mdr-745-specialist

EU MDR classification is determined by applying Annex VIII rules and MDCG guidance. This Skill automates classification rationale generation, including specific software classification per MDCG 2019-11, to ensure your device is categorized correctly for regulatory submissions.

EUDAMED integration requires structured device registry data, UDI implementation, and certificate alignment. This Skill provides planning for EUDAMED integration and UDI readiness to ensure your medical device meets the regulatory database submission requirements.

A CER and PMCF plan are generated by aligning clinical evidence with Annex XIV requirements and risk management. This Skill automates CER generation and PMCF planning to maintain continuous post-market surveillance and regulatory compliance.

Yes, this Skill is specifically applied to medical devices undergoing MDR transition and post-market surveillance. It provides end-to-end guidance for updating Annex II/III technical files and aligning PMS activities for regulatory compliance.

Annex II and III technical documentation files are structured by orchestrating GSPR matrices, risk management files, and clinical evidence. This Skill automates documentation orchestration to ensure your regulatory submission files meet EU MDR standards.