mdr-745-specialist
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.
85
70%
Does it follow best practices?
Impact
96%
0.98xAverage score across 6 eval scenarios
Passed
No known issues
Optimize this skill with Tessl
npx tessl skill review --optimize ./ra-qm-team/mdr-745-specialist/SKILL.mdQuality
Discovery
82%Based on the skill's description, can an agent find and select it at the right time? Clear, specific descriptions lead to better discovery.
This is a strong, domain-specific description with excellent specificity and trigger term coverage for regulatory professionals. Its main weakness is the absence of an explicit 'Use when...' clause, which would help Claude know precisely when to select this skill. The regulatory terminology and annex references make it highly distinctive.
Suggestions
Add an explicit 'Use when...' clause, e.g., 'Use when the user asks about EU MDR compliance, medical device classification rules, CE marking requirements, technical file preparation, clinical evaluation reports, or post-market surveillance obligations.'
| Dimension | Reasoning | Score |
|---|---|---|
Specificity | Lists multiple specific concrete actions and domains: medical device classification, technical documentation, clinical evidence, post-market surveillance, and further specifies Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, and EUDAMED integration. | 3 / 3 |
Completeness | The description clearly answers 'what does this do' with specific regulatory areas and annexes, but lacks an explicit 'Use when...' clause or equivalent trigger guidance. The 'when' is only implied by the domain specificity, which per the rubric caps completeness at 2. | 2 / 3 |
Trigger Term Quality | Includes strong natural keywords users in this domain would use: 'EU MDR', '2017/745', 'medical device classification', 'technical documentation', 'clinical evidence', 'post-market surveillance', 'Annex VIII', 'Annex II/III', 'Annex XIV', 'EUDAMED'. These are the exact terms regulatory professionals would search for. | 3 / 3 |
Distinctiveness Conflict Risk | Highly distinctive with a very clear niche — EU MDR 2017/745 is a specific regulation, and the description references specific annexes and EUDAMED. This is extremely unlikely to conflict with other skills. | 3 / 3 |
Total | 11 / 12 Passed |
Implementation
57%Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.
This is a well-organized regulatory reference skill with good progressive disclosure and clear section structure. Its main weaknesses are that workflows lack concrete feedback loops and error recovery guidance, and much of the content is informational reference material (tables, checklists) rather than actionable instructions that add beyond what Claude already knows about EU MDR. The skill would benefit from more specific validation criteria and concrete examples of how to execute key steps.
Suggestions
Add concrete feedback loops to workflows: specify what to check at each validation step, what common failures look like, and how to recover (e.g., 'If classification is ambiguous between IIa and IIb, apply the higher class per MDR Article 51(7)').
Make key steps more actionable with specific methodology — e.g., for 'Conduct systematic literature search,' specify databases (PubMed, Embase), search string construction patterns, and inclusion/exclusion criteria templates.
Trim content Claude already knows (general descriptions of what modules contain, basic regulatory concepts) and focus tokens on non-obvious decision logic, edge cases, and common pitfalls specific to MDR compliance.
| Dimension | Reasoning | Score |
|---|---|---|
Conciseness | The content is reasonably structured but includes some information Claude would already know (e.g., what EUDAMED modules contain, basic definitions). The tables are useful reference material but some sections like 'Qualified Evaluator Requirements' and general descriptions add bulk without unique instructional value. Overall moderately efficient but could be tightened. | 2 / 3 |
Actionability | The skill provides structured workflows with numbered steps and useful reference tables, but most guidance remains at a procedural/checklist level rather than providing concrete, executable artifacts. The tool command examples are specific, but the core regulatory workflows describe what to do without showing exactly how (e.g., 'Conduct systematic literature search' lacks concrete methodology). Classification examples are a strength but are still high-level. | 2 / 3 |
Workflow Clarity | Each major section has numbered steps with a validation checkpoint at the end, which is good. However, the validation steps are generic ('Classification confirmed with Notified Body', 'Technical file reviewed for completeness') without specifying how to validate or what constitutes a pass/fail. There are no feedback loops for error recovery — if validation fails, there's no guidance on what to fix or how to iterate. | 2 / 3 |
Progressive Disclosure | The skill has a clear table of contents, well-organized sections, and appropriately references external files (references/mdr-classification-guide.md, references/clinical-evidence-requirements.md, references/technical-documentation-templates.md) for detailed content. References are one level deep and clearly signaled with descriptions of what each contains. | 3 / 3 |
Total | 9 / 12 Passed |
Validation
90%Checks the skill against the spec for correct structure and formatting. All validation checks must pass before discovery and implementation can be scored.
Validation — 10 / 11 Passed
Validation for skill structure
| Criteria | Description | Result |
|---|---|---|
frontmatter_unknown_keys | Unknown frontmatter key(s) found; consider removing or moving to metadata | Warning |
Total | 10 / 11 Passed | |
- Repository
- alirezarezvani/claude-skills
- Commit
f567c61
- Reviewed
Table of Contents
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