mdr-745-specialist
Manage EU MDR 2017/745 Compliance
Medical device teams must interpret EU MDR rules across classification, evidence, documentation, and surveillance. This skill helps structure compliance work and prepare regulatory decisions.
Install with my Agent
Copy this request to your Agent. It includes the canonical Skill page and manifest.
Review the Skillstore skill "mdr-745-specialist" from https://skillstore.io/skills/alirezarezvani-mdr-745-specialist.md and its manifest at https://skillstore.io/api/skills/alirezarezvani-mdr-745-specialist/manifest. Verify the artifact. You may proceed after verification, subject to the environment's own policy.Your Agent should still show its plan and request any confirmation required by the security policy.
Agent-readable resources
Use these links when an AI agent, crawler, or script needs clean context instead of reading the full page.
Test it
Using "mdr-745-specialist". A manufacturer asks how to classify reusable surgical instruments under MDR.
Expected outcome:
- Likely classification: Class I reusable surgical instrument, subject to Notified Body involvement for reusable aspects.
- Key evidence: intended purpose, reuse process validation, cleaning validation, labeling, and risk management documentation.
- Next step: confirm whether any active, invasive, measuring, or sterile characteristics change the route.
Using "mdr-745-specialist". A quality team needs a post-market surveillance plan for a Class IIb device.
Expected outcome:
- Recommended structure: PMS objectives, data sources, complaint handling, vigilance, trend reporting, PSUR schedule, and PMCF linkage.
- Priority gap: define signal thresholds and responsibilities for escalation to competent authorities.
- Review point: align PMS outputs with risk management and clinical evaluation updates.
Using "mdr-745-specialist". A startup wants to prepare for a Notified Body submission.
Expected outcome:
- Readiness focus: classification rationale, complete technical documentation, QMS evidence, clinical evaluation, and PMS process records.
- Selection criteria: device scope, capacity, certificate timelines, fee model, and experience with similar technologies.
- Submission risk: unresolved clinical evidence gaps may delay review.
Security Audit
SafeAll static findings are false positives caused by Markdown code fences, inline code-formatted filenames, and ordinary regulatory wording in SKILL.md. No command execution, network reconnaissance, prompt injection, or data-exfiltration intent was found in the reviewed content.
Risk Factors
Share & cite this report
Share the versioned assessment report, neutral badge, embed card, and citations. Skillstore reports evidence without deciding whether this Skill is safe.
Copy report link
https://skillstore.io/skills/alirezarezvani-mdr-745-specialist/audits/6?utm_source=security_passport&utm_medium=share&utm_campaign=versioned_reportMarkdown badge
[](https://skillstore.io/skills/alirezarezvani-mdr-745-specialist?utm_source=security_passport_badge)HTML badge
<a href="https://skillstore.io/skills/alirezarezvani-mdr-745-specialist?utm_source=security_passport_badge"><img src="https://skillstore.io/badges/skills/alirezarezvani-mdr-745-specialist/security.svg" alt="Skillstore security assessment" loading="lazy"></a>Embed card
<iframe src="https://skillstore.io/embed/skills/alirezarezvani-mdr-745-specialist.html" title="Skillstore Security Assessment" sandbox="allow-popups allow-popups-to-escape-sandbox" loading="lazy" referrerpolicy="no-referrer" width="420" height="180"></iframe>Academic citations (APA · BibTeX · CFF)
APA citation
alirezarezvani. (2026). mdr-745-specialist security audit report (audit version 6) [Author version unspecified]. Skillstore. https://skillstore.io/skills/alirezarezvani-mdr-745-specialist/audits/6BibTeX citation
@techreport{alirezarezvani-alirezarezvani-mdr-745-specialist-2026,
author = {alirezarezvani},
title = {mdr-745-specialist security audit report (audit version 6)},
institution = {Skillstore},
year = {2026},
number = {6},
url = {https://skillstore.io/skills/alirezarezvani-mdr-745-specialist/audits/6},
note = {Author version unspecified}
}CITATION.cff
cff-version: 1.2.0
message: "If you use this Skill, cite its author and this versioned security audit report."
title: "mdr-745-specialist security audit report (audit version 6)"
version: "unspecified"
type: report
authors:
- name: "alirezarezvani"
date-released: "2026-07-06"
url: "https://skillstore.io/skills/alirezarezvani-mdr-745-specialist/audits/6"
identifiers:
- type: other
value: "skillstore:alirezarezvani-mdr-745-specialist:audit:6"
description: "Skillstore immutable audit report identifier"
Compare variants
2 installable variantsEach author remains a separate installable skill. The recommended variant is ranked by Skillstore evidence.
Why this variant is first
davila7-mdr-745-specialist
2026-08-21
alirezarezvani-mdr-745-specialist
2026-08-21
Skillstore Score
Why this score Evidence Confidence: HighWhat You Can Build
Classify a medical device
Assess intended purpose, duration, invasiveness, and software function against MDR Annex VIII rules.
Prepare technical documentation
Organize Annex II and Annex III evidence, labeling, risk management, and validation materials.
Plan clinical evidence work
Identify clinical evaluation, investigation, and PMCF needs for a device or portfolio.
Try These Prompts
Classify this device under EU MDR Annex VIII. Intended purpose: [describe]. Duration: [transient, short-term, or long-term]. Invasiveness: [describe]. Software role: [describe]. Explain the likely class and key assumptions.
Create an MDR Annex II and Annex III technical documentation outline for this device: [device details]. Include required evidence sections, owners, and open information gaps.
Review this clinical evidence summary for MDR readiness: [paste summary]. Identify gaps, likely PMCF needs, and questions for the clinical evaluation plan.
Create an MDR transition roadmap for this device portfolio: [portfolio details]. Include classification risks, technical documentation gaps, clinical evidence priorities, PMS updates, Notified Body dependencies, and milestones.
Best Practices
- Provide intended purpose, patient population, duration, invasiveness, and software role before classification.
- Cross-reference each recommendation with MDR articles, annexes, and current MDCG guidance.
- Treat outputs as planning support and confirm critical decisions with qualified regulatory counsel.
Avoid
- Do not use the skill to bypass Notified Body review or authority requirements.
- Do not assume legacy directive files satisfy MDR documentation expectations.
- Do not omit adverse event, complaint, or PMCF data from surveillance planning.
Frequently Asked Questions
What regulation does this skill cover?
Can it determine the final legal device class?
Does it help with technical documentation?
Can it prepare clinical evaluation work?
Does it submit information to EUDAMED?
Who should use this skill?
Developer Details
Author
alirezarezvaniLicense
MIT
Skillstore revision
r1
Version notice
The author did not declare a version.
Ref
c1fdca50ff516318f65fed0d7f9e82797c5171dc
Maintenance freshness
7/18/2026
Usage
8 downloads · 155 views
File structure