The Medical Device Coordination Group (MDCG) has released a new draft guidance document (MDCG 2025-X) clarifying the requirements for trend reporting under the EU Regulations on Medical Devices (MDR) and In Vitro Diagnostic Devices (IVDR).
Trend reporting is a cornerstone of post-market surveillance (PMS) and requires manufacturers to monitor and report any statistically significant increase in non-serious incidents, expected undesirable side effects, or expected erroneous results. These findings can impact the benefit-risk analysis and ultimately patient safety.
Why this matters for manufacturers:
- Integration with PMS and QMS – Manufacturers must define methodologies, thresholds, and observation periods in their PMS plans.
- Applicability to legacy devices – Guidance clarifies reporting obligations across different regulatory statuses.
- Risk management alignment – ISO 14971:2019 principles should be used to evaluate increases in frequency or severity.
- Geographical scope – Events worldwide must be considered, communicating detected trends to respective competent authorities and submitted to EUDAMED once fully functional.
📖 Read the draft guidance here.