Agent skill · research science · borghei
mdr-745-specialist
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Use for Annex VIII classification, GSPR, clinical evaluation, EUDAMED, and UDI.
Why this skill is useful
Provides detailed compliance workflows and documentation templates specific to EU MDR 2017/745 that the AI wouldn't reliably generate on its own.
What it needs
About 12k tokens when loaded. Last updated 2026-07-21. 462 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 --- Clarify First Before classifying the device or analyzing gaps, confirm these inputs. If any is unknown or vague, ASK — do not assume: [ ] Device characteristics — duration, invasiveness, body-system contact, and whether it is active/software (drives the Annex VIII classification) [ ] Intended purpose — the device's claimed clinical purpose (sets the applicable rule and clinical-evidence level) [ ] Software/AI nature — whether it is software as a medical device (MDCG 2019-11) or AI/ML (changes classification and the documentation set) Stop rule: ask only the 2-3 that most change the output. If the user says "just draft it," proceed and list your assumptions at the top of the classification. 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. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills borghei/mdr-745-specialist