What is it? Why is it important?

A Device Deficiency (DD) is a Medical Device (MD) inadequacy with regard to its identity, quality, durability, reliability, safety or performance (e.g. malfunction, misuse or use error, inadequate labelling, instructions).

A DD with SAE potential is an events that might have led to a SAE if:

  • Suitable action had not been taken
  • Intervention(s) had not been implemented
  • Circumstances had been less fortunate

What do I need to do?

As a Site-INV:

  • Record and report all DDs to the SP-INV (e.g. use the timeframe as the defined in the study protocol, but no later than 3 days upon awareness)

As a SP-INV:

  • Assess the DD and its potential to have led to a SAE
  • Report all DD with SAE potential (e.g. based on risk category)

For risk category C studies, report all DD with SAE potential (including events that occurred abroad for conformity-related studies with risk category C1 / C2) within 7 days to:

  • EC via BASEC (e.g. using a safety form)
  • Swissmedic via eDoc, the portal for medical device
  • The supplier of the IMD

For risk category A studies, report all DD with SAE potential to:

  • The supplier of the IMD (via Materiovigilance)
  • EC within 7 days via BASEC (e.g. using a safety form)
  • Swissmedic via the Materiovigilance system of your hospital. DDs with SAE potential fall within the definition of serious incident. Serious incidents are immediately reported but no later than:
    • 2 days, if there is 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, for all other serious incidents

More

For risk category A and C studies, DDs 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)

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)

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

  • 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

  • 3.19 DD definition
  • 7.4 AE and DD
  • 9.2.5 Safety evaluation and reporting (SP-INV)
  • 10.8 Safety reporting (site-INV)

MDCG 2020-10/1 – see in particular guidelines

  • 3.4 DD definition
  • 5 Reportable events

MDR 2017-745 – see in particular articles

  • Art. 2 (59) DD definition
  • Art. 80 Recording and reporting of AEs
  • Art.87-89 Reporting of serious incidents

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.306 ClinO-MD
  • 812.213 MedDO

ClinO-MD – see in particular articles

  • Art. 33 Reporting of Serious Adverse Events
  • Art. 34 Reporting of safety and protective measures

MedDO – see in particular article

  • Art. 66 Reporting Obligations
Abbreviations
  • AE – Adverse Event
  • BASEC - Business Administration System for Ethics Committees
  • CTU – Clinical Trials Unit
  • DD – Device Deficiency
  • ClinO-MD - Ordinance on Clinical Trials with Medical Device
  • CDMS – Clinical Data Management System
  • DD – Device Deficiency
  • EC – Ethics Committee
  • eCRF – electronic Case Report Form
  • FEDLEX – Publication Platform for Federal Laws
  • ICF – Informed Consent Form
  • IMD – Investigational Medicinal Device
  • ISO - International Organization for Standardization
  • MedDO - Medical Device Ordinance
  • MDCG - Medical Device Coordination Group (EU)
  • MDR – Medical Device Regulation (EU)
  • SAE – Serious Adverse Event
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Conduct ↦ Safety ↦ Medical Device Safety Reporting ↦ Device Deficiency
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 ↦ Device Deficiency

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