The aim of this course is to provide Learners with knowledge and understanding of the additional requirements within the Medical Device Regulation (MDR), as well as of the current directives (MDD 93/42/EE) and ISO 13485:2016, including the terminology used and the certification requirements.
Course Content:
SESSION 1: SCOPE, DEFINITIONS AND CLASSIFICATIONS
Scope of the MDR
Relevant MDR definitions
Delegated and implementing acts
Common specifications
Scope of classification under the MDR
SESSION 2: CONFORMITY ASSESSMENT PROCEDURES
Conformity assessment procedures
Certification process requirements within MDR
Additional requirements under MDR Annex XII
EU declaration of conformity
Criteria for notified bodies and how this is achieved
SESSION 3: QMS REQUIREMENTS
QMS and regulations
QMS application
QMS audit
QMS surveillance
SESSION 4: GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
GSPR matrix
GS & PRs vs MDD ERs
SESSION 5: TECHNICAL DOCUMENTATION REQUIREMENTS
Technical documentation requirements
Conformity assessment
SESSION 6: CLINICAL EVIDENCE REQUIREMENTS
Clinical evaluation
Clinical investigations
Post-market clinical follow-up
Clinical evaluation plan
SESSION 7: POST-MARKET SURVEILLANCE AND VIGILANCE
Post-market surveillance life cycle
Guidance documents
Post-market surveillance plan
PMCF
PMCF study
SESSION 8: RISK MANAGEMENT REQUIREMENTS
General safety and performance requirements
Usability review
Design life cycle
SESSION 9: IDENTIFICATION AND TRACEABILITY
Traceability of devices
Identification in supply chain
Unique device identifiers and the UDI system
SESSION 10: SUPPLY CHAIN REQUIREMENTS
Economic operators and their general obligations
Other economic operators
Systems and procedure packs
SESSION 11: TRANSITION AND NEXT STEPS
Transition requirements
Transition plan
SESSION 12: IBUSINESS IMPACT, TIMELINE AND PORTFOLIO PLANNING
Step 1: Understand the detail of the MDR.
Step 2: Project Planning
