Six documents for a defensible EU MDR system — procedure, root cause analysis, tracking log, effectiveness verification, trend metrics, and FDA audit prep.
Instant download. For QA managers at FDA-regulated device companies.
FDA QMSR §820.100 and ISO 13485 §8.5 require a documented EU MDR system covering investigation, root cause analysis, corrective and preventive actions, and effectiveness verification. The most common gaps: inadequate root cause investigation, missing effectiveness checks, and trend data not reaching management review.
This toolkit gives you the procedure, the forms, the RCA methods, the effectiveness protocol, and the FDA audit prep guide — everything needed to build a EU MDR system that holds up under inspection.
From problem identification through effectiveness verification and management review reporting.
Complete Annex II technical documentation structure template per EU MDR. Covers device description, design and manufacturing information, GSPRs, benefit-risk analysis, product verification and validation, and post-market surveillance plan. Pre-formatted for notified body submission.
Comprehensive EU MDR Annex I GSPR checklist with compliance methods for each requirement. Covers general requirements, design and construction requirements, and information supplied with the device. Includes standard references (EN ISO, IEC) and compliance evidence guidance.
Master technical file index template mapping all required documentation to Annex II sections. Includes document numbering system, revision control fields, and cross-reference to GSPR. Designed as a controlled document for audit readiness.
Mapping template linking QMS procedures to EU MDR Annex IX QMS requirements. Shows which ISO 13485 procedures satisfy which Annex IX obligations, reducing duplication and audit preparation time.
Complete pre-submission checklist for notified body conformity assessment. Covers application completeness, technical documentation completeness, QMS certificate requirements, and common deficiency areas that cause notified body queries.
SSCP template per EU MDR Article 32 for implantable and Class III devices. Covers intended purpose, device description, residual risks, clinical data summary, indications/contraindications, and lay person summary. Pre-formatted for EUDAMED upload.
The most common EU MDR failure FDA cites: fixing the symptom without identifying root cause. The RCA toolkit gives you five structured methods to get to the real cause every time.
FDA consistently flags EU MDRs closed without evidence of effectiveness. The effectiveness check protocol tells you exactly how to define, execute, and document a defensible verification.
ISO 13485 and QMSR both require EU MDR trend data at management review. The dashboard template is ready to populate — open/closed, cycle time, recurrence rate, source breakdown.
“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
An immediate correction (or containment) addresses the affected product or process right now — quarantine, rework, withdrawal. A EU MDR addresses root cause to prevent recurrence. FDA QMSR §820.100 requires both: you must correct AND investigate root cause for significant nonconformances. The EU MDR procedure template includes the decision tree for when each is required.
There is no regulatory timeframe — it must be risk-based. The toolkit includes a tiered cycle time framework based on nonconformance severity: critical (30 days), major (60 days), minor (90 days). FDA investigators look for EU MDRs open for an unreasonably long time and EU MDRs closed prematurely without effectiveness verification.
An effectiveness check is objective evidence that the EU MDR compliance actually prevented recurrence. FDA QMSR §820.100(a)(7) requires it. Timing depends on the action — typically 30-90 days after implementation. The effectiveness check protocol template covers method selection, success criteria, and documentation.
No. This is a practitioner reference toolkit. Consult your regulatory counsel for formal compliance opinions.
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Six documents. Instant download. FDA QMSR §820.100 + ISO 13485 §8.5.