Is it a device or an IVD? Which risk class? When's your deadline? Start here.
The MDR and the IVDR, made navigable — qualify and classify a device, evidence it against Annex I, and count down to transition. Switch between the two regulations any time with the toggle in the header.
Which one are you working with?
Pick a regulation to set the context for the whole site — or flip between them whenever you like using the MDR · IVDR switch in the header.
MDR — Medical devices
The core regulation for medical devices placed on the EU market — from scalpels and implants to medical-device software.
Regulation (EU) 2017/746IVDR — In vitro diagnostics
The regulation for in vitro diagnostic medical devices — tests run on samples taken from the body, from pregnancy tests to companion diagnostics.
From idea to CE mark, in six moves.
The practical path every product team walks to place a device on the EU market. Each step points to the articles and annexes that govern it.
Every chapter, article and annex — one click away.
The full structure of the active regulation, colour-coded by lifecycle phase and searchable by keyword or article number. Each item links straight to the official EUR-Lex text.
A growing course library.
From the legal landscape to the decisions every product team must make, to building a certifiable quality system — with more courses added over time. No legal background required.
Not just reading — working tools.
Qualify and classify a device, evidence it against Annex I, and count down to your deadline.
Qualification wizard
Is it a medical device at all? Device, accessory, Annex XVI, IVD or out of scope.
Annex VIIIClassification wizard
Work the Annex VIII rules — get an indicative class, the governing rule, and the conformity route.
Annex IGSPR matrix
Evidence each safety requirement; export your matrix to CSV.
Article 120Deadline calculator
Pick your device class and see a live countdown to the end of transition.
Saved locallyCompliance checklist
Track readiness across the lifecycle with a progress ring that remembers you.
Read the regulation with a map in hand.
This is a structured tour so that when you read the regulation itself, you know exactly what you're looking at. Cite the regulation — use the courses to understand it.
This is training material, not legal advice. The MDR and IVDR are amended periodically and notified-body interpretations evolve — verify any specific provision against the current Official Journal text before relying on it.