$347 — Premium Tier

Post-Market Clinical Follow-up Study Design Toolkit: EU MDR Templates

PMCF Study Design Toolkit — PMCF study design guide, observational study protocol, registry study template, patient-reported outcomes methodology, PMCF data analysis plan, and results reporting template.

Get the Toolkit — $347

7-day money-back guarantee • One-time purchase • Instant download

What's Included

PMCF Study Design Selection Guide (EU MDR Annex XIV)
Observational Post-Market Study Protocol Template
Device Registry Study Protocol Template
Patient-Reported Outcomes (PRO) Methodology Template
PMCF Data Analysis and Statistics Plan
PMCF Results Reporting Template (EU MDR Article 61)

Benefits

Study design guide selects appropriate PMCF design based on device class and evidence gaps
Observational study protocol covers all EU MDR Annex XIV Part B required plan elements
Registry protocol covers design, data governance, and statistical methodology
PRO methodology covers validated instrument selection and clinically meaningful difference thresholds

Is This For You?

This toolkit is designed for teams facing these challenges:

Notified body rejecting PMCF plan as lacking study design specificity
No validated instrument selected for patient-reported outcome endpoints
PMCF data analysis plan missing statistical methodology for performance confirmation
PMCF results not structured for inclusion in clinical evaluation update

Who This Is For

Clinical affairs teams designing EU MDR PMCF studiesRA managers responsible for CE marking maintenanceDevice manufacturers building PMCF evidence for Class IIb and III devicesContract research organizations supporting PMCF study design

Frequently Asked Questions

What types of studies qualify as PMCF?

PMCF includes systematic literature reviews, registry participation, observational post-market studies, user surveys, and structured clinical data collection. The study type must be justified in the PMCF plan based on the specific clinical evidence gaps identified.

What format are the documents?

All documents are editable Word and Excel templates.

Related Toolkits

EU MDR PMCF

$347

CER Literature Review

$347

Post-Market Surveillance

$247

Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $347

7-day money-back guarantee