from skillshub46
Assist with EU MDR 2017/745 compliance: device classification (Annex VIII), Annex II/III technical documentation, clinical evaluation (Annex XIV), PMS, and EUDA
Practical guidance and checklists for EU Medical Device Regulation (MDR 2017/745) compliance. Covers device classification (Annex VIII), preparing Annex II/III technical documentation, clinical evaluation (Annex XIV), post-market surveillance and EUDAMED/UDI registration. Includes worked examples, templates, and an MDR gap analyzer tool to generate prioritized remediation steps.
Use this skill when classifying a medical device, preparing technical files for conformity assessment, drafting a Clinical Evaluation Report (CER), planning PMCF/PMS activities, or preparing EUDAMED/UDI registrations. Helpful during pre-submission reviews and Notified Body selection.
Best used with agent setups that can read long-form guidance and produce documents (e.g., Claude, Gemini, Copilot-like assistants).
MDR 2017/745 compliance specialist skill providing EU medical device regulation reference material. Contains detailed classification workflows, technical documentation checklists, clinical evidence guidance, PMS procedures, and EUDAMED/UDI requirements. No bundled scripts — the referenced mdr_gap_analyzer.py and reference markdown files are not included, making this a read-only knowledge skill rather than a functional tool.
Clean skill with no security concerns — no scripts, no network calls, no credentials. Architecture incomplete: references scripts/ and references/ directories that aren't included. Useful as a regulatory reference guide but limited by missing tooling.
