mdr-745-specialist

What problem does it solve?

This Skill provides expert guidance and structured workflows for navigating the complex requirements of the EU Medical Device Regulation (MDR) 2017/745, ensuring compliance for medical devices.

Core Features & Use Cases

• Device Classification: Classify medical devices according to Annex VIII rules.
• Technical Documentation: Assist in preparing technical files as per Annex II and III.
• Clinical Evidence: Guide the development of clinical evaluation reports (CERs).
• Post-Market Surveillance: Outline PMS and PSUR requirements.
• EUDAMED & UDI: Explain EUDAMED registration and UDI implementation.
• Use Case: A startup developing a new class IIa medical device can use this Skill to understand the classification rules, the required technical documentation structure, and the necessary clinical evidence to prepare for submission.

Quick Start

Use the mdr-745-specialist skill to classify a new medical device based on its intended use and characteristics.