Literature search protocol
A documented, reproducible search strategy with databases, search strings, inclusion/exclusion criteria, and PRISMA flow diagram — all present, or the CER does not release.
The most rigorous CER a medical device manufacturer can submit.
The CER Engine assembles a documentation-complete Clinical Evaluation Report — every required literature search, appraisal table, state-of-the-art synthesis, equivalence justification, benefit-risk conclusion, and PMCF/PSUR linkage — checked against MEDDEV 2.7/1 Rev.4 and MDCG 2020-13 before a qualified clinical evaluator signs.
Every element of MEDDEV 2.7/1 Rev.4PRISMA-traceable literature search logsMDCG 2020-13 template complianceQualified clinical evaluator sign-off5-business-day SLA
Why CERs fail
A single deficiency can stall your CE certificate for months.
A medical device's CE certificate is only as strong as its Clinical Evaluation Report. Miss a literature search step, skip a required appraisal, provide weak equivalence justification, or fail to link PMCF data — and the Notified Body issues a deficiency that adds months to an already 13–18-month queue.
Most manufacturers outsource CERs to per-hour consultancies, paying $18k–120k+ per report, yet the clinical evaluation remains the single most common cause of NB review delays. For low-volume and legacy devices, the compliance cost is pushing manufacturers to discontinue products rather than maintain them.
The CER Engine exists to close that gap with a single, exhaustive standard applied identically to every device.
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CERs are the top deficiency driver in MDR technical files
The benchmark
Measured against the letter of MEDDEV 2.7/1 Rev.4 — section by section.
We do not summarize the guidance and hope. Every CER is scored against a versioned rule pack tied to the exact text of MEDDEV 2.7/1 Rev.4 and the MDCG 2020-13 template. These are the provisions each report is held to.
Appraisal of individual studies
Each included study is appraised for methodological quality using a recognized tool (e.g., CASP, SIGN), with appraisal tables and scores recorded.
State of the art synthesis
A structured synthesis of the current knowledge, including device-specific safety and performance data, summarized in evidence tables.
Equivalence justification
For devices claiming equivalence, a detailed comparison of technological, biological, and clinical characteristics with the predicate device, per MEDDEV 2.7/1 Rev.4 Annex I.
Benefit-risk conclusion
A clear, documented conclusion on the acceptability of the benefit-risk ratio, supported by the synthesized evidence and acceptance criteria.
PMCF and PSUR linkage
The CER is linked to the Post-Market Clinical Follow-up plan and the Periodic Safety Update Report, with a clear description of how PMCF data feed back into the evaluation.
How a CER is built
Intake to evaluator release, with deterministic gates the AI cannot overrule.
AI extracts and drafts. Deterministic rules — running as code, outside the model — decide what is complete. A qualified clinical evaluator signs every release. That order is never reversed.
01
Gap Scan
Upload the existing CER, device IFU, and NB deficiency letter. We return a free completeness read: which MEDDEV sections and MDCG template elements you already have, and which are missing.
02
Literature search & evidence retrieval
As your authorized clerical agent, we execute the PRISMA-traceable literature search, retrieve full-text articles, and build the evidence library.
03
Grounded drafting
The CER sections are drafted from your device data and the MEDDEV rule pack into field-locked templates — no legal opinions, no invented facts.
04
Deterministic completeness gates
Search strings are verified against the protocol; appraisal scores are checked; equivalence tables are reconciled; benefit-risk conclusion is validated against acceptance criteria. Any failure blocks release.
05
Qualified evaluator release
A qualified clinical evaluator reviews the exception queue, signs the CER, and provides CV and Declaration of Interest for NB scrutiny. High-risk or implantable devices route to a second evaluator.
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Delivery
You receive the CER package: signed report, search logs, appraisal tables, evidence library, CV/DOI, and a managed update calendar — ready for submission to your Notified Body.
The bar we hold
Rigor you can measure.
100%
Evaluator-signed
No CER ships without a qualified clinical evaluator's signature.
5 days
Standard SLA
From complete intake to released CER.
<1%
Critical-defect target
Tracked against a gold-standard CER library.
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Literature databases searched
PubMed, Embase, Cochrane, and device-specific registries, every applicable file.
Why the CER Engine
Built to be the most thorough option a manufacturer has.
Documentation-complete, by design
The deliverable is completeness itself — every MEDDEV section and MDCG template element accounted for or explicitly exception-coded. Nothing is left implicit.
Deterministic, not vibes
The gates that decide completeness are code, not a model's opinion. A drafting error cannot slip past a regulatory requirement.
In its lane, on purpose
We prepare documentation and run searches as your clerical agent. We never provide legal advice, make regulatory strategy decisions, or submit to Notified Bodies on your behalf.
Engagement
Flat fee, per released CER. No hourly billing, ever.
Simple, predictable, and aligned with a documentation standard — not a cut of any recovery.
- A free Gap Scan before you commit — see exactly what is missing.
- One flat fee per released CER; disclosed pass-through literature retrieval costs.
- Optional fixed-fee second evaluator review for high-risk or implantable devices.
- Optional Annual Update Subscription for managed CER refreshes on your required cadence.
FAQ
Questions, answered precisely.
Is the CER Engine a law firm or regulatory consultancy?
No. The CER Engine, a service of Your Deputy, Obuke LLC, provides documentation-completeness services. It is not a law firm, does not provide legal advice, and does not represent you before Notified Bodies. Qualified clinical evaluator review is available and recommended for all devices.
Do you submit the CER to the Notified Body?
No. The manufacturer remains responsible for all submissions. We deliver the complete, signed CER package for you to submit.
What makes a CER 'complete'?
Completeness is defined by MEDDEV 2.7/1 Rev.4 and MDCG 2020-13: a documented literature search protocol, PRISMA flow, appraisal tables, state-of-the-art synthesis, equivalence justification (if claimed), benefit-risk conclusion, and PMCF/PSUR linkage. Deterministic gates enforce each one before release.
How fast is it?
The standard SLA is five business days from complete intake to an evaluator-released CER. The free Gap Scan is returned much sooner and tells you exactly what is still needed.
How are you priced?
A flat fee per released CER, plus disclosed pass-through literature retrieval costs. No hourly billing and no percentage of any product revenue.
See what's missing before it costs you a certificate.
Start with a free Gap Scan. Send your existing CER, device IFU, and NB deficiency letter and we'll return a completeness read against every section of MEDDEV 2.7/1 Rev.4.
Documentation-completeness service · not legal advice · the manufacturer submits every report.