MDR 745 Specialist
This skill provides guidance on EU MDR 2017/745 compliance for medical devices.
Install
npx promptshop add mdr-745-specialistDetails
What This Skill Does
- This skill provides guidance on EU MDR 2017/745 compliance for medical devices.
- It covers device classification, technical documentation, clinical evidence, and post-market surveillance.
- It's intended for regulatory affairs specialists and product managers in the medical device industry.
When to Use
- Classify medical devices under MDR Annex VIII.
- Create technical documentation.
- Gather clinical evidence.
- Manage post-market surveillance.
- Understand EUDAMED and UDI requirements.
- Apply software classification rules.
Key Features
- Device classification workflow.
- Classification matrix by risk.
- Software classification algorithm (MDCG 2019-11).
- Examples of device classifications.
- Guidance on technical documentation requirements.
- Information on post-market surveillance obligations.
Manual Installation
Table of Contents
Device Classification Workflow
Technical Documentation Clinical Evidence Post-Market Surveillance EUDAMED and UDI Reference Documentation Tools
Device Classification Workflow
Classify device under MDR Annex VIII:
Identify device duration (transient, short-term, long-term) Determine invasiveness level (non-invasive, body orifice, surgical) Assess body system contact (CNS, cardiac, other) Check if active device (energy dependent) Apply classification rules 1-22 For software, apply MDCG 2019-11 algorithm Document classification rationale Validation: Classification confirmed with Notified Body
Classification Matrix
| Factor | Class I | Class IIa | Class IIb | Class III |
|---|---|---|---|---|
| Duration | Any | Short-term | Long-term | Long-term |
| Invasiveness | Non-invasive | Body orifice | Surgical | Implantable |
| System | Any | Non-critical | Critical organs | CNS/cardiac |
| Risk | Lowest | Low-medium | Medium-high | Highest |
Software Classification (MDCG 2019-11)
| Information Use | Condition Severity | Class |
|---|---|---|
| Informs decision | Non-serious | IIa |
| Informs decision | Serious | IIb |
| Drives/treats | Critical | III |
Classification Examples
Example 1: Absorbable Surgical Suture Rule 8 (implantable, long-term) Duration: > 30 days (absorbed) Contact: General tissue Classification: Class IIb
Example 2: AI Diagnostic Software Rule 11 + MDCG 2019-11 Function: Diagnoses serious condition Classification: Class IIb
Example 3: Cardiac Pacemaker Rule 8 (implantable) Contact: Central circulatory system Classification: Class III
Technical Documentation
Prepare technical file per Annex II and III:
Create device description (variants, accessories, intended purpose) Develop labeling (Article 13 requirements, IFU) Document design and manufacturing process Complete GSPR compliance matrix Prepare benefit-risk analysis Compile verification and validation evidence Integrate risk management file (ISO 14971) 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
GSPR Compliance Checklist
| Requirement | Evidence | Status |
|---|---|---|
| Safe design (GSPR 1-3) | Risk management file | ☐ |
| Chemical properties (GSPR 10.1) | Biocompatibility report | ☐ |
| Infection risk (GSPR 10.2) | Sterilization validation | ☐ |
| Software requirements (GSPR 17) | IEC 62304 documentation | ☐ |
| Labeling (GSPR 23) | Label artwork, IFU | ☐ |
Conformity Assessment Routes
| Class | Route | NB Involvement |
|---|---|---|
| I | Annex II self-declaration | None |
| Is/Im | Annex II + IX/XI | Sterile/measuring aspects |
| IIa | Annex II + IX or XI | Product or QMS |
| IIb | Annex IX + X or X + XI | Type exam + production |
| III | Annex IX + X | Full QMS + type exam |
Clinical Evidence
Develop clinical evidence strategy per Annex XIV:
Assess equivalence (technical, biological, clinical) Identify evidence gaps Determine if clinical investigation required Prepare Clinical Evaluation Report (CER) Validation: CER reviewed by qualified evaluator
Evidence Requirements by Class
| Class | Minimum Evidence | Investigation |
|---|---|---|
| I | Risk-benefit analysis | Not typically required |
| IIa | Literature + post-market | May be required |
| IIb | Systematic literature review | Often required |
| III | Comprehensive clinical data | Required (Article 61) |
Clinical Evaluation Report Structure
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) 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) Software classification per MDCG 2019-11 Worked classification examples Conformity assessment route selection
Clinical Evidence Requirements
references/clinical-evidence