The Medical Devices Coordination Group (MDCG) has issued new guidance clarifying important terms and concepts on vigilance stated in the Medical Devices Regulation (MDR) 2017/745. Among others, this guidance, following a Q&A format, addresses the following topics:
Difference between an ‘incident’ and a ‘serious incident’ with a device under the MDR
The main difference between an “incident” and a “serious incident” under the MDR is the severity of the related health or public health outcome (or potential outcome) linked to an issue with a device made available on the market. In particular, the document provides a flowchart on the reportability of an incident under MDR for further clarification.
Basic reporting criteria for a serious incident
Basic reporting criteria go from A to C and are based on the following:
- Criteria A: an incident has occurred;
- Criteria B: the incident directly or indirectly led, might have led or might lead to any of the outcomes of a serious incident;
- Criteria C: there is an established, reasonably possible or suspected causal relationship between the serious incident and the manufacturer’s device.
How to apply the reporting timelines defined by Article 87(3) to (5) MDR
The reporting timeline is an important aspect to consider when reporting serious incident. Typically, the reporting should start on the day of the incident’s awareness date. The incident timeframe established is two, 10, or 15 days, depending on the seriousness of the incident.
Where to find information on vigilance reporting in EUDAMED
Until Eudamed becomes fully functional, competent economic operators should follow MDCG Guidance 2021-1.
Finally, the guidance also describes relevant concepts, such as:
- The user of a device;
- Undesirable side effect
- Field safety corrective action
- Periodic Summary Report
All the information can find in our Library of documents: MDR – MDR section.
Leave a Reply