Artifakt · Compass · Free EU MDR pathfinder
Map your EU MDR pathway.
Answer ~15 questions and get a preliminary Annex VIII classification, a roadmap to CE-marking, your applicable document inventory, a standards bibliography, a clinical strategy, and an indicative cost & timeline — grounded in real regulatory sources.
From a blank page to a defensible MDR pathway, without a consultant on day one.
01
Answer ~15 questions
A short, conditional wizard about your device — intended purpose, how it contacts the body, software, sterility, measuring function. No signup, no credit card.
02
Deterministic classification
Your answers run through the 22 MDR Annex VIII rules encoded as logic — no LLM in the decision path. You get a class and the exact rule that drove it.
03
Six-section strategic report
A founder-readable plan from QMS setup through CE-marking and post-market, narrated over the deterministic result and grounded in real regulatory sources.
Three things founders get wrong about MDR Annex VIII — and what Compass does about each.
01
Deterministic
Annex VIII classification by rule, not by guess. The 22 rules encoded as deterministic logic — the LLM only narrates, it never decides the class.
02
Grounded
Document inventory drawn from the same regulatory corpus the paid Artifakt Tech Doc generator uses. Real MDCG references, real harmonised standards.
03
Hedged
Outputs are preliminary. Every report carries the human-RA-review disclaimer, and Compass routes hard-rejection cases (custom-made, IVDR, Annex XV) to expert consultation.
One report. Six outputs. No shortcut to a clean MDR pathway.
01
Classification
Class + applicable Annex VIII rule + reasoning chain.
02
Regulatory roadmap
Phase plan from QMS setup through CE-marking and post-market.
03
Document inventory
Annex II/III docs that apply — pulled from the BPG V3 mapping.
04
Standards bibliography
Harmonised standards (ISO 13485, 14971, 15223-1) + state-of-the-art (IEC 62304, 81001-5-1, 62366-1).
05
Clinical strategy
Equivalence vs investigation vs PMCF-heavy decision tree, per class.
06
Cost & timeline
Indicative envelope per conformity route, with the NB-variance disclaimer.
Grounded in real regulatory sources — not generated.
MDR Annex VIII
All 22 classification rules, encoded verbatim and cross-checked against EUR-Lex and MDCG guidance.
MDCG guidances
Borderline & qualification guidance (MDCG 2019-15, 2021-24, 2022-5, 2023-5) surfaced per device profile.
Harmonised standards
EN ISO 13485, 14971 and 15223-1 — verified against the latest Commission Implementing Decision.
EUDAMED registry
89,623 EU-registered MDR devices ground the real-world class distribution and the comparable-device list.
Artifakt corpus · BPG V3
The same founder-curated document templates the paid Artifakt Tech Doc generator runs on.
Notified Body directory
MDR-designated Notified Bodies across the EU, surfaced whenever your route needs one.
Free · no signup
Get a preliminary regulatory pathway for your device in five minutes.
Compass writes a founder-readable report across the entire CE-marking journey, from QMS through post-market. No account, no credit card — the full PDF is email-gated only at the very end.
Compass is a sub-product of Artifakt — a living MedTech compliance system.