Clinical evaluation report cost
Most of a CER invoice is specialist time. The literature search is a large, repeatable share of that time. That share has a software price. The benefit-risk conclusion does not.
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A clinical evaluation report is quoted like a consulting project because most of it is hours. Published fee schedules — not a quote from us — put literature-inclusive packages at about USD 7,000 to USD 16,000 by device class, and full clinical evaluations are discussed from about GBP 15,000, with working writers describing projects from a few thousand dollars to above USD 50,000. Confirm the current schedule before you budget. A large share of that invoice is the literature review, and the requirements are written in MEDDEV 2.7/1 rev 4.
What the invoice is actually for
Public fee pages split the work into literature search and reporting, risk and PMS review, PMCF, and notified-body responses. A schedule posted for literature search plus the surrounding safety review runs from about USD 7,000 on lower-risk classes to about USD 13,000–16,000 when notified-body responses are included. Clin-R has described a full clinical evaluation as starting around GBP 15,000. CiteMed has written about quotes that run from a few thousand dollars to above USD 50,000. You are buying hours of searching, screening, tabulating and drafting, plus clinical judgement.
The part software can carry
MEDDEV 2.7/1 rev 4 and MDR Article 61 expect a systematic, reproducible literature search: a protocol, more than one source, recorded selection decisions, and a report a notified body can follow. AutoSearch runs that pass across PubMed, OpenAlex, Crossref, Semantic Scholar, arXiv and ClinicalTrials.gov, stores the protocol, records a decision per record, draws the PRISMA 2020 flow from those counts, and keeps only citations whose DOI resolves on Crossref. A standard review is about 8 credits. Researcher is CHF 29/month.
The part you should still pay a person for
AutoSearch does not write the benefit-risk conclusion, the equivalence argument, or the replies to a notified body. It does not replace a CER writer. AutoSearch does not search Embase: Embase is licensed, and if your notified body expects that arm you run it and file it beside the protocol. The output is a draft for the regulatory specialist who signs the CER. That split is how teams cut the writing invoice without pretending a model is the clinical evaluator.
Why the cost comes back every year
PMCF literature surveillance is the same search, later. A writer invoices it again. A stored protocol is re-run, and the new report is what changed. Teams on the Lab plan at CHF 290/month still spend less on the literature slice than one annual consulting update at the published fee levels above. The clinical reading of that new evidence stays human.
| Cost line | What changes with software |
|---|---|
| Literature search and screening | The recurring hours. AutoSearch runs a standard review for about 8 credits, on a plan from CHF 29/month. |
| PRISMA flow and search log | Often assembled by hand at the end. Generated from the run. |
| State of the art and device-specific draft | A first draft with citations that resolve on Crossref. A person edits it. |
| Equivalence, benefit-risk, notified-body answers | Unchanged. This stays with your clinical evaluator or your writer. |
| Embase or another licensed database | Unchanged. AutoSearch does not search Embase. |
| Next year's PMCF update | A new consulting invoice, or a re-run of the same protocol. |
Frequently asked questions
How much does a clinical evaluation report cost?
Public fee schedules put literature-inclusive packages at about USD 7,000 to USD 16,000 by device class, and full evaluations are discussed from about GBP 15,000, with some projects described above USD 50,000. Scope, device class and notified-body history move the number more than the template does. Those figures are other firms' published schedules, not an AutoSearch quote.
Can software replace a CER writer?
No. It carries the literature-search labour. You still need someone qualified to appraise the evidence, write the benefit-risk conclusion and answer the notified body. AutoSearch does not replace a CER writer.
Is the literature review aligned with MEDDEV 2.7/1 rev 4?
It produces the literature artifacts that guidance describes: a protocol, a multi-source search, recorded decisions, a PRISMA 2020 flow and an evidence matrix. Whether the CER as a whole meets the guidance is your responsibility. AutoSearch does not search Embase.
What does one literature review cost on AutoSearch?
A standard review is about 8 credits. Researcher is CHF 29/month with 300 credits, and registration includes 50 free credits, so the first reviews do not require a plan.
Does a cheaper literature review create notified-body findings?
Findings come from searches that cannot be repeated, from sources the protocol claimed to cover and did not, and from citations that do not exist. A stored protocol and a Crossref check reduce those findings. They do not appraise clinical data for you.
Price the literature review before you price the writer
Run the search on the free credits. Keep the writer for the clinical judgement, the equivalence argument and the notified-body replies.
Run the literature review →