The PSUR drafting moment
Picture the founder or RA/QA lead before a notified-body or consultant review. The team has complaint exports, PMS notes, CAPA references, risk-file updates, and clinical evidence fragments, but the story is not yet review-ready.
The useful move is to build a PSUR workpaper before writing polished prose. The workpaper should show source context, evidence families, source limits, owner decisions, and unresolved gaps.
PSUR workpaper checklist
| Workpaper section | What to capture |
|---|---|
| Scope | Device family, class context, reporting period, markets, PMS plan link, and intended reviewer. |
| Source ledger | Article 86, MDCG 2022-21, MDCG guidance page, PMS guidance context, access dates, and source limits. |
| Evidence inputs | Complaints, vigilance signals, trend review, CAPA links, risk-file updates, PMCF or clinical evidence links, exposure context, and prior PSUR decisions. |
| Open questions | Trend interpretation, benefit-risk questions, clinical evidence gaps, risk-control questions, and reviewer owner. |
| Draft boundary | Which conclusions belong to qualified RA/QA, clinical, regulatory, PMS, risk, legal, and notified-body-facing reviewers. |
What good looks like
A useful PSUR first draft makes it easy to review source support. It should not bury missing evidence under confident language. Each major statement should connect to a source, an internal evidence input, or an explicitly open question.
The strongest PSUR workpaper is not the longest one. It is the one where a reviewer can see the evidence path, source limitation, owner, and unresolved decision without reconstructing the file from memory.
Source ledger
What it can tell you
The European Commission announcement page for MDCG 2022-21 and its PSUR guidance document.
What it cannot decide
Whether one manufacturer's PSUR is complete, sufficient, or acceptable to a notified body.
What it can tell you
Guidance context for PSUR presentation and content under Regulation (EU) 2017/745.
What it cannot decide
A device-specific PSUR conclusion, trend interpretation, clinical conclusion, benefit-risk conclusion, or notified-body response.
What it can tell you
The official EU MDR regulation text, including Article 86 context for PSUR requirements.
What it cannot decide
How one device family, class, PMS plan, clinical file, or manufacturer workpaper should be accepted.
What it can tell you
Where European Commission medical-device guidance documents, including PSUR-related MDCG guidance, are listed.
What it cannot decide
Which guidance combination is sufficient for one manufacturer or one notified-body interaction.
What it can tell you
Recent MDCG PMS guidance context and its relationship to PSUR-specific guidance.
What it cannot decide
How a PSUR should be written for one device, one PMS data set, or one review cycle.
Frequently asked questions
Does this checklist write a compliant PSUR for my device?
No. It organizes source context, evidence inputs, and review questions. PSUR sufficiency, clinical conclusions, benefit-risk conclusions, and notified-body-facing positions remain with qualified reviewers.
What should I collect before drafting the PSUR narrative?
Collect the Article 86 and MDCG source ledger, reporting-period scope, PMS data inputs, complaint and vigilance summaries, CAPA and risk-file links, PMCF or clinical evidence links, prior decisions, and open reviewer questions.
Need a PSUR workpaper before reviewer time?
Send the device family, reporting period, and current PMS evidence question. We can scope a source-backed PSUR workpaper for qualified review.
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