MDCG 2025-10｜From the Notified Body PerspectivePMSIn-depth Analysis (Practical Edition for Manufacturers)

Introduction｜Why You Need“the Notified Body Perspective”forPMSunderstanding

If you have gone throughNBan audit, you will discover a harsh but real fact:
Nonconformities are often not because you“did not do it”, but because——
you could not convince the assessor.

MDCG 2025-10Since then, the Notified Body's review ofPMShas changed significantly:
from“document cross-checking”, to“logical scrutiny”。

The objective of this article:
to help you see, from the Notified Body's perspective, what they are really thinking inPMSan audit, what they ask, and how they determine whether your“is effective or ineffective”。

1. How does a Notified Body“enter”yourPMSsystem?——FromPMS Planthe implementation

[NBperspective]
PMS Planis not a background document, but“a review roadmap”。
The auditor will assume:
“If this plan describes the real execution logic, following it will lead me to the evidence.”

[Typical follow-up questions]
• How did you choose which risks to monitor here?
• Why once a year for this product, instead of every six months?
• If the data is abnormal, who makes the call? Is there a process?

[Common nonconformities]
• PMS PlanToo generic; applicable to all products
• No explanation“why it was designed this way”
• Actual execution does not match the plan description

[Key company response points]
PMS PlanIt should be able to be“used as a flowchart”，
rather than a restatement of regulations.

II. How Notified Bodies See It“ProactivePMS”？

[NBreal logic]
The auditor will not ask you“conducted a few surveys”，
Instead, they will ask:
“If something goes wrong in real-world use, what enables you to know first?”

[Typical follow-up questions]
• Besides complaints, do you have any other signal sources?
• If there are no complaints, how do you confirm that the product truly has no issues?

[Common nonconformities]
• All data sources are passive
• using“market maturity”as the sole justification for not conducting proactive monitoring

[Key points for company response]
Even if there is only one proactive source,
as long as the rationale is clear and the frequency is appropriate,
that alone can significantly reduce audit risk.

III. Thresholds and Trends: What Notified Bodies Truly Care About“judgment capability”

[NBunderlying logic]
Without thresholds, there can be no judgment.
Without judgment, there can be no meaningful risk management.

[Typical follow-up questions]
• When do you consider this a“trend”？
• Why are you not taking action now?
• If it doubles next year, what would you do?

[Common nonconformities]
• “No safety issues have been observed”but there is no quantitative basis whatsoever
• All conclusions rely on undocumented expert judgment

[Key company action points]
The threshold is not meant to triggerFSCA，
but to make your“decision not to act”defensible。

4. PMCF: Why Notified Bodies are becoming increasingly harder to be“persuaded by exemption”rationales

[NB[The real logic]
Not conducting PMCFPMCFis acceptable,
but only if:
“you already have continuous, sufficient, and explainable post-market evidence.”

[Typical follow-up questions]
• How do you continuously confirm safety and performance?
• Is the volume of post-market data truly sufficient?
• Where is the evidence of risk reduction?

[Common nonconformities]
• Only pre-market clinical evaluation is cited
• PMCFThe exemption rationale has not been updated for years

[Key company action points]
Rather than insisting on“doing nothing at allPMCF”，
it is better to design a“minimal but reasonable”PMCFPlan.

V.PMSThe ultimate review point: does the closed loop really exist

[NBThe real logic]
PMSNot to writePSUR，
but to change the product.

[Typical follow-up questions]
• When is the risk management file updated?
• Is the clinical evaluation still citing legacy data?
• CAPAWhy was it closed? What was the basis?
• Did the management review discuss these issues?

[Common nonconformities]
• PMSThe conclusion triggered no system action
• The documents do not reference one another, and the timeline is disorganized

[Key points for company response]
NBIt does not require you to“take action every time”，
but it does require you to“assess every time and leave evidence”。

6. How the Notified Body“reaches its conclusion”？——What kind ofPMSwill be considered valid

[InNBthe Notified Body's eyes, valid]PMSUsually includes]
• Plan and execution are aligned
• Data sources are proactively traceable
• The decision logic is explainable
• The decision path is documented
• The outputs genuinely affect risk, clinical, and product decisions

[One-sentence takeaway]
MDCG 2025-10It’s not about increasing workload,
it’s about increasing“the cost of being unable to explain”。

Closing Thoughts｜A candid word for compliance teams

If you're asking now:
“MyPMSWill it be approved?”

What the Notified Body will really ask is:
“If you were the regulator for this product, would you feel confident?”

Those who can answer that questionPMS，
are the ones who truly meetMDCG 2025-10compliance in the true sense.