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MDR
Device-Type Certification Tracks
End-to-end certification walkthroughs for specific device types — Class I through III, including SaMD.
- 1
Class I Device Certification
End-to-end walkthrough for a simple Class I device — from classification to CE marking.
15 minRequires: Classification Principles, Class I Self-Declaration - 2
Class IIa Device Certification
Certifying a mid-risk device: notified body involvement, documentation, and timelines.
16 minRequires: Classification Principles, Class IIa and IIb Routes - 3
Class IIb Device Certification
Higher-risk device pathway with full quality assurance or type examination options.
16 minRequires: Classification Principles, Class IIa and IIb Routes - 4
Class III Device Certification
The most rigorous path: design dossier examination, clinical evidence, and scrutiny procedure.
18 minRequires: Classification Principles, Class III Full Quality Assurance - 5
Software as a Medical Device (SaMD)
Classifying and certifying standalone medical software under the MDR.
18 minRequires: Classification Principles, Special Rules (14–22) - 6
Notified Body Selection and Audit
Finding the right notified body, preparing for audits, handling non-conformities, and maintaining certificates.
18 minRequires: Notified Bodies and Competent Authorities - 7
Market Placement and CE Marking
EU Declaration of Conformity, EUDAMED registration, CE marking, and market placement checklist.
16 minRequires: Notified Body Selection and Audit