CERs that actually defend the claim.
Clinical Evaluation Reports under MDR/MEDDEV 2.7/1 Rev 4 — built from your literature corpus, equivalence rationale, and post-market surveillance data. Asthra structures the appraisal, drafts the narrative, and cites every inclusion decision.
The evidence package, indexed.
CERs draw on a wider source set than CSRs. Asthra accepts and tags every input, then keeps the appraisal traceable.
Literature search results
Embase, Medline, Cochrane output with PRISMA-style flow. Asthra captures search strategy and supports duplicate screening.
Appraisal worksheets
Quality grading per MEDDEV 2.7/1 Rev 4 Appendix A6/A7 — pivotal, supportive, or excluded.
Equivalence rationale
Technical, biological, and clinical comparison vs. equivalent device(s). Asthra structures §3 against the regulation's three pillars.
Risk Management File
ISO 14971 hazards, risk-control measures, and benefit-risk reasoning — flow through to §7 of the CER.
PMS / PMCF data
Post-market surveillance reports, vigilance data, registry output. Integrated into §10 conclusions and updates.
Prior CER
For continuity of clinical-evaluation history and traceable change-tracking between cycles.
From search lock to MDR-aligned draft.
Lock the search and load the corpus
Drop your literature search export, appraisal grid, equivalence rationale, RMF, and PMS data. Asthra reconciles PMIDs, dedupes, and flags any items not yet appraised.
Approve the appraisal map
Asthra produces a section-by-section evidence map: which study supports which CER claim. Reviewers swap, re-grade, or exclude — every change recorded.
Draft the CER body
§3 equivalence, §6 clinical evidence, §7 risk-benefit, §10 conclusions — drafted to MEDDEV 2.7/1 Rev 4 structure. Each claim cites a graded study with PMID and excerpt.
Clinical evaluator review
The qualified evaluator reviews in Word — challenges grading, refines benefit-risk language, integrates PMS findings — with Asthra surfacing the exact evidence each time.
Notified-Body submission
Final CER ships with the audit ledger embedded — including the appraisal trail. Notified-body reviewers can verify any claim back to its source on click.
What changes for the clinical-evaluation team.
Manual CER drafting
- −10–16 weeks per CER cycle, longer for high-risk classes
- −Appraisal grid maintained separately from the narrative
- −Equivalence rationale rewritten cycle after cycle
- −PMS data retrofitted into the document at the end
- −Notified-body queries answered via email and tracked separately
CER drafting with Asthra
- +Draft cycle compressed to weeks, not months
- +Appraisal grid and narrative are one connected artifact
- +Equivalence reasoning regenerates against new evidence
- +PMS data integrated from the first draft
- +NB queries answer themselves — every claim has its citation
Pilot Asthra
on a real CER.
30-day pilot. One device, one indication. We benchmark Asthra's draft against your existing process — search to NB submission.