6 FDA + EU MDR compliant PMS templates. Ship a compliant post-market program without starting from scratch.
Instant download. For QA/RA at Class II and III device companies.
Under EU MDR, post-market surveillance is no longer a checkbox — it is a continuous, documented program with mandatory outputs: PMCF protocols, PSURs, PMS Summary Reports, and real incident reporting timelines. Notified bodies are issuing findings on missing or inadequate PMS documentation at unprecedented rates.
This toolkit gives you the document templates, SOPs, and decision frameworks to build a compliant PMS program from scratch — or bring an existing one up to MDR standard.
Structured in the order you would build a compliant post-market program.
ISO 13485 §8.2 + EU MDR Article 83 compliant PMS Plan covering surveillance objectives, methods, data sources, and review schedule. Pre-mapped to FDA 21 CFR 820.200 QMSR post-market requirements. Includes section instructions and NB/FDA auditor guidance.
EU MDR Annex XIV Part B compliant PMCF Protocol. Covers clinical rationale, objectives, methodology, literature review framework, registry approach, and PMCF evaluation report structure. Required for CE-marked Class IIa, IIb, and III devices.
EU MDR Article 86 compliant PSUR template with all required sections: device description, PMS conclusions, benefit-risk ratio update, sales volume data, serious incident analysis, and PMCF evaluation summary. Structured for annual NB submission.
Dual-jurisdiction SOP covering FDA 21 CFR 803 MDR reporting and EU MDR Article 87 serious incident reporting. Includes intake form, investigation workflow, 30/5-day reporting decision tree, and MDR/eMDR filing guidance.
Step-by-step FSCA decision framework per EU MDR Article 87 and FDA recall regulations. Covers recall classification, Field Safety Notice (FSN) template, competent authority notification, and effectiveness check documentation.
PMS Summary Report template for Class IIa/IIb devices per EU MDR Annex III. Covers device description, PMS data summary, conclusions on benefit-risk, any preventive/corrective actions taken, and NB submission checklist.
Templates are structured to meet the EU MDR Annex III and XIV requirements NB reviewers check for. Not generic ISO docs — MDR-specific section by section.
The complaint handling SOP maps directly to MDR reporting timelines (30-day, 5-day) and eMDR filing requirements under FDA. One SOP, both jurisdictions.
Every document is structured the way auditors and notified bodies expect to see them — with evidence references, section numbers, and audit-trail fields built in.
Most QMS tools stop at 510(k)/CE mark. This toolkit addresses what comes after — the continuous post-market obligations that keep your device on the market.
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“I built these templates from 12 years of running a Class II/III medical device manufacturing operation. Every document reflects what FDA investigators actually ask for — not what consultants think they ask for. We use these exact frameworks at AB Medical.”
Joshua Millage, CEO — AB Medical Technologies
“When you've been through enough FDA inspections, you learn what documentation gaps get flagged and which ones slide. These templates close the gaps that matter. We developed them alongside our own QMS buildout and they've held up under audit.”
Rick, Director of Engineering & Regulatory — AB Medical Technologies
PMS is the systematic process of collecting and analyzing data about your device after it reaches the market. Under EU MDR, it is mandatory for all CE-marked devices. Under FDA QMSR (effective 2026), post-market risk management and complaint analysis are required as part of the expanded QMS scope. If you sell in either market, you need a documented PMS program.
Under EU MDR, yes — unless you can justify why PMCF is not applicable. The PMCF Protocol or a documented PMCF rationale is required for Class IIa, IIb, and III devices. Notified bodies are increasingly rejecting blanket PMCF exemptions without strong clinical justification.
For Class IIb and III devices: annually. For Class IIa devices: every 2 years. The PSUR must be updated and available for NB review on this schedule. This toolkit includes a PSUR template structured for NB submission.
Class IIa and IIb devices submit a PMS Summary Report. Class IIb and Class III submit a PSUR. The PSUR has more detail on clinical data and the benefit-risk ratio. This toolkit includes both templates.
No. This is a practitioner reference toolkit built by regulatory professionals. Consult your regulatory counsel for formal compliance opinions specific to your device and markets.
Start with the right structure. Add your device-specific data. Satisfy both FDA and MDR.