What is it? Why is it important?

A Serious Adverse Event (SAE) is an AE that led to any of the following:

  • Death
  • Serious deterioration in the health of the subject that resulted in any of the following:
    • Life-threatening illness or injury
    • Permanent impairment of a body structure or a body function
    • Hospitalisation or prolongation of patient hospitalisation
    • Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function
    • Chronic disease
  • Foetal distress, foetal death or a congenital physical or mental impairment or birth defect

A Serious Adverse Device Effect (SADE) is an SAE that is related, with a causal or reasonably possible relationship, to the use of:

  • The MD under investigation (IMD)
  • The MD comparator (e.g. a licensed MD used as a reference in the study), or
  • Investigational study procedures (e.g. MD set-up)

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Planned hospitalization for a pre-existing condition, or study procedure required by the protocol, without a serious deterioration in health, are not considered SAEs.

What do I need to do?

As a Site-INV:

  • Perform a causality assessment and determine whether the SAE is a SADE (definitively, probably, possibly related)
  • Report all SAEs to the SP-INV (e.g. normally within 24 hours, or based on specifications in the study protocol but not later than 3 days)

As a SP-INV:

  • Re-assess SAEs regarding seriousness, causality, and expectedness
  • An un-anticipated SADE (USADE) is a SADE, which by its nature, incidence, severity or outcome has not yet been identified (e.g. based on current risk assessment, such as the risk analysis report and/or CIP, the “instruction for use” for licensed MDs, the IB for non-licenced MDs (IMD))

During study conduct, all SAEs / SADEs must be fully investigated and documented in the:

  • Source Document (SDs) (e.g. participant original medical records during and after study conduct)
  • Study database / CDMS (eCRF)

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Documentation starts once the participant has signed the ICF until:

  • Study termination (e.g. last study participant at last study visit), or
  • The end of some predefined safety follow-up period (e.g. as defined in the study protocol)

As a SP-INV of a category A study, report SAEs with a causal relationship to study procedures:

  • To EC within 7 (e.g. via BASEC)

As a SP-INV of a category A study report SADEs to:

  • The supplier of the IMD or MD comparator
  • EC within 7 days (e.g. via BASEC)
  • Swissmedic via the Materiovigilance unit of your hospital. SADEs occurring in category A study are serious incidents, and are immediately reported to Swissmedic but no later than:
    • 2 days, in the event of a serious public health threat
    • 10 days, in the event of death or unanticipated serious deterioration in a person’s state of health
    • 15 days, if a causal relationship was established.

As a SP-INV of a category C study, report SADEs (e.g. include events that occurred abroad for conformity-related studies with risk category C1 / C2) within 7 days to:

  • EC (e.g. via BASEC)
  • Swissmedic, via the portal for medical device (e.g. via electronic eDoc submission)

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

Swissethics – see in particular

  • Templates and checklists / Notification
    • SAE medical devices

Swissmedic – see in particular

  • Information sheet
    • MU680_20_004e_MB Medical devices FAQs Patients
  • Medical Devices
    • Clinical trials
    • Submissions during ongoing clinical trials
    • How to submit?

References

ISO 14155:2020 Medical device (access liable to cost) – see in particular sections

  • 3.44 SADE
  • 3.45 SAE
  • 3.51 USADE
  • 3.52 Use error

MDCG 2020-10/1– see in particular guideline

  • 3.3 SAE definition

MDR 2017-745 – see in particular articles

  • Art. 2 (58) SAE definition
  • Art. 80 (1) Recording and reporting of AE that occur during clinical investigations

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.306 ClinO-MD
  • 812.213 MedDO

ClinO-MD – see in particular article

  • Art. 33 Reporting of Serious Adverse Events

MedDO – see in particular article

  • Art. 66 Reporting Obligations
Abbreviations
  • AE – Adverse Event
  • BASEC - Business Administration System for Ethics Committees
  • CDMS – Clinical Data Management System
  • CIP – Clinical Investigation Plan
  • ClinO-MD - Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • eCRF – electronic Case Report Form
  • FAQ – Frequently Asked Questions
  • FEDLEX – Publication Platform for Federal Laws
  • IMD – Investigational Medicinal Device
  • ICF – Informed Consent Form
  • ISO - International Organization for Standardization
  • MedDO – Medical Device Ordinance
  • MDCG – Medical Device Coordination Group
  • MDR – Medical Device Regulation (EU)
  • SADE – Serious Adverse Device Effect
  • SAE – Serious Adverse Event
  • SD – Source Documents
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
  • USADE – Unanticipated Serious Adverse Device Effect
Conduct ↦ Safety ↦ Medical Device Safety Reporting ↦ Serious Adverse Event and Device Effect
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Conduct ↦ Safety ↦ Medical Device Safety Reporting ↦ Serious Adverse Event and Device Effect

Please note: the Easy-GCS tool is currently under construction.