Implementation Training for the EU MDR (Medical Device Regulation 2017/745)

Introduction to the EU Medical Device Regulation (EU MDR)

• Reasons driving the European MDR
• The transition timeline
• Major entities and roles in the EU MDR
• Overview of major requirements in the EU MDR
• Quality management system linkages

EU MDR Acts

• EU MDR Implementing Acts and other updates

Quality Management System Requirements

• Impact of the EU MDR and EN ISO 13485:2016 on the quality management system (QMS)
• Relationship between ISO 13485 and EN ISO 13485
• QMS requirements in the EU MDR
• Roles and responsibilities for QMS implementation and requirements
• Describe a roadmap for EU MDR compliance and EN ISO 13485:2016 conformance

Workshop! Assessment of EU MDR QMS Requirements

Premarket Activities

• The risk-based approach to classification for medical devices in the EU MDR
• Device classification and classification rules
• Conformity assessment routes
• Additional requirements for high-risk devices

Workshop! Assess Impact of Premarket Requirements

Technical Documentation

• EU MDR changes from the existing technical file requirements
• Technical documentation structure / contents
• Requirements found in the general safety and performance requirements (Annex I)
• Technical documentation and postmarket surveillance
• Role of common specifications (CS) and harmonized standards
• Use of life-cycle management strategies to maintain device compliance to the EU MDR

Workshop! Examine and Apply Selected GSPR Requirements

Workshop! Assess Technical Documentation Requirements

Common Specifications and Standards

• Role of common specifications (CS) and harmonized standards
• Use of life-cycle management strategies to maintain device compliance to the EU MDR

Clinical Evaluation

• Role of MEDDEV 2.7/1 rev. 4 in EU MDR compliance EU MDR and:
  1. Clinical evaluation
  2. Device equivalence
  3. Clinical evidence
  4. Clinical literature searches
  5. Clinical investigations
  6. Clinical investigation data system
  7. Reporting clinical investigation adverse events
  8. Clinical evaluation report(CER)
  9. Postmarket clinical follow-up (PMCF)

Workshop! Clinical Evaluation Requirements

Unique Device Identification (UDI)

• UDI traceability requirements in the EU MDR
• UDI responsibilities and impacts on economic operators
• UDI electronic system and EUDAMED
• Global impacts of UDI systems

Exercise! UDI Assignment and Placement

Postmarket Activities

• EU MDR postmarket requirements in Annex III Part B (technical documentation)
• EU MDR postmarket surveillance system and reporting requirements including vigilance reporting, trend reporting, serious incidents and field safety action
• Role of the EUDAMED database in postmarket surveillance 

Workshop! Postmarket Surveillance Requirements

Impact on Auditing

• EU MDR requirements for Notified Bodies and their impact on manufacturers
• Describe how Notified Bodies audit under the EU MDR, including assessing the QMS, technical documentation, clinical evaluation, and performing product verification
• Certification under the EU MDR, including:
  1. Surveillance assessments
  2. Unannounced audits
• Impact of Notified Body requirements on internal audits

Workshop! Develop a Strategy for Notified Body Audits of Selected Activities

EU MDR Implementation

• Steps to prepare for implementation of the EU MDR
• Link internal audit function to EU MDR implementation planning
• Best practices for EU MDR planning and implementation

Group Activity! Identify responsibilities for planning the EU MDR implementation