MDR 2017/745 Specialist

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

Table of Contents

• [Device Classification Workflow](#device-classification-workflow)

• [Technical Documentation](#technical-documentation)

• [Clinical Evidence](#clinical-evidence)

• [Post-Market Surveillance](#post-market-surveillance)

• [EUDAMED and UDI](#eudamed-and-udi)

• [Reference Documentation](#reference-documentation)

• [Tools](#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:

• Define clinical claims and endpoints

• Conduct systematic literature search

• Appraise clinical data quality

• 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)

• 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)

• Software classification per MDCG 2019-11

• Worked classification examples

• Conformity assessment route selection

Clinical Evidence Requirements

references/clinical-evidence-requirements.md contains:

• Clinical evidence framework and hierarchy

• Literature search methodology

• Clinical Evaluation Report structure

• PMCF plan and evaluation report guidance

Technical Documentation Templates

references/technical-documentation-templates.md contains:

• Annex II and III content requirements

• Design History File structure

• GSPR compliance matrix template

• Declaration of Conformity template

• Notified Body submission checklist

Tools

MDR Gap Analyzer

# Quick gap analysis

python scripts/mdr_gap_analyzer.py --device "Device Name" --class IIa

# JSON output for integration

python scripts/mdr_gap_analyzer.py --device "Device Name" --class III --output json

# Interactive assessment

python scripts/mdr_gap_analyzer.py --interactive

Analyzes device against MDR requirements, identifies compliance gaps, generates prioritized recommendations.

Output includes:

• Requirements checklist by category

• Gap identification with priorities

• Critical gap highlighting

• Compliance roadmap recommendations

Notified Body Interface

Selection Criteria

Factor

Considerations

Designation scope

Covers your device type

Capacity

Timeline for initial audit

Geographic reach

Markets you need to access

Technical expertise

Experience with your technology

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

• Validation: Internal gap assessment complete