EU MDR & IVDR literature reviews — systematic, auditable, on schedule

The problem regulatory and clinical affairs teams face

• EU MDR 2017/745 and IVDR 2017/746 make literature reviews a recurring legal obligation: clinical evaluation, post-market surveillance, and PMCF updates all require fresh, documented evidence.
• MEDDEV 2.7/1 rev 4 expects a reproducible, documented search: databases, search strings, dates, inclusion and exclusion criteria, and an appraisal trail a notified body can audit.
• Traditional regulatory workflow managers track tasks but generate nothing: the search, screening, and write-up remain weeks of manual work per device, per cycle.
• Generalist AI chatbots fabricate citations — an unacceptable risk in a document a notified body will scrutinize.

What AutoSearch delivers

• Reproducible search strategy: databases, query strings, dates, and record counts exported with every report.
• PRISMA 2020 flow diagram documenting identification, screening, and inclusion.
• DOI verification against the Crossref API: zero fabricated citations by construction — a citation either resolves to a real bibliographic record or it is flagged.
• Semantic relevance check: every cited source is verified for relevance to the claim it supports.
• Audit trail and reproducibility statement aligned with RAISE reporting guidance.
• European data residency: UK and Swiss infrastructure, GDPR-aligned processing, no training on your files.
• IMRAD output with LaTeX/PDF export, ready to attach as the literature review appendix of your CER or PER.

Built for MEDDEV 2.7/1 rev 4 workflows

How AutoSearch maps onto the literature search requirements your notified body checks:

• Documented search protocol: databases, terms, dates → Search strategy export with sources, query strings, and record counts
• Reproducible, objective selection of literature → PRISMA 2020 flow diagram with explicit identification, screening, and inclusion counts
• Verifiable references → Live DOI verification via the Crossref API; unresolved citations are flagged, never invented
• Appraisal of relevance and contribution of each source → Semantic relevance verification linking each citation to the claim it supports
• Repeatable reviews for PMS and PMCF cycles → Re-run the same protocol on demand; audit trail and reproducibility statement included

Frequently asked questions

Does AutoSearch replace the clinical evaluator or the PRRC?

No. AutoSearch supports the literature review process. Clinical and regulatory responsibility remains with the manufacturer, the clinical evaluator, and the person responsible for regulatory compliance (PRRC). Every output is designed for expert review, not to bypass it.

Which databases are searched?

The scientific source pack queries PubMed, OpenAlex, Crossref, ClinicalTrials.gov, Semantic Scholar, and further scholarly indices. The exact source list and record counts are documented in every report.

How do you prevent fabricated citations?

Every DOI is verified live against the Crossref API before it enters the report. A citation that does not resolve to a real bibliographic record is flagged and excluded, so fabricated references are impossible by construction.

Can I reuse the search for PMS and PMCF updates?

Yes. The search protocol is exported with the report and can be re-run on demand, which is exactly what recurring post-market surveillance and PMCF literature updates require.

Is AutoSearch certified for MDR or IVDR compliance?

No software can be 'MDR certified', and we make no conformity claim. AutoSearch produces systematic, documented, verifiable literature reviews that you integrate into your own quality management system and technical documentation.

Scope and responsibility

AutoSearch supports the literature review process for clinical and performance evaluation. It does not provide regulatory advice and does not replace expert judgment. Clinical and regulatory responsibility for the device, the CER/PER, and conformity with EU MDR 2017/745 and IVDR 2017/746 remains with the manufacturer and its qualified persons, including the PRRC.