Bundle — Save 75%
EU MDR Compliance Bundle
CER, PMCF, technical documentation, NB audit prep, and vigilance reporting — everything a US manufacturer needs to get through MDR certification.
$347$1,685 if bought separately
5 toolkits. One payment. Instant download.
Get the bundle — $347 →Instant download. 30-day refund if not useful.
What's included
✓CER & Literature Review Toolkit
$347CER template, literature search protocol, appraisal matrix, clinical data table, SSCP outline.
✓PMCF plan, PMCF evaluation report, survey templates, registry integration guidance.
✓EU MDR Technical Documentation Toolkit
$347Technical file structure, device description templates, clinical evidence summary, UDI/EUDAMED checklist.
✓Notified Body Audit Preparation Toolkit
$347NB audit readiness checklist, common findings list, mock audit agenda, document preparation guide.
✓MDR & Vigilance Reporting Toolkit
$297Serious incident criteria guide, FSCA decision tree, Competent Authority report template, trend reporting procedure.
Total value$1,685
Who it's for
→US manufacturers entering the EU market under MDR 2017/745
→EU manufacturers transitioning from MDD to MDR
→RA consultants building MDR technical documentation for clients
This bundle is for informational purposes only. Not legal or regulatory advice. Consult a qualified regulatory affairs professional for your specific situation.
RegWatchDaily · Legal · hello@regwatchdaily.com