PMS, PMCF & PSUR Writing
Post-Market Documentation That Connects Back to Your CER
For companies that need post-market documentation structured to meet EU MDR Annex XIV requirements — and connected to the clinical evidence, benefit-risk conclusions, and PMCF objectives in the CER.
Who This Is For
When You Need Post-Market Writing Support
First PMCF plan under EU MDR
Your device needs a Post-Market Clinical Follow-up Plan that goes beyond stating "literature review" — with defined methodology, endpoints, data sources, and justification that satisfies Notified Body review.
PMCF plan flagged by the NB
Your Notified Body has questioned your PMCF methodology, the justification for chosen activities, or the connection between PMCF objectives and residual risks. The plan needs structured revision.
Annual PSUR update
Your Periodic Safety Update Report is due. It needs to synthesise post-market data, connect findings to the benefit-risk profile, and align with the current CER — not simply present data.
PMS documentation gap
Your PMS system is in place but the written documentation — PMS Plan, PMS Report — does not meet the structure or evidence standards required under EU MDR Annex III.
Document Types
Post-Market Documents We Write
PMS Plan
Defines the systematic approach to gathering and analysing post-market data. Must specify methods, sources, frequency, and how data connects to safety and performance objectives.
PMS Report (or PSUR)
PMS Report for Class I; PSUR for Class IIa, IIb, and III. The PSUR is not a data summary — it is a structured argument that the benefit-risk balance remains acceptable.
PMCF Plan
Specifies PMCF activities — literature review, registry participation, surveys, clinical investigations — with documented methodology and justification. Generic plans are routinely flagged.
PMCF Evaluation Report
Analyses the data gathered through PMCF activities against the endpoints defined in the PMCF Plan. Conclusions must feed back into the CER benefit-risk section.
What We Deliver
PMS / PMCF / PSUR Deliverables
Post-market documentation must not exist in isolation. PMS data, PMCF outputs, and PSUR conclusions must connect back to the CER benefit-risk analysis — and inform the next CER update cycle. We build that connection into the documentation structure.
Documentation structured to align with your annual CER update cycle and Notified Body surveillance schedule.
Included
- PMS Plan — systematic approach to collecting, evaluating, and analysing post-market data
- PMS Report — analysis of post-market data against the objectives defined in the PMS Plan
- PMCF Plan — with justified methodology, defined endpoints, and documented data sources
- PMCF Evaluation Report — analysis of PMCF data connected back to the CER
- PSUR — periodic safety update connecting post-market evidence to benefit-risk conclusions
- Annual update cycle planning — documentation schedule aligned to CER review cycle
Our Approach
How We Write Post-Market Documentation
Post-market documentation starts with the CER — not the other way around. Before writing a PMCF Plan or PSUR, we understand the benefit-risk conclusions, residual risks, and clinical claims the post-market data must support.
CER Review
We start by reading the current CER — the clinical claims, benefit-risk conclusions, residual risks, and intended purpose. Post-market documentation must connect back to these, not stand alone.
Evidence Gap Identification
We identify what post-market data is available — complaints, literature, registry data, surveys, PMCF outputs — and what is missing against the PMCF objectives and PSUR requirements.
PMCF Methodology Design
We design PMCF activities with defined methods, justified selection, measurable endpoints, and clear connections to residual risks. Vague methodology is the single most common PMCF finding.
Document Writing
We write structured, audit-ready post-market documentation — PMS Plan, PMCF Plan, PMCF Evaluation Report, PSUR — in a format designed to satisfy MDR Annex XIV and Notified Body review.
CER Feedback Loop
We ensure post-market data conclusions feed back clearly into the next CER update. PMS/PMCF findings that do not inform the CER create lifecycle coherence gaps — we close them.
Related Services
Post-market documentation connects directly to the CER and, when NB questions arise, to the response package.
Ready to plan your post-market documentation?
Tell us your device class, current PMS/PMCF status, and when your next PSUR or CER update is due.