The scene
Picture the regulatory affairs manager in a notified-body prep call before the PMS plan and clinical evaluation report update are reviewed. The team has complaints, literature notes, PMCF questions, vigilance checks, and management-review slides, but the thread between them is hard to follow.
A useful PMS article does not declare the file acceptable. It helps the team prepare the evidence trail so the qualified RA/QA, clinical, and notified-body-facing reviewers can inspect the logic.
Source ledger workflow
- EU MDR source text: which PMS, vigilance, clinical, or technical-documentation question it informs.
- MDCG guidance: which preparation question it helps frame and where interpretation remains open.
- Internal record: complaint trend, PMCF note, CER section, risk-file update, vigilance assessment, or management-review action.
- Owner and next action: who validates the record, what is missing, and when it returns for qualified review.
Evidence-thread map
| Thread element | Question to answer |
|---|---|
| Trigger | Why is the PMS file being reviewed now? |
| Public source | Which EU MDR or MDCG source frames the question? |
| Internal evidence | Which record supports or challenges the current narrative? |
| Gap | What evidence, owner, or rationale is missing? |
| Decision boundary | Which conclusions remain with qualified reviewers? |
Source ledger
What it can tell you
EU MDR source text for postmarket surveillance, vigilance, clinical evaluation, and related manufacturer obligations.
What it cannot decide
Whether a specific PMS plan, PSUR, PMCF plan, clinical evaluation update, or technical file is acceptable.
What it can tell you
European Commission medical-device sector context, including implementation resources and public guidance locations.
What it cannot decide
How a specific notified body will assess one manufacturer's PMS evidence thread.
What it can tell you
Public MDCG guidance references that may inform PMS, PMCF, clinical, vigilance, and technical-documentation preparation.
What it cannot decide
Which guidance interpretation controls a specific device, claim, classification, or conformity-assessment file.
Frequently asked questions
Can this determine whether a PMS plan will satisfy a notified body?
No. It organizes evidence and open questions. Acceptability, conformity-assessment, clinical, legal, and regulatory conclusions remain with qualified reviewers and the notified-body process.
What is the first useful output?
A PMS evidence-thread map with source links, internal record IDs, owner assignments, gaps, and next review questions.
Need an EU MDR PMS evidence thread before the review call?
Send the product family, PMS trigger, and open reviewer question. We can scope a source-backed evidence thread for qualified review.
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