Agent skill · research science · alirezarezvani
mdr-745-specialist
Use for EU MDR 2017/745 work: device classification under Annex VIII, technical file gaps (Annex II/III), clinical evaluation, PMS and PSUR cadence, notified body prep. Checks the file with mdr_gap_analyzer.py.
Why this skill is useful
Provides specific classification workflows and documentation requirements for medical devices under EU MDR that the AI wouldn't reliably generate on its own.
What it needs
About 6k tokens when loaded. Last updated 2026-08-05. 23,939 stars on the source repository.
What this skill does
MDR 2017/745 Specialist EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence. --- Table of Contents Device Classification Workflow Technical Documentation Clinical Evidence Post-Market Surveillance EUDAMED and UDI Reference Documentation Tools --- Device Classification Workflow Classify device under MDR Annex VIII: 1. Identify device duration (transient, short-term, long-term) 2. Determine invasiveness level (non-invasive, body orifice, surgical) 3. Assess body system contact (CNS, cardiac, other) 4. Check if active device (energy dependent) 5. Apply classification rules 1-22 6. For software, apply MDCG 2019-11 algorithm 7. Document classification rationale 8. Validation: Classification confirmed with Notified Body Classification Matrix Factor Class I Class IIa Class IIb Class III -------- --------- ----------- ----------- ----------- Duration Any Short-term Long-term Long-term Invasiveness Non-invasive Body orifice Surgical Implantable System Any Non-critical Critical organs CNS/cardiac Risk Lowest Low-medium Medium-high Highest Software Classification (MDCG 2019-11) Information Use Condition Severity Class ----------------- ------------------- ------- Informs decision Non-serious IIa Informs decision Serious IIb Drives/treats Critical III Classification Examples Example 1: Absorbable Surgical Suture Rule 8 (implantable, long-term) Duration: > 30 days (absorbed) Contact: General tissue Classification: Class IIb Example 2: AI Diagnostic Software Rule 11 + MDCG 2019-11 Function: Diagnoses serious condition Classification: Class IIb Example 3: Cardiac Pacemaker Rule 8 (implantable) Contact: Central circulatory system Classification: Class III --- Technical Documentation Prepare technical file per Annex II and III: 1. Create device description (variants, accessories, intended purpose) 2. Develop labeling (Article 13 requirements, IFU) 3. Document design and manufacturing process 4. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills alirezarezvani/mdr-745-specialist--d9aed3