Conduct↦Safety↦Medical Device Safety Reporting↦Device Deficiency
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, usability, safety or performance (e.g. malfunction, misuse or use error, inadequate labelling, instructions).
A DD with SAE potential is an event 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 defined in the Clinical Investigation Plan, 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) without delay (e.g. within 7 days according to MDCG) to:
- EC via BASEC portal (e.g. using a safety form)
- Swissmedic via via e-message ortal for medical device (e.g. please refer to Swissmedic website for further instructions)
- 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 without delay via BASEC portal, using a safety form (e.g. within 7 days according to MDCG)
- 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:
- The study is finished for the participant, 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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
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
- 3.5 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