MDR 2017/745 Specialist EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence. 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: 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