Module 16 2022

02/09/2022

Legal Reporting Obligation

Precise wording and location differs – often an “undertaking” or declaration ● Body of Devices Directive for Class I devices ● Conformity assessment procedures for other devices ● Declaration of conformity for IVDs Obligation to report to competent authorities ● Incidents that “might lead or might have led to” – Death of a patient or user (or other person), or – Serious deterioration in health ● Incidents leading to systematic recall

The Organisation for Professionals in Regulatory Affairs

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Obligations under the Directives

Issue

AIMD

MDD

IVDD

What to report?

Deterioration in the characteristics or performances, and any inaccuracies in the instruction leaflet for a device

Malfunction or deterioration of a device and inadequacy in the labelling or instructions for use

Malfunction, failure or deterioration of a device and inadequacy in the labelling or instructions for use

When?

might lead or might have led to the death or a deterioration in the health of a patient

might lead or might have led to the death or a serious deterioration in the health of a patient or user

might lead or might have led, directly or indirectly, to the death or a serious deterioration in the health of a patient or user or other persons

Corrective Action?

No

Yes

Yes, taking account of the nature and risks in relation to the product

The Organisation for Professionals in Regulatory Affairs

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