mdr-745-specialist

---
name: mdr-745-specialist
description: Use when classifying a medical device under EU MDR, building or gap-checking a technical file, planning clinical evaluation or PMS/PSUR cadence, or preparing for Notified Body review.
category: Regulatory & Quality
version: 1.0.0
tools: []
---

# MDR 2017/745 Specialist

EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence.

## Device Classification Workflow

Classify the device under MDR Annex VIII:

1. Identify device duration (transient, short-term, long-term)
2. Determine invasiveness level (non-invasive, body orifice, surgical)
3. Assess body system contact (CNS, cardiac, other)
4. Check if active device (energy dependent)
5. Apply classification rules 1-22
6. For software, apply the MDCG 2019-11 algorithm
7. Document the classification rationale
8. Validate: 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

- **Absorbable surgical suture** — Rule 8 (implantable, long-term), duration >30 days (absorbed) → **Class IIb**
- **AI diagnostic software** — Rule 11 + MDCG 2019-11, diagnoses a serious condition → **Class IIb**
- **Cardiac pacemaker** — Rule 8 (implantable), central circulatory system → **Class III**

## Technical Documentation

Prepare the technical file per Annex II and III:

1. Create the device description (variants, accessories, intended purpose)
2. Develop labeling (Article 13 requirements, IFU)
3. Document design and manufacturing process
4. Complete the GSPR compliance matrix
5. Prepare a benefit-risk analysis
6. Compile verification and validation evidence
7. Integrate the risk management file (ISO 14971)
8. Validate: technical file reviewed for completeness

### GSPR Compliance Checklist

| Requirement | Evidence |
|-------------|----------|
| 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, or Annex X + XI | QMS + tech doc assessment, or type exam + production |
| III | Annex IX, or Annex X + XI | Full QMS + product dossier, or type exam + production |

## Clinical Evidence

Develop the clinical evidence strategy per Annex XIV:

1. Define clinical claims and endpoints
2. Conduct a systematic literature search
3. Appraise clinical data quality
4. Assess equivalence (technical, biological, clinical)
5. Identify evidence gaps
6. Determine if clinical investigation is required
7. Prepare the Clinical Evaluation Report (CER)
8. Validate: CER reviewed by a 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) |

A CER covers executive summary, device scope, clinical background (state of the art), literature search methodology, data appraisal, safety/performance conclusions, benefit-risk determination, and a PMCF plan summary. A qualified evaluator needs a medical degree or equivalent, 4+ years of clinical experience in the relevant field, and training in clinical evaluation methodology.

## Post-Market Surveillance

Establish the PMS system per Chapter VII:

1. Develop the PMS plan (Article 84)
2. Define data collection methods
3. Establish complaint handling procedures
4. Create the vigilance reporting process
5. Plan Periodic Safety Update Reports (PSUR)
6. Integrate with PMCF activities
7. Define trend analysis and signal detection
8. Validate: PMS system audited annually

PMS components: PMS Plan (Article 84), PSUR (Article 86 — Class IIa and higher, per schedule below), PMCF Plan/Report (Annex XIV Part B, annual for Class III), vigilance reporting (Articles 87-92, as events occur).

### PSUR Schedule (Art. 86(1))

| Class | Frequency |
|-------|-----------|
| Class III | Updated at least annually |
| Class IIb (all, incl. implantable) | Updated at least annually |
| Class IIa | When necessary, at least every 2 years |
| Class I | No PSUR — PMS report instead (Art. 85) |

### 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 the UDI system per Article 27:

1. Obtain an issuing entity code (GS1, HIBCC, ICCBBA)
2. Assign UDI-DI to each device variant
3. Assign UDI-PI (production identifier)
4. Apply UDI carrier to labels (AIDC + HRI)
5. Register actor in EUDAMED
6. Register devices in EUDAMED
7. Upload certificates when available
8. Validate: UDI verified on sample labels

EUDAMED modules: Actor (registration, by manufacturer/AR), UDI/Device (device data, manufacturer), Certificates (NB certificates), Clinical Investigation (study registration, sponsor), Vigilance (incident reports, manufacturer), Market Surveillance (authority actions).

Required UDI label elements (Article 13): UDI-DI, UDI-PI (Class II+), AIDC (barcode/RFID), HRI (human-readable), manufacturer name/address, lot/serial number, expiration date where applicable.

## Notified Body Interface

Selection criteria: designation scope (covers the device type), capacity (timeline for initial audit), geographic reach (markets needed), technical expertise (experience with the technology), and fee structure (transparency, predictability).

Pre-submission checklist: technical documentation complete, GSPR matrix fully addressed, risk management file current, clinical evaluation report complete, QMS (ISO 13485) certified, labeling and IFU finalized. Validate with an internal gap assessment before submission.