Agent skill

Mdr 745 Specialist

by LeoYeAI in LeoYeAI/openclaw-master-skills

EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance.

MITAuto-check passedDevelopment

Install Mdr 745 Specialist

skills CLI
$ npx skills add LeoYeAI/openclaw-master-skills --skill mdr-745-specialist -a claude-code

Project install by default; add -g for ~/.claude/skills/.

GitHub CLI
$ gh skill install LeoYeAI/openclaw-master-skills mdr-745-specialist --agent claude-code

Project scope by default; add --scope user for a personal install. Needs GitHub CLI 2.90.0 or later (public preview).

Manual copy
$ git clone --depth 1 https://github.com/LeoYeAI/openclaw-master-skills.git skills-src && mkdir -p .claude/skills && cp -r skills-src/skills/mdr-745-specialist .claude/skills/mdr-745-specialist && rm -rf skills-src

Use ~/.claude/skills/ instead of .claude/skills for a personal install. The folder must contain SKILL.md.

Claude Code skills documentation · loads skills from .claude/skills/

Facts

Skill name
mdr-745-specialist
GitHub stars
2.2k
Token cost
~2.4k tokens
SKILL.md length
902 words
Files
6 (incl. scripts, references)
Skills in repo
1,235
Repo updated
First seen
Licence
MIT

At a glance

EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance.

  • Works in 8 steps: Identify device duration (transient,… → Determine invasiveness level… → Assess body system contact (CNS,… → …
  • Tasks that involve Technical documentation
  • SKILL.md covers Table of Contents, Device Classification Workflow, Technical Documentation and Clinical Evidence, plus 5 more sections
  • Runs Python scripts from its folder; calls python

What it does

Mdr 745 Specialist is an agent skill from LeoYeAI/openclaw-master-skills. EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, and EUDAMED integration.

Its SKILL.md is about 2.4k tokens, which your agent loads only when the skill is triggered. The skill folder holds 7 other files, including scripts and reference files (for example `_meta.json`, `references/clinical-evidence-requirements.md` and `references/mdr-classification-guide.md`).

It sits in Development, covering Technical documentation. The repository describes itself as: 🧠 Curated collection of 1209+ best OpenClaw skills — weekly updated by MyClaw.ai. The licence is MIT.

When your agent uses it

  • Tasks that involve Technical documentation

Example prompts

  • “/mdr-745-specialist”

Requirements

  • Python 3

Workflow steps

8 steps, taken from the first numbered list in SKILL.md.

  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

What it can do on your machine

Read from SKILL.md and the folder at commit e5199b5. It shows what the files ask for, not the result of running them.

  • Tool permissions

    Pre-approves nothing: there is no allowed-tools line, so your agent's usual permission prompts apply.

    From allowed-tools in the SKILL.md frontmatter.

  • Runs code

    Ships 1 file in scripts/ (Python), which the agent can run.

    Shell commands in SKILL.md call:

    • python

    From the folder's file list and the shell code blocks in SKILL.md.

  • Network

    No URLs in SKILL.md.

    From URLs in SKILL.md, links to its own repository left out.

  • Credentials

    Names no API keys, tokens, secrets or passwords.

    From names ending in _API_KEY, _TOKEN, _SECRET, _KEY or _PASSWORD in SKILL.md.

Context cost

Mdr 745 Specialist loads about 2.4k tokens when it runs, and up to ~9.6k if it reads all its reference files. Until then it costs about 73 tokens; SKILL.md has 902 words of instructions outside code blocks.

Always · name and description, kept in context so the agent knows when to use it
~73
When it runs · the whole SKILL.md, loaded when a task matches
~2.4k
With references · SKILL.md plus every file in references/, read only if the agent opens them
~9.6k

Estimates: characters ÷ 4, the usual rule of thumb; real counts depend on the model's tokenizer. Scripts and assets cost tokens only if the agent reads them.

Safety

Auto-check passed

The automated check found no risky patterns in SKILL.md.

Automated static check — not a guarantee. Review scripts before installing. It scans the text of SKILL.md for risky patterns (piping downloads into a shell, reading credential files, hidden Unicode, destructive commands); the scripts in this folder are not scanned.

SKILL.md

The full file from LeoYeAI/openclaw-master-skills at commit e5199b5, republished under its MIT licence (© LeoYeAI). 902 words, ~2,448 tokens.

Download SKILL.mdSave it as .claude/skills/mdr-745-specialist/SKILL.md (or your agent's skills folder). This skill also uses 5 other files; get the full folder from GitHub.
name
mdr-745-specialist
description
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, and EUDAMED integration.
triggers
MDR compliance, EU MDR, medical device classification, Annex VIII, technical documentation, clinical evaluation, PMCF, EUDAMED, UDI, notified body

MDR 2017/745 Specialist

EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence.


Table of Contents


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
FactorClass IClass IIaClass IIbClass III
DurationAnyShort-termLong-termLong-term
InvasivenessNon-invasiveBody orificeSurgicalImplantable
SystemAnyNon-criticalCritical organsCNS/cardiac
RiskLowestLow-mediumMedium-highHighest
Software Classification (MDCG 2019-11)
Information UseCondition SeverityClass
Informs decisionNon-seriousIIa
Informs decisionSeriousIIb
Drives/treatsCriticalIII
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. Complete GSPR compliance matrix
  5. Prepare benefit-risk analysis
  6. Compile verification and validation evidence
  7. Integrate risk management file (ISO 14971)
  8. Validation: Technical file reviewed for completeness
Technical File Structure
ANNEX II TECHNICAL DOCUMENTATION
├── Device description and UDI-DI
├── Label and instructions for use
├── Design and manufacturing info
├── GSPR compliance matrix
├── Benefit-risk analysis
├── Verification and validation
└── Clinical evaluation report
GSPR Compliance Checklist
RequirementEvidenceStatus
Safe design (GSPR 1-3)Risk management file☐
Chemical properties (GSPR 10.1)Biocompatibility report☐
Infection risk (GSPR 10.2)Sterilization validation☐
Software requirements (GSPR 17)IEC 62304 documentation☐
Labeling (GSPR 23)Label artwork, IFU☐
Conformity Assessment Routes
ClassRouteNB Involvement
IAnnex II self-declarationNone
Is/ImAnnex II + IX/XISterile/measuring aspects
IIaAnnex II + IX or XIProduct or QMS
IIbAnnex IX + X or X + XIType exam + production
IIIAnnex IX + XFull QMS + type exam

Clinical Evidence

Develop clinical evidence strategy per Annex XIV:

  1. Define clinical claims and endpoints
  2. Conduct systematic literature search
  3. Appraise clinical data quality
  4. Assess equivalence (technical, biological, clinical)
  5. Identify evidence gaps
  6. Determine if clinical investigation required
  7. Prepare Clinical Evaluation Report (CER)
  8. Validation: CER reviewed by qualified evaluator
Evidence Requirements by Class
ClassMinimum EvidenceInvestigation
IRisk-benefit analysisNot typically required
IIaLiterature + post-marketMay be required
IIbSystematic literature reviewOften required
IIIComprehensive clinical dataRequired (Article 61)
Clinical Evaluation Report Structure
CER CONTENTS
├── Executive summary
├── Device scope and intended purpose
├── Clinical background (state of the art)
├── Literature search methodology
├── Data appraisal and analysis
├── Safety and performance conclusions
├── Benefit-risk determination
└── PMCF plan summary
Qualified Evaluator Requirements
  • Medical degree or equivalent healthcare qualification
  • 4+ years clinical experience in relevant field
  • Training in clinical evaluation methodology
  • Understanding of MDR requirements

Post-Market Surveillance

Establish PMS system per Chapter VII:

  1. Develop PMS plan (Article 84)
  2. Define data collection methods
  3. Establish complaint handling procedures
  4. Create vigilance reporting process
  5. Plan Periodic Safety Update Reports (PSUR)
  6. Integrate with PMCF activities
  7. Define trend analysis and signal detection
  8. Validation: PMS system audited annually
PMS System Components
ComponentRequirementFrequency
PMS PlanArticle 84Maintain current
PSURClass IIa and higherPer class schedule
PMCF PlanAnnex XIV Part BUpdate with CER
PMCF ReportAnnex XIV Part BAnnual (Class III)
VigilanceArticles 87-92As events occur
Show full SKILL.md (342 more words)Show less
PSUR Schedule
ClassFrequency
Class IIIAnnual
Class IIb implantableAnnual
Class IIbEvery 2 years
Class IIaWhen necessary
Serious Incident Reporting
TimelineRequirement
2 daysSerious public health threat
10 daysDeath or serious deterioration
15 daysOther serious incidents

EUDAMED and UDI

Implement UDI system per Article 27:

  1. Obtain issuing entity code (GS1, HIBCC, ICCBBA)
  2. Assign UDI-DI to each device variant
  3. Assign UDI-PI (production identifier)
  4. Apply UDI carrier to labels (AIDC + HRI)
  5. Register actor in EUDAMED
  6. Register devices in EUDAMED
  7. Upload certificates when available
  8. Validation: UDI verified on sample labels
EUDAMED Modules
ModuleContentActor
ActorCompany registrationManufacturer, AR
UDI/DeviceDevice and variant dataManufacturer
CertificatesNB certificatesNotified Body
Clinical InvestigationStudy registrationSponsor
VigilanceIncident reportsManufacturer
Market SurveillanceAuthority actionsCompetent Authority
UDI Label Requirements

Required elements per Article 13:

  • UDI-DI (device identifier)
  • UDI-PI (production identifier) for Class II+
  • AIDC format (barcode/RFID)
  • HRI format (human-readable)
  • Manufacturer name and address
  • Lot/serial number
  • Expiration date (if applicable)

Reference Documentation

MDR Classification Guide

references/mdr-classification-guide.md contains:

  • Complete Annex VIII classification rules (Rules 1-22)
  • Software classification per MDCG 2019-11
  • Worked classification examples
  • Conformity assessment route selection
Clinical Evidence Requirements

references/clinical-evidence-requirements.md contains:

  • Clinical evidence framework and hierarchy
  • Literature search methodology
  • Clinical Evaluation Report structure
  • PMCF plan and evaluation report guidance
Technical Documentation Templates

references/technical-documentation-templates.md contains:

  • Annex II and III content requirements
  • Design History File structure
  • GSPR compliance matrix template
  • Declaration of Conformity template
  • Notified Body submission checklist

Tools

MDR Gap Analyzer
bash
# Quick gap analysis
python scripts/mdr_gap_analyzer.py --device "Device Name" --class IIa

# JSON output for integration
python scripts/mdr_gap_analyzer.py --device "Device Name" --class III --output json

# Interactive assessment
python scripts/mdr_gap_analyzer.py --interactive

Analyzes device against MDR requirements, identifies compliance gaps, generates prioritized recommendations.

Output includes:

  • Requirements checklist by category
  • Gap identification with priorities
  • Critical gap highlighting
  • Compliance roadmap recommendations

Notified Body Interface

Selection Criteria
FactorConsiderations
Designation scopeCovers your device type
CapacityTimeline for initial audit
Geographic reachMarkets you need to access
Technical expertiseExperience with your technology
Fee structureTransparency, predictability
Pre-Submission Checklist
  • Technical documentation complete
  • GSPR matrix fully addressed
  • Risk management file current
  • Clinical evaluation report complete
  • QMS (ISO 13485) certified
  • Labeling and IFU finalized
  • Validation: Internal gap assessment complete

© LeoYeAI, MIT. Rendered from Markdown: HTML in the file is shown as text, images as links, and headings moved down two levels. Raw file

Files

SKILL.md and 5 other files (scripts, references) in skills/mdr-745-specialist of LeoYeAI/openclaw-master-skills.

  • SKILL.md
  • _meta.json
  • references/clinical-evidence-requirements.md
  • references/mdr-classification-guide.md
  • references/technical-documentation-templates.md
  • scripts/mdr_gap_analyzer.py

Open the folder on GitHubat commit e5199b5

Compare with similar skills

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Categories

Questions about Mdr 745 Specialist

What does Mdr 745 Specialist do?

EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Mdr 745 Specialist is an agent skill from LeoYeAI/openclaw-master-skills. EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance.

When should I use Mdr 745 Specialist?

Mdr 745 Specialist fits situations like: tasks that involve Technical documentation.

How do I install Mdr 745 Specialist in Claude Code?

Run `npx skills add LeoYeAI/openclaw-master-skills --skill mdr-745-specialist -a claude-code`. Or copy the skill folder (skills/mdr-745-specialist in LeoYeAI/openclaw-master-skills) into .claude/skills/mdr-745-specialist in your project. Claude Code loads it when a task matches its description.

How do I install Mdr 745 Specialist in Codex?

Run `npx skills add LeoYeAI/openclaw-master-skills --skill mdr-745-specialist -a codex`. Or copy the skill folder (skills/mdr-745-specialist in LeoYeAI/openclaw-master-skills) into .agents/skills/mdr-745-specialist in your project. Codex loads it when a task matches its description.

Can I use Mdr 745 Specialist in Cursor, Gemini CLI or GitHub Copilot?

Cursor, Gemini CLI, GitHub Copilot and OpenCode also load SKILL.md folders. With the skills CLI, run `npx skills add LeoYeAI/openclaw-master-skills --skill mdr-745-specialist -a cursor` (or -a gemini-cli, github-copilot or opencode for the others). To copy it by hand, put the folder in .cursor/skills/mdr-745-specialist, .gemini/skills/mdr-745-specialist, .github/skills/mdr-745-specialist and .opencode/skills/mdr-745-specialist in your project.

What does Mdr 745 Specialist need to run?

Going by SKILL.md and its folder, Mdr 745 Specialist needs Python for the scripts in its folder and the command-line tools its instructions call (python). Our summary lists: Python 3.

Does Mdr 745 Specialist access the network?

SKILL.md contains no URLs. Any network use would come from the scripts or tools the agent runs. This is read from the text; nothing was executed.

Is Mdr 745 Specialist safe to install?

Our automated static check of SKILL.md found no risky patterns, such as piping downloads into a shell, reading credential files or hidden Unicode. It is not a guarantee. The check reads SKILL.md only: the scripts in the folder are not scanned, so read them before running anything.

What licence does Mdr 745 Specialist use?

Mdr 745 Specialist is published under the MIT licence (the repository's licence). It allows redistribution, so the full SKILL.md is shown on this page.

How many tokens does Mdr 745 Specialist use?

About 2.4k tokens (SKILL.md is roughly 9.8k characters). Agents keep only the skill's name and description in context until a task matches; then they load SKILL.md in full. Its references folder adds about 7.2k tokens, read only when the agent opens those files.

What are the alternatives to Mdr 745 Specialist?

Skills that share tags, products or a category with Mdr 745 Specialist: Diagram Design (cathrynlavery/diagram-design, 49k stars), Simple English (moeru-ai/airi, 50k stars), Doc Sync (JetBrains/ideavim, 10k stars) and Mailspring App Screenshots (Foundry376/Mailspring, 18k stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.

Who maintains Mdr 745 Specialist?

LeoYeAI (a GitHub user) maintains it in LeoYeAI/openclaw-master-skills, which has 2,161 GitHub stars. The repository holds 1,235 skills in this directory. The repository was last updated on July 20, 2026.

Source: LeoYeAI/openclaw-master-skills on GitHub. Facts on this page come from the repository at the commit we read; the author's words are quoted as theirs.