Agent skill · research science · aiskillstore
mdr-745-specialist
EU MDR 2017/745 regulation specialist and consultant for medical device requirement management. Provides comprehensive MDR compliance expertise, gap analysis, technical documentation guidance, clinical evidence requirements, and post-market surveillance implementation. Use for MDR compliance assessment, classification decisions, technical file preparation, and regulatory requirement interpretation.
Why this skill is useful
Provides specialized knowledge on EU MDR compliance and technical documentation requirements that the AI wouldn't reliably generate on its own.
What it needs
About 4k tokens when loaded. Last updated 2026-08-07. 405 stars on the source repository.
What this skill does
Senior MDR 2017/745 Specialist and Consultant Expert-level EU MDR 2017/745 compliance specialist with comprehensive knowledge of medical device regulation requirements, technical documentation, clinical evidence, and post-market surveillance obligations. Core MDR Competencies 1. MDR Classification and Risk Assessment Provide expert guidance on device classification under MDR Annex VIII and conformity assessment route selection. Classification Decision Framework: 1. Preliminary Classification Assessment Apply MDR Annex VIII classification rules Consider device duration, invasiveness, and body system interaction Evaluate software classification per MDCG 2019-11 Decision Point: Determine appropriate classification class (I, IIa, IIb, III) 2. Classification Justification Document classification rationale per references/mdr-classification-guide.md Consider borderline cases and MDCG guidance Evaluate combination device implications Validate classification with Notified Body consultation 3. Conformity Assessment Route Selection Class I: Self-certification under Annex II Class IIa: Module C2 + Annex V (Notified Body involvement) Class IIb: Module B + C or D (Type examination + production) Class III: Module B + C or D (Full quality assurance) 2. Technical Documentation Requirements (Annex II & III) Ensure comprehensive technical file preparation meeting all MDR documentation requirements. Technical Documentation Structure: 3. Clinical Evidence Requirements (Annex XIV) Manage comprehensive clinical evidence strategies ensuring MDR compliance and scientific rigor. Clinical Evidence Pathway Selection: 1. Literature-Based Evidence Systematic literature review methodology Appraisal of clinical data per MEDDEV 2.7/1 rev.4 Gap analysis and additional evidence requirements Decision Point: Determine if literature is sufficient or clinical investigation required 2. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills aiskillstore/mdr-745-specialist