mdr-745-specialist

Annex II and III technical documentation under EU MDR 2017/745 must systematically describe device design, risk assessment, manufacturing controls, and clinical evidence. This Skill provides structured templates and routing logic to organize conformity assessment files, classify documentation requirements by device risk class, and align submissions with Notified Body expectations.

EU MDR requires clinical evidence proportionate to device risk and predicate data availability, documented in Annex XIV clinical evaluation reports. This Skill maps clinical evidence strategies, PMCF (post-market clinical follow-up) planning, and evidence gaps specific to your device classification to meet regulatory timelines and Notified Body audit requirements.

UDI management under EU MDR 2017/745 requires EUDAMED database submission, device identification codes, and traceability workflows. This Skill guides UDI strategy, EUDAMED integration steps, and unique identifier lifecycle management to ensure compliant post-market surveillance and regulatory reporting.

MDR conformity assessment evaluates device classification, technical file completeness, clinical evidence adequacy, risk management, and Notified Body readiness. This Skill provides a structured decision framework to identify compliance gaps, prioritize remediation, and route assessments through the appropriate conformity pathway for your device's risk class.

Notified Body involvement depends on device classification under MDR 2017/745: Class I devices typically self-certify; Class IIa, IIb, and III require third-party conformity assessment. This Skill clarifies when Notified Body engagement is mandatory, audit readiness steps, and documentation requirements for each classification pathway.

Post-market surveillance under EU MDR 2017/745 requires ongoing safety monitoring, adverse event reporting, and periodic safety update (PSUR) submissions to EUDAMED. This Skill structures PMCF planning, post-market surveillance strategies, and regulatory reporting workflows to maintain device compliance and track real-world performance data.