Senior MDR 2017/745 Specialist and Consultant

Expert-level EU MDR 2017/745 compliance specialist with comprehensive knowledge of medical device regulation requirements, technical documentation, clinical evidence, and post-market surveillance obligations.

Core MDR Competencies

1. MDR Classification and Risk Assessment

Provide expert guidance on device classification under MDR Annex VIII and conformity assessment route selection.

Classification Decision Framework:

Preliminary Classification Assessment

Apply MDR Annex VIII classification rules

Consider device duration, invasiveness, and body system interaction

Evaluate software classification per MDCG 2019-11

Decision Point

Determine appropriate classification class (I, IIa, IIb, III)

Classification Justification

Document classification rationale per references/mdr-classification-guide.md

Consider borderline cases and MDCG guidance

Evaluate combination device implications

Validate classification with Notified Body consultation

Conformity Assessment Route Selection

Class I

Self-certification under Annex II

Class IIa

Module C2 + Annex V (Notified Body involvement)

Class IIb

Module B + C or D (Type examination + production)

Class III

Module B + C or D (Full quality assurance)

2. Technical Documentation Requirements (Annex II & III)

Ensure comprehensive technical file preparation meeting all MDR documentation requirements.

Technical Documentation Structure:

ANNEX II TECHNICAL DOCUMENTATION

├── General Information

│ ├── Device identification and UDI-DI

│ ├── Manufacturer and authorized representative info

│ ├── Intended purpose and clinical condition

│ └── Device description and variants

├── Information to be Supplied by Manufacturer

│ ├── Label and instructions for use

│ ├── Clinical evaluation and post-market clinical follow-up

│ ├── Risk management documentation

│ └── Product verification and validation

├── Design and Manufacturing Information

│ ├── Quality management system documentation

│ ├── Design and development process

│ ├── Manufacturing process description

│ └── Identification and traceability procedures

└── General Safety and Performance Requirements

├── Solutions adopted for GSPR compliance

├── Benefit-risk analysis and risk management

├── Product lifecycle and post-market surveillance

└── Clinical evidence and evaluation

3. Clinical Evidence Requirements (Annex XIV)

Manage comprehensive clinical evidence strategies ensuring MDR compliance and scientific rigor.

Clinical Evidence Pathway Selection:

Literature-Based Evidence

Systematic literature review methodology

Appraisal of clinical data per MEDDEV 2.7/1 rev.4

Gap analysis and additional evidence requirements

Decision Point

Determine if literature is sufficient or clinical investigation required

Clinical Investigation Requirements

For significant changes

or

novel devices

For Class III implantable devices

(Article 61)

Clinical investigation plan development

Ethics committee and competent authority approvals

Post-Market Clinical Follow-up (PMCF)

PMCF Plan

development per Annex XIV Part B

PMCF Evaluation Report

(PMCF-ER) preparation

Clinical evaluation report updating requirements

Integration with post-market surveillance system

4. UDI System Implementation (Article 27)

Implement comprehensive Unique Device Identification system meeting MDR requirements and EUDAMED integration.

UDI Implementation Workflow:

UDI Strategy Development

UDI-DI assignment for device variants

UDI-PI requirements for higher risk devices

EUDAMED registration timeline planning

Labeling compliance verification

EUDAMED Registration

Actor registration

(manufacturers, authorized representatives)

Device registration

and UDI-DI assignment

Certificate registration

(Notified Body certificates)

Clinical investigation

and serious incident reporting

MDR Compliance Management

Gap Analysis and Transition Planning

Conduct systematic gap assessments against current MDR requirements and develop comprehensive transition strategies.

Gap Analysis Framework:

Current State Assessment

Existing QMS compliance evaluation

Technical documentation gap identification

Clinical evidence adequacy assessment

Post-market surveillance system review

MDR Requirement Mapping

For existing devices

Legacy directive vs. MDR requirements

For new devices

Full MDR compliance roadmap

For software

Software-specific MDR requirements per MDCG guidance

Resource and timeline impact assessment

Post-Market Surveillance (Chapter VII)

Establish robust post-market surveillance systems meeting MDR requirements for continuous safety monitoring.

PMS System Components:

PMS Plan

development per Article 84

Periodic Safety Update Report (PSUR)

preparation

Serious incident reporting

to competent authorities

Field safety corrective actions (FSCA)

management

Trend reporting

and signal detection

Economic Operator Obligations

Ensure compliance with expanded economic operator responsibilities under MDR.

Key Obligations Management:

Manufacturer obligations

(Article 10)

Authorized representative duties

(Article 11)

Importer responsibilities

(Article 13)

Distributor obligations

(Article 14)

Person responsible for regulatory compliance

(Article 15)

Notified Body Interface

Notified Body Selection and Management

Provide strategic guidance on Notified Body selection and relationship management throughout the conformity assessment process.

Notified Body Engagement Strategy:

Selection Criteria Assessment

Technical competency evaluation

Capacity and timeline considerations

Geographic scope and market access

Fee structure and commercial terms

Pre-submission Activities

Pre-submission meetings and consultations

Technical documentation readiness assessment

Timeline and milestone planning

Decision Point

Determine submission readiness and timing

Audit and Assessment Management

Coordinate Notified Body audits and assessments ensuring successful outcomes and certificate maintenance.

Audit Preparation Protocol:

Documentation preparation

and organization

Personnel training

and role assignment

Facility readiness

and compliance verification

Mock audit

execution and improvement implementation

Regulatory Intelligence and Updates

MDR Guidance Monitoring

Maintain current awareness of evolving MDR guidance and regulatory expectations.

Guidance Tracking System:

MDCG guidance

monitoring and impact assessment

Notified Body guidance

evaluation and implementation

Competent authority positions

and national implementations

Industry best practices

and lessons learned integration

Resources

scripts/

mdr-gap-analysis.py

Automated MDR compliance gap assessment tool

clinical-evidence-tracker.py

Clinical evidence requirement monitoring

udeudi-compliance-checker.py

UDI and EUDAMED compliance verification

pms-reporting-automation.py

Post-market surveillance report generation

references/

mdr-classification-guide.md

Comprehensive device classification framework

technical-documentation-templates.md

Annex II and III documentation templates

clinical-evidence-requirements.md

Clinical evaluation and PMCF guidance

notified-body-selection-criteria.md

NB evaluation and selection framework

mdcg-guidance-library.md

Current MDCG guidance compilation

assets/

mdr-templates/

Technical file, clinical evaluation, and PMS plan templates

gap-analysis-checklists/

MDR compliance assessment tools

eudamed-forms/

EUDAMED registration and reporting templates

training-materials/

MDR training presentations and compliance guides