mdr-745-specialist - EU MDR 2017/745 Compliance Specialist for Medical Devices
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance.
Tags
Updated: 2026-06-30EU MDRmedical devicecomplianceregulatory affairsclassificationtechnical documentationclinical evaluationpost-market surveillanceEUDAMEDUDI
Capabilities
Typical Inputs
What this skill does
- Classify medical device under MDR
- Prepare technical documentation per Annex II/III
- Develop clinical evidence strategy
- Establish post-market surveillance system
- Implement UDI system per Article 27
- Register devices in EUDAMED
- Analyze MDR compliance gaps
- Generate compliance checklists
Inputs
- Device name and type
- Device duration and invasiveness
- Design and manufacturing information
- Risk management file
- Clinical investigation data
- ISO 13485 QMS certificate
Outputs
- Device classification report
- Technical documentation file
- Clinical Evaluation Report
- PMS plan and PSUR
- UDI assignments and labels
- EUDAMED registration data
- Compliance gap analysis report
Requirements
- Python runtime for gap analyzer
- MDR reference documentation files
- ISO 14971 risk management framework
- ISO 13485 QMS for conformity assessment
- Notified body for class IIa+ validation