med-device-eu SKILL.md skillA
med-device-eu from jgsystemsconsulting/jgs-se-knowledge-packs is an agent skill: a SKILL.md folder an AI agent loads when a task calls for it.
mdr add jgsystemsconsulting/jgs-se-knowledge-packs/med-device-eu@git:20261013.d45cfd2Pins git:20261013.d45cfd2 in mdr.lock. Pin the fingerprint instead.
- Audit grade
- A, 17 of 17 checks passed
- Kind
- SKILL.md skill
- Repository
- jgsystemsconsulting/jgs-se-knowledge-packs
- Path
packs/med-device-eu/SKILL.md- Versions recorded
- 1
- Latest version
- git:20261013.d45cfd2, committed Oct 13, 2026
- Size
- 10,134 bytes
- Repository stars
- 71
- License
- a license file GitHub does not identify
Reconstructed reference notes on EU and UK medical-device software, built from six sources captured 2026-10-13: MDCG 2019-11 rev.1 (June 2025), MDCG 2020-6 (April 2020), MDCG 2020-13 (July 2020), MDCG 2020-7 (April 2020), MDCG 2020-8 (April 2020), and the MHRA software-applications guidance (2023-07-01) with its stand-alone software PDF. Use for SaMD qualification and classification, legacy-device clinical evidence, the clinical evaluation assessment report, the PMCF plan, and the PMCF…
Collected from public GitHub. Every version is saved exactly as it was and never changes. Install it at an exact version with the mdr tool, and every file is checked before it reaches your agent. The main file is checked against the SHA-256 fingerprint recorded here, and the others against the fingerprints GitHub keeps for its source commit. The automatic checks below grade the latest version, and the same checks always give the same file the same grade.
What the file says
<!-- argument-hint: [device software question, qualification, classification, clinical evidence, PMCF, chapter number] --> # EU and UK Device Software Guidance (MDCG and MHRA) **Sources**: MDCG 2019-11 rev.1 (June 2025), MDCG 2020-6 (April 2020), MDCG 2020-13 (July 2020), MDCG 2020-7 (April 2020), MDCG 2020-8 (April 2020), and MHRA Medical devices: software applications (2023-07-01) with its stand-alone software guidance | **Licence**: per-document, see LICENSE | **Chapters**: 8 ## When to use **Prerequisites:** none: plain Markdown; no MCP server, API key, or licence tier needed at runtime. Use this pack for questions about software in and around medical devices on the EU and UK side: whether an app or stand-alone package qualifies as a device or an IVD and which risk class applies, what clinical evidence a legacy device needs under the MDR, how a notified body documents its assessment of a clinical evaluation, and what a post-market clinical follow-up plan commits to and how the evaluation report closes it. Both readings are taught: the MDCG guidance route for the EU and the MHRA guidance route for Great Britain. ## How to Use This Skill …
Read the whole file at its exact version.
How to install
mdr add jgsystemsconsulting/jgs-se-knowledge-packs/med-device-eu@sha256:cf016ccb4080b5edThe line at the top of this page pins the label git:20261013.d45cfd2, which is what most people want. This one pins the sha256 fingerprint of the contents instead, so it survives a label being moved. Either way the exact version is written to mdr.lock, and mdr install downloads and checks those contents again, so it installs them exactly or stops with an error.
[](https://markdownregistry.com/a/art_td6hddbgamiuy3jr)
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Versions
The registry has recorded 1 version of this file, committed on Oct 13, 2026.
Audit of the latest version
- pass: Frontmatter block present
- pass: Frontmatter declares a name
- pass: Frontmatter declares a description
- pass: Size between 200 bytes and 200 KB (10134 bytes)
- pass: No zero-width or bidi control characters
- pass: No instruction hidden inside an HTML comment
- pass: No link to an exfiltration or paste host
- pass: No credential-shaped string
- pass: No instruction to send local credentials anywhere
- pass: No text hidden with inline styles
- pass: No prompt-injection phrasing
- pass: No curl or wget piped into a shell
- pass: No recursive delete of root, home or parent
- pass: No instruction to read or print local credentials
- pass: No base64 blob over 200 characters
- pass: No link to a raw IP address
- pass: No script tag
Source
jgsystemsconsulting/jgs-se-knowledge-packs · 71 stars · license a license file GitHub does not identify · pushed 2026-11-04 · branch main
API
GET https://markdownregistry.com/api/v1/artifacts/art_td6hddbgamiuy3jr GET https://markdownregistry.com/api/v1/resolve?ref=jgsystemsconsulting/jgs-se-knowledge-packs/med-device-eu GET https://markdownregistry.com/api/v1/blob/cf016ccb4080b5edac076a23e2b4398f839513ea7aea7eb193de65bcb796142e
Your AI assistant does the legwork. You hear about the deals worth your word. Hand yours the standing instructions at modelranch.com and it joins the network that reads files like this one.
Guides: the SKILL.md format and its required fields · what to check before you install a skill · how to pin a skill to an exact version · where to find agent skills · keeping a team on the same skills · which agent file does what.