RunaReg maps your technical file to MDR 2017/745, surfaces compliance gaps clause-by-clause, and drafts evidence-backed remediation for your review. A qualified human makes every regulatory decision — RunaReg makes that decision defensible.
EU 2026/977 — Türkiye CE-mark cutoff
Devices marketed in Türkiye with CE marks granted before 1 February 2027 fall under the EU 2026/977 alignment obligations, due 1 November 2027.
MDD → MDR transition window closes
Legacy MDD certificates expire. Devices without MDR conformity cannot remain on the EU market after the transition window closes.
Most teams keep the regulation in PDFs, the evidence in folders, and the reasoning in someone's head. RunaReg keeps all three connected: a versioned regulatory knowledge graph, an evidence vault with provenance, and an audit trail that records every decision you make.
Three checkpoints from regulation text to a reviewable finding. The same input always produces the same clause link.
MDR 2017/745, Annexes II / III / VIII / XIV, MDCG guidance, harmonized standards — versioned in a 1,100+ node regulatory knowledge graph with checksummed sources.
Each clause is linked to the matching paragraph in your technical file. Every match is reproducible and the trace is exposed for review.
Your PRRC or consultant approves remediation. Nothing exits the platform without a human regulatory owner.
RunaReg applies deterministic clause mapping first. Draft remediation remains review-only and never replaces a qualified regulatory owner.
What changes when your output has to be reproducible at audit — not just persuasive on screen.
We label jurisdiction depth the way we'd want a supplier to label it for us: Full where the graph is complete, Preview where coverage is early. No padded checklists.
All 23 GSPRs, Annex VIII classification rules, complete Annex II/III technical-file structure, and the MDD legacy bridge.
FullEarly coverage: 20 Annex I GSPR clauses and IVDR classification rules 1–3 with Class A fallback. Expanding.
PreviewEarly coverage: 15 curated UK MDR 2002 conformity requirements.
PreviewOur deepest overlay in progress: 55 curated TİTCK requirements aligned with the EU 2026/977 window.
PreviewTier labels are sourced from the same coverage census our platform reports internally.
No. RunaReg structures the evidence, findings, and remediation workflow. A qualified human reviewer remains the regulatory owner and decision-maker.
The same file and the same rule set produce the same clause link. The platform does not guess — it applies predefined matching logic and exposes the trace for review.
Yes. The platform is designed for pre-submission readiness, gap identification, and remediation planning before a Notified Body starts the formal clock.
Customer application data and working documents are processed and stored in the EU (Frankfurt, europe-west3), with row-level tenant isolation and an ALCOA+ oriented audit log. See the Trust & Security page for the full picture, including what we do and don't claim.
Generic AI tools answer from training-time corpora. RunaReg answers from a versioned regulatory knowledge graph — MDR, MDCG guidance, and harmonized standards represented as nodes and clause links, rebuilt on every regulation update. The platform then checks each AI-drafted sentence against the graph: does the clause exist as a node? Does the cited standard? Is the evidence in your file? Same input, same graph version, same answer.
No. RunaReg helps you prepare technical documentation and registration-ready data before you interact with EUDAMED. It does not submit to EUDAMED and does not replace your own submission workflow.
Tell us your device class, submission stage, and current bottleneck. We reply directly to coordinate access — no automated drip, no demo theatre.
Share your name, email, company, and device class. We follow up within one working day to coordinate access.