Mdr 745 Specialist
Structure EU MDR Annex XIV clinical evaluation and PMCF evidence plans before committing to a regulated medical-device software build.
Overview
mdr-745-specialist is an agent skill for the Validate phase that guides EU MDR Annex XIV clinical evaluation and post-market clinical follow-up evidence planning for medical devices.
Install
npx skills add https://github.com/alirezarezvani/claude-skills --skill mdr-745-specialistWhat is this skill?
- Clinical evidence framework with ranked evidence types from RCT through literature and expert opinion
- Class I–III minimum evidence matrix including when clinical investigation is typically required
- Clinical evaluation process aligned to MDR Annex XIV themes
- Literature-based evidence and equivalence pathways for established technology
- Post-market clinical follow-up (PMCF) guidance tied to ongoing obligation after launch
- 5-row evidence hierarchy table from RCT through expert opinion
- 4 device classes (I, IIa, IIb, III) with minimum evidence guidance
Adoption & trust: 711 installs on skills.sh; 17.5k GitHub stars; 2/3 security scanners passed (skills.sh audits).
What problem does it solve?
You are scoping a regulated device and do not know which clinical evidence tier, literature path, or investigation triggers apply to your MDR class and claims.
Who is it for?
Medtech founders, QA/regulatory contractors, and agent-assisted authors drafting CEP/CER outlines for EU MDR Class IIa–III or novel Class IIb claims.
Skip if: General-purpose indie apps with no device labeling, non-EU-only products without MDR exposure, or teams seeking substitute for notified-body or legal approval.
When should I use this skill?
User or project needs EU MDR clinical evaluation framing, class-based evidence minimums, literature versus investigation strategy, or PMCF planning for a medical device.
What do I get? / Deliverables
You get a structured clinical evidence pathway—hierarchy, class minimums, evaluation steps, and PMCF hooks—to feed regulatory documentation and scope decisions before full build.
- Evidence strategy outline mapped to device class and novelty
- Clinical evaluation and PMCF section bullets for regulatory documentation drafts
Recommended Skills
Journey fit
Regulatory evidence strategy and class-based minimums must be nailed down in Validate before you scope engineering spend on a CE-mark path. Scope subphase is where you define classification, evidence hierarchy, and whether investigations are required—not after code is frozen.
How it compares
Use this regulatory methodology skill instead of generic security checklists that do not map evidence types to MDR Annex XIV classes.
Common Questions / FAQ
Who is mdr-745-specialist for?
Builders and consultants working on EU MDR medical devices who need structured clinical evaluation and PMCF framing during validation and scoping.
When should I use mdr-745-specialist?
In Validate scope work when you classify the device, choose literature versus investigation strategy, or draft Annex XIV-aligned clinical evaluation and follow-up plans before major engineering.
Is mdr-745-specialist safe to install?
It is documentation-style guidance without built-in shell or network steps; still verify content against current MDR texts and review the Security Audits panel on this page.
SKILL.md
READMESKILL.md - Mdr 745 Specialist
# Clinical Evidence Requirements MDR Annex XIV clinical evaluation and post-market clinical follow-up guidance. --- ## Table of Contents - [Clinical Evidence Framework](#clinical-evidence-framework) - [Clinical Evaluation Process](#clinical-evaluation-process) - [Literature-Based Evidence](#literature-based-evidence) - [Clinical Investigation Requirements](#clinical-investigation-requirements) - [Post-Market Clinical Follow-up](#post-market-clinical-follow-up) --- ## Clinical Evidence Framework ### Evidence Hierarchy | Evidence Type | Strength | When to Use | |---------------|----------|-------------| | Randomized Controlled Trial | Highest | Novel Class III, high-risk claims | | Prospective cohort study | High | New technology, performance claims | | Retrospective analysis | Medium | Established technology, equivalence | | Literature review | Medium | Well-characterized, equivalent devices | | Expert opinion | Low | Supportive only, not primary | ### Evidence Requirements by Class | Class | Minimum Evidence | Clinical Investigation | |-------|------------------|------------------------| | I | Risk-benefit analysis | Not typically required | | IIa | Literature + post-market data | May be required for novel tech | | IIb | Systematic literature review | Often required for claims | | III | Comprehensive clinical data | Required unless equivalent | ### Clinical Evidence Pathway Determine evidence strategy: 1. Assess device classification and risk level 2. Evaluate claim significance (diagnostic, therapeutic) 3. Determine if equivalence can be demonstrated 4. Identify available literature and clinical data 5. Assess gaps requiring additional investigation 6. Develop PMCF plan for ongoing evidence 7. **Validation:** Evidence strategy approved by Notified Body --- ## Clinical Evaluation Process ### Clinical Evaluation Workflow Execute clinical evaluation per Annex XIV Part A: 1. Identify relevant safety and performance data 2. Define scope and search strategy 3. Conduct systematic literature search 4. Appraise and analyze clinical data 5. Assess benefit-risk profile 6. Document conclusions in Clinical Evaluation Report (CER) 7. Plan post-market clinical follow-up 8. **Validation:** CER reviewed by qualified clinical evaluator ### Clinical Evaluation Report Structure ``` CLINICAL EVALUATION REPORT (CER) ├── 1. Executive Summary │ ├── Device description and intended purpose │ ├── Conclusions on safety and performance │ └── Benefit-risk conclusion ├── 2. Scope of Clinical Evaluation │ ├── Device identification │ ├── Clinical claims to be evaluated │ └── Equivalence assessment (if applicable) ├── 3. Clinical Background │ ├── Disease/condition overview │ ├── Current treatment options │ └── State of the art ├── 4. Clinical Data Sources │ ├── Pre-clinical data (bench, animal) │ ├── Clinical investigation data │ ├── Literature search methodology │ └── Post-market surveillance data ├── 5. Data Appraisal │ ├── Study quality assessment │ ├── Relevance to subject device │ └── Data contribution to evaluation ├── 6. Data Analysis │ ├── Safety analysis │ ├── Performance analysis │ └── Benefit-risk determination ├── 7. Conclusions │ ├── Clinical evidence summary │ ├── Residual risks │ └── PMCF requirements └── 8. PMCF Plan Summary ├── Data gaps identified ├── PMCF activities planned └── Update schedule ``` ### Qualified Clinical Evaluator Requirements per Annex XIV: - Medical degree or equivalent healthcare qualification - 4+ years clinical experience in relevant field OR - Research background in relevant domain - Training in clinical evaluation methodology - Understanding of MDR requirements --- ## Literature-Based Evidence ### Literature Search Strategy Execute systematic literature review: 1. Define PICO question (Population, Intervention, Comparison, Outcome) 2. Develop search string with Boolean operators 3. Select databases (PubMed, Embase, Cochrane, etc.) 4. S