Schedule:

Friday 21st of August at 8.30-12.00 and 
Friday 28th of August at 8.30-12.00.

Content of the Online Training

Day 1:
Scope and definitions

• Scope of the MDR 2017/745 and products that fall within the definition of a medical device
• Scope of the IVDR 2017/746 and products that fall within the definition of an in vitro diagnostic medical device

Economic Operators

• Who are they? What are their roles and responsibilities?
• A European authorized representative
• A distributor
• An importer
• A manufacturer
• A person responsible for regulatory compliance

Classification of medical devices under MDR and in vitro diagnostic medical devices under IVDR

• Intended purpose
• Qualification of medical device / in vitro diagnostic medical device
• Risk based classification
• Rules of medical device/ in vitro diagnostic medical device classification

Conformity assessment routes and the role of Notified Bodies

• Quality management system requirements and ISO 13485
• What is a Notified Body?
• Explanation of different conformity assessment routes
• CE marking

Day 2:

Key elements of technical documentation

• Device description and specification
• Information to be supplied by the manufacturer
• Design and manufacturing information
• General safety and performance requirements
• Benefit-risk analysis and risk management
• Product verification and validation
• Post-market surveillance

Clinical evidence

• MDR 2017/745: Clinical Evaluations
• Clinical performance
• Clinical investigations
• Post-market clinical follow-up
• IVDR 2017/746: Performance evaluations
• Scientific validity
• Analytical performance
• Clinical performance
• Performance studies
• Post-market performance follow-up

Post-market surveillance and vigilance

• Requirements after product launch e.g., information gathered by manufacturer in cooperation with other economic operators
• Reporting requirements of serious incidents and field safety corrective actions

Interactive elements can be included using e.g. Socrative, Kahoot or Mentimeter. Training will be held in English in Teams.