$347 — Premium Tier

Clinical Evaluation Report (CER) and Literature Review Toolkit: EU MDR Templates

Clinical Evaluation Report (CER) and Literature Review Toolkit: EU MDR Templates - complete templates for EU MDR clinical evaluation compliance.

Get the Toolkit — $347

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

What's Included

Clinical Evaluation Plan (CEP) Template (EU MDR Article 61 + MEDDEV 2.7.1 Rev 4)
Clinical Evaluation Report (CER) Structure Template
Literature Search Protocol (PubMed/EMBASE Methodology)
Clinical Data Appraisal Worksheet
Equivalence Assessment Template (EU MDR Annex IX)
Clinical Evaluation Update (PCCP) Schedule

Benefits

MEDDEV 2.7.1 Rev 4 compliant CER structure
Reproducible literature search protocol satisfies notified body requirements
Equivalence assessment template covers EU MDR Annex IX
Saves 40+ hours vs building from scratch

Is This For You?

This toolkit is designed for teams facing these challenges:

Notified body rejecting CER for inadequate literature methodology
No structured equivalence assessment documentation
Literature search not reproducible or documented
CER update schedule undefined

Who This Is For

RA leads preparing CE marking submissionsClinical affairs managers responsible for clinical evaluationNotified body consultants supporting CER developmentStartups entering EU market for the first time

Frequently Asked Questions

Is this aligned with MEDDEV 2.7.1 Rev 4?

Yes, fully aligned with MEDDEV 2.7.1 Rev 4 and EU MDR Article 61 clinical evidence requirements.

What format are the documents?

All documents are editable Word/Markdown templates ready for direct use in CE marking submissions.

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Ready to Get Started?

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

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