Mdr 745 Specialist

What it does

When your agent uses it

• Classifying a medical device under MDR
• Gap-checking a technical file
• Planning clinical evaluation
• PMS/PSUR cadence

Example prompts

• “what class is my device under MDR”
• “review my PSUR schedule”
• “/mdr-745-specialist”

Requirements

• Python 3

Workflow steps

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

1. 1Identify device duration (transient, short-term, long-term)
2. 2Determine invasiveness level (non-invasive, body orifice, surgical)
3. 3Assess body system contact (CNS, cardiac, other)
4. 4Check if active device (energy dependent)
5. 5Apply classification rules 1-22
6. 6For software, apply MDCG 2019-11 algorithm
7. 7Document classification rationale
8. 8Validation: Classification confirmed with Notified Body

What it can do on your machine

Read from SKILL.md and the folder at commit 19392f7. 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 2.6k tokens when it runs, and up to ~9.8k if it reads all its reference files. Until then it costs about 142 tokens; SKILL.md has 938 words of instructions outside code blocks.

Always · name and description, kept in context so the agent knows when to use it

~142

When it runs · the whole SKILL.md, loaded when a task matches

~2.6k

With references · SKILL.md plus every file in references/, read only if the agent opens them

~9.8k

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

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 alirezarezvani/claude-skills at commit 19392f7, republished under its MIT licence (© alirezarezvani). 938 words, ~2,576 tokens.

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, Art. 86 PSUR schedules, and EUDAMED integration. Use when classifying a medical device under MDR, building or gap-checking a technical file, planning clinical evaluation or PMS/PSUR cadence, or preparing for notified body review (e.g., 'what class is my device under MDR', 'review my PSUR schedule').

triggers

MDR compliance, EU MDR, medical device classification, Annex VIII, technical documentation, clinical evaluation, PMCF, EUDAMED, UDI, notified body

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

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

# 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

© alirezarezvani, 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 4 other files (scripts, references) in ra-qm-team/skills/mdr-745-specialist of alirezarezvani/claude-skills.

• SKILL.md
• 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 19392f7