EU Medical Device Regulations
MDR & IVDR compliance, step by step.
A free educational platform for understanding EU Regulation 2017/745 (MDR) and 2017/746 (IVDR). Explore device classification, documentation requirements, and practice with interactive compliance templates.
For learning and orientation only. Not regulatory, legal, or quality management advice. Full disclaimer
Learn
Regulations
Understand the EU MDR and IVDR frameworks — scope, key obligations, classification rules, conformity assessment routes, and timelines.
Interactive wizard
Classification
Walk through MDR Annex VIII or IVDR Annex VIII classification rules. Answer questions about your device to determine the applicable class.
87 templates
Documentation
Guided intake for company and product compliance. Explore roadmaps, browse the template library, fill in practice drafts, and export to DOCX or PDF.
Legal notice
Disclaimer & References
Educational purpose only. Source attribution, scope notes, limitation of liability, and third-party content notices.
Learning path: company
Understand the system first
- Learn how the legal role determines which MDR obligations apply.
- Explore QMS core: document control, CAPA, audits, complaint handling.
- Understand outsourced processes and supplier controls.
- See how notified body readiness connects to portfolio risk class.
Learning path: product
Explore the dossier per device
- Learn how intended purpose and classification drive the documentation route.
- Walk through the core technical file: GSPR, risk management, clinical evaluation.
- See when software, usability, PMCF, or PSUR documents are required.
- Understand how post-market updates keep the technical file current.