The MDCG PMS and Vigilance Working Group released the draft Trend Report Form and guidance documents: HERE

These documents, along with the meeting minutes, were uploaded last week.

NOTE: All linked documents are drafts. They have not been officially published on the Commission’s website. The final versions may differ, but we are sharing the drafts now to give readers an early view of what is under development.

Manufacturer Trend Report (MTR) Form

The draft MTR form is available: HERE

This draft form was developed to support the future Trend Report in EUDAMED. However, it is being shared early to help manufacturers with trend reporting until EUDAMED is fully functional.

Until EUDAMED is ready, manufacturers should submit the form to the applicable Competent Authority according to MDCG 2021-1 (MDR) and MDCG 2022-12 (IVDR).

Once formally published, the MDR/IVDR version form will replace the MEDDEV version.

An MTR Help Text document will also be made available, to support manufacturers in filling out the form.

MDCG Guidance (Q&A) on Trend Reporting

The draft is available: HERE

Please note that it has not yet been formally published; hence the ‘MDCG 2025-X’ designation in the document. The final version may differ from the draft.

Topics covered include:

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Regulation	Type	Reason for the Trend	Possible Rationale
MDR	Increase in Frequency	Increase in frequency of skin rashes caused by adhesive patches.	A statistically significant increase in the frequency of non-serious incidents, compared to the stated frequency in the technical documentation, may indicate risks to patient safety that outweigh the intended benefits.
	Increase in Severity	Events of non-serious eye irritations from an ophthalmic device escalating to corneal abrasions.	A significant escalation in the severity of non-serious incidents suggests a deviation from the device’s benefit-risk analysis documented in the technical documentation and could result in unacceptable risks for the patient population.
	Increase in Frequency or Severity of Expected Undesirable Side Effects	Events of abdominal pain and nausea events after implantation of a contraceptive coil.	A statistically significant increase in the frequency or severity of expected undesirable side effects, compared to anticipated levels in the technical documentation, results in an unacceptable risk for the intended patient population.
IVDR	Increase in Frequency	Rise in invalid results from a cholesterol assay, where invalid runs exceed 5% of total runs.	A statistically significant increase in invalid results impacts the performance of the device when compared to the documented performance specifications.
	Increase in Severity	False-positive results from a vitamin B12 deficiency test leading to unnecessary injections.	An increase in the severity of erroneous results affects the benefit-risk analysis, by exposing patients to unnecessary interventions.
	Increase in Frequency or Severity of Expected Undesirable Side Effects	Increase in false-negative results from a urine protein test, causing delays in identifying early-stage kidney dysfunction.	A statistically significant increase in the frequency of expected erroneous results when compared to its stated performance, leads to unacceptable risks for the broader patient population.

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Manufacturer Trend Report Document

The draft version is available: HERE

Manufacturers should use this document to provide additional details that cannot be entered into the MTR form.

It includes four sections:

The template provides both practical (e.g., how to submit before EUDAMED is functional) and technical (e.g., type and level of information expected) guidance.

Serious Incident & FSCA Reporting

The meeting minutes note that: