1 Technical Documentation Structure
The device-sector equivalent of the Pharmacovigilance System Master File (PSMF) is the Technical Documentation dossier required under EU MDR Annexes II and III. It is the single authoritative record reviewed by Notified Bodies during conformity assessment.
Device Description & Specification
Product variants, accessories, intended purpose, indications, patient population, and principles of operation.
Design & Manufacturing Information
Complete design history, manufacturing process descriptions, suppliers, sterilisation methods, and facility details.
Risk Management File (ISO 14971)
Hazard identification, risk estimation and evaluation, risk control measures, and residual risk acceptability.
Verification & Validation Results
Pre-clinical testing, bench tests, biocompatibility, software validation (IEC 62304), and usability engineering (IEC 62366).
Clinical Evaluation Report (CER)
Systematic review of clinical data demonstrating safety and performance conformity per MEDDEV 2.7/1 Rev. 4 methodology.
Post-Market Surveillance Plan
Proactive and reactive data collection strategy, PMCF studies, trend reporting, and PSUR/SSR schedules.
Instructions for Use (IFU)
User-facing documentation including labelling, contraindications, warnings, maintenance schedules, and disposal instructions.
2 PRRC vs. QPPV — Regulatory Role Comparison
While both roles serve as the designated regulatory contact, they originate from different legislative frameworks and carry distinct responsibilities.
- EU MDR Art. 15 — Legal basis under the Medical Device Regulation
- Checks conformity of devices before release to market, ensuring each device meets applicable requirements
- Ensures technical documentation and EU declaration of conformity are drawn up and kept up to date
- Fulfils post-market surveillance and vigilance obligations, including reporting under Art. 87
- May be an external subcontractor for micro and small enterprises (fewer than 50 employees)
- EU GVP Module I — Legal basis under Good Pharmacovigilance Practices
- Oversees the entire pharmacovigilance system, including ICSR collection, processing, and submission
- Responsible for signal detection, escalation to risk management, and regulatory authority liaison
- Must reside and operate in an EU/EEA member state and be continuously contactable (24/7 availability)
- Always internal to the Marketing Authorisation Holder — cannot be outsourced to a third party
3 Quality Management Cycle
A compliant quality management system follows a continuous four-phase cycle aligned with ISO 13485 and EU MDR Article 10 obligations.
4 CAPA Process for Medical Devices
The Corrective and Preventive Action (CAPA) process is the primary mechanism for translating identified deficiencies into systematic, verifiable improvements in device safety and performance.
Identify Deficiency
Complaint trends, audit findings, field safety reports, or signal detection triggers
Root Cause Analysis
Fishbone diagrams, fault tree analysis, 5-Whys applied to design and process factors
Corrective Action
Eliminate the root cause: e.g., adding mechanical lock-outs, redesigning connectors
Preventive Action
Prevent recurrence: color-coded UI elements, software forcing functions, design controls
Verify Effectiveness
Post-implementation monitoring, trend analysis, and updated risk management file
A CAPA in the medical device sector is a strategic response that may involve updating the device design to include mechanical lock-outs, color-coding the user interface, or adding forcing functions to software — going beyond process changes to fundamental design improvements.