Are you ready for the IVDR? Regulatory impact and milestones for CE marking
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About this course
Reasons to attend
This interactive webinar is developed to help in vitro diagnostic medical device manufacturers understand the basics of the impact of the new In-vitro diagnostic regulation (IVDR), the most relevant changes against the directive, and how it will impact either medical devices already in the market and new medical devices.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
- Live online training: 2h (10h00 – 12h00)
Course Description
The In Vitro Diagnostics Regulation (EU) 2017/746 entered into force on May 26th, 2017 as the replacement of Directive on In Vitro Diagnostic Medical Devices (98/79/EC).This regulation, fully applicable from May 26th, 2022, have the aim to increase safety and efficiency in the EU medical device market. Within the key changes expected, there is a product scope expansion as IVD and a reclassification of these devices according to their risk. In addition, the clinical evidence to demonstrate clinical benefit and safety will be rigorously evaluated according to risk class.This regulatory framework causes a burden for IVD manufacturers, who will have to address the requirements to maintain their already marketed products or to place their IVDs on the market. To know which will be the impact of the regulation and the main requirements to comply with will be key to assure continuity in the European market.Programme highlight
- Scope of IVDs under IVDR: What is and what is not an IVD under IVDR
- Classification and Conformity Assessment Procedures
- Concepts and rules in IVD classification
- Routes of conformity assessment
- Special additional procedures:
- Commons Specifications and EU Reference Laboratories
- Companion Diagnostics
- Economic Operators, Traceability and Registration of IVDs
- CE marking milestones
- General Safety and Performance Requirements for IVDs
- Clinical Evidence, Performance Evaluation and Performance Studies
- Post-market Surveillance
Learning objectives
- Obtain a clear understanding of the challenges of the In vitro diagnostic Regulation and how important is to be prepared to the date of application
- Learn about the routes of conformity assessment and the role of notified bodies
- Understand the classification system and how to properly classify your device
- Recognize in early stages of the development the regulatory and quality requirements to comply with according the device’s risk class
- Raise awareness on the importance of defining a good regulatory strategy to optimize time to market
Who should attend
IVD designers, manufacturers, Clinical Project Managers, Quality Management, Regulatory Affairs and/or Vigilance responsibles
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (3)
- Clinical Studies Operations (GCPs or ISO 14155) (0)
- Study and Site Management (0)
- Data Management and Informatics (0)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
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