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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).
This skill has not been reviewed by our automated audit pipeline yet.
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