IVDR performance evaluation literature review
The IVDR Performance Evaluation Report needs a systematic literature review for scientific validity and clinical performance. AutoSearch produces it — PRISMA-grade, DOI-verified, reproducible — in an afternoon instead of weeks.
Built in Switzerland · Crossref-verified citations · 0 fabricated DOIs in our public benchmark
Under the EU IVDR, the Performance Evaluation Report (PER) must document scientific validity, analytical and clinical performance — and the scientific-validity part rests on a systematic literature review. Dedicated IVDR content and tooling are scarce (most of the market still targets MDR), so the bar to stand out is low. AutoSearch automates the search, screening and PRISMA documentation the PER expects, with sources you can verify.
Scientific validity, documented
AutoSearch searches OpenAlex, Crossref, PubMed, Semantic Scholar and ClinicalTrials.gov in parallel, screens each record with a recorded decision, and outputs a PRISMA 2020 flow, an evidence matrix, inline citations and an exportable screening log — the literature-review evidence base for the scientific-validity and clinical-performance sections of the PER.
First-mover on IVDR, MDCG 2020-1 ready
Because dedicated IVDR/PER resources are still thin, a precise, current page plus a working tool wins the niche. For IVD software (SaMD), the same engine supports an MDCG 2020-1-aligned scientific-validity search.
Reproducible for ongoing performance follow-up
Performance evaluation is continuous. AutoSearch stores the search protocol so you re-run it for post-market performance follow-up (PMPF) on a fixed cadence and review only what is new.
| PER requirement | How AutoSearch helps |
|---|---|
| Scientific validity literature review | Systematic multi-database search with documented protocol. |
| Documented screening | Recorded keep/discard reason per record; exportable CSV log. |
| PRISMA flow & evidence base | PRISMA 2020 flow and typed evidence matrix generated automatically. |
| Verifiable sources | Every DOI live-checked against Crossref; 0 fabricated in benchmark. |
| Reproducibility for PMPF | Stored protocol re-runs on a fixed cadence for performance follow-up. |
Frequently asked questions
Does AutoSearch cover the IVDR Performance Evaluation Report?
It automates the literature-review evidence base for the scientific-validity and clinical-performance sections of the PER — systematic search, screening, PRISMA flow and evidence matrix. The regulatory authoring and conclusions remain yours.
Is it aligned with MDCG 2020-1 for IVD software?
The systematic, documented, reproducible search supports an MDCG 2020-1-aligned scientific-validity review for IVD software; you map the output to your PER structure.
Which databases does it search?
OpenAlex, Crossref, PubMed, Semantic Scholar, arXiv, ClinicalTrials.gov, DBLP and DOAJ, in parallel.
Are the citations verified?
Yes. Every DOI is checked live against Crossref; our public benchmark reports 0 fabricated DOIs across hundreds of references.
How much does it cost?
From CHF 29/month (Researcher, 300 credits) or one-time credits; a standard review is about 8 credits, with 50 free starter credits on signup.
Build your IVDR performance evaluation literature review
Write one research question and AutoSearch returns a PRISMA-grade, DOI-verified review for the scientific-validity section of your Performance Evaluation Report.
Run a free review →