act no. 16/2001 on medical devices manufacturers, suppliers and users are obliged to report to IMA any malfunction or deterioration in the characteristics and/or performance of a device which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health.

New MIR form applicable from January 2020

New incident form for manufacturers, which will take effect on January 1st 2020

New manufacturer incident report (pdf file, only works in Internet Explorer)
New manufacturer incident report helptext (excel file)
New manufacturer incident report (for implentation in manufacturers databases before January 2020)

Var efnið hjálplegt Yes No

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