Module 16 2024

17/10/2024

Trending

Article 88 - Manufacturers shall report, by means of the electronic system referred to in Article 92, any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects that could have a significant impact on the benefit-risk analysis ► C2 referred to in Sections 1 and 8 of Annex I and which ◄ have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits

Refers to incidents that are not serious i.e., not reportable per Article 87, Vigilance.

The manufacturer must monitor all incidents and identify changes in the risk-evaluation.

The manufacturer must report the changes via EUDAMED.

The PSUR is a mechanism for reporting (see MDCG 2022-21).

Changes in severity may result in a serious incident and should be reported as such.

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• Types of Trending

UCL

AV.

Sample Mean

LCL

Frequency

Time

Time

Simple flagging system: •

Simple time-based trending: • The frequency of events is recorded each month to

Control Charts: •

More than one incident of the same type in defined period triggers trend monitoring A change in severity can trigger trend monitoring

Control charts set Upper and Lower control limits If the frequency of occurrence goes above the control limit action is required

determine if there is an upward trend

•

•

•

Control limits can be dynamic

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