Module 16 2022

02/09/2022

Obligations under the Directives

Issue

AIMD

MDD

IVDD

Recall?

Withdrawal for any technical or medical reason

Systematic recall for any technical or medical reason connected with the characteristics or performance of a device

Of what?

A device

Devices of the same type

When to Report?

Any

Any that has or might lead to the death or a serious deterioration in the health of a patient or user

Any that has or might lead, directly or indirectly, to the death or a serious deterioration in the health of a patient or user or other persons.

The Organisation for Professionals in Regulatory Affairs

7

Obligations under the Guidance

Incident: ● “Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health.” Field Safety Corrective Action: ● “an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market.” ● Far broader than a recall

The Organisation for Professionals in Regulatory Affairs

8

4