Manage — EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification
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Manage — EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification
Validation: Technical file reviewed for completeness
Technical File Structure
ANNEX II TECHNICAL DOCUMENTATION
├── Device description and UDI-DI
├── Label and instructions for use
├── Design and manufacturing info
├── GSPR compliance matrix
├── Benefit-risk analysis
├── Verification and validation
└── Clinical evaluation report
CER CONTENTS
├── Executive summary
├── Device scope and intended purpose
├── Clinical background (state of the art)
├── Literature search methodology
├── Data appraisal and analysis
├── Safety and performance conclusions
├── Benefit-risk determination
└── PMCF plan summary
Qualified Evaluator Requirements
Medical degree or equivalent healthcare qualification
4+ years clinical experience in relevant field
Training in clinical evaluation methodology
Understanding of MDR requirements
Post-Market Surveillance
Establish PMS system per Chapter VII:
Develop PMS plan (Article 84)
Define data collection methods
Establish complaint handling procedures
Create vigilance reporting process
Plan Periodic Safety Update Reports (PSUR)
Integrate with PMCF activities
Define trend analysis and signal detection
Validation: PMS system audited annually
PMS System Components
Component
Requirement
Frequency
PMS Plan
Article 84
Maintain current
PSUR
Class IIa and higher
Per class schedule
PMCF Plan
Annex XIV Part B
Update with CER
PMCF Report
Annex XIV Part B
Annual (Class III)
Vigilance
Articles 87-92
As events occur
PSUR Schedule
Class
Frequency
Class III
Annual
Class IIb implantable
Annual
Class IIb
Every 2 years
Class IIa
When necessary
Serious Incident Reporting
Timeline
Requirement
2 days
Serious public health threat
10 days
Death or serious deterioration
15 days
Other serious incidents
EUDAMED and UDI
Implement UDI system per Article 27:
Obtain issuing entity code (GS1, HIBCC, ICCBBA)
Assign UDI-DI to each device variant
Assign UDI-PI (production identifier)
Apply UDI carrier to labels (AIDC + HRI)
Register actor in EUDAMED
Register devices in EUDAMED
Upload certificates when available
Validation: UDI verified on sample labels
EUDAMED Modules
Module
Content
Actor
Actor
Company registration
Manufacturer, AR
UDI/Device
Device and variant data
Manufacturer
Certificates
NB certificates
Notified Body
Clinical Investigation
Study registration
Sponsor
Vigilance
Incident reports
Manufacturer
Market Surveillance
Authority actions
Competent Authority
UDI Label Requirements
Required elements per Article 13:
UDI-DI (device identifier)
UDI-PI (production identifier) for Class II+
AIDC format (barcode/RFID)
HRI format (human-readable)
Manufacturer name and address
Lot/serial number
Expiration date (if applicable)
Reference Documentation
MDR Classification Guide
references/mdr-classification-guide.md contains:
Complete Annex VIII classification rules (Rules 1-22)
Manage — EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification
When to Use
Use this skill when the task requires mdr 745 specialist capabilities.
What If Fails
If this skill fails to produce the expected output: (1) verify input completeness, (2) retry with more specific context, (3) fall back to the parent workflow without this skill.
