The new EU In Vitro Diagnostics Regulation is not all that new or very different from the original 20-year old In Vitro Diagnostics Directive. That’s the good news. The bad news : there will be a significant amount of work required to switch to the IVDR by 2022.
Very few and essentially just about all of the new requirements are simply enhancements that everyone is already in compliance with. What remains essentially the same from the IVDD with some enhancements and extensions include:
- Essential Requirements; renamed general requirements
- Technical documentation
- Common (technical) specifications;
- Conformity assessment;
- Registration;
- Notified Bodies;
- The European database EUDAMED; the current database will be extended
- Vigilance; is retained with extended requirements
The new aspects of this regulation include:
- Classes of devices
- Classification rules
- Post Market Surveillance (PMS)
- Unique Device Identification (UDI)
- Economic operators
- Requirement that at least one person in the organization be formally assigned responsibility for ensuring regulatory compliance
- Obligation to ensure persons who are offered genetic tests are informed about the significance and implications of the test
This webinar will accomplish several goals:
- Improve understanding of the regulation and its 2022 requirements
- Review the critical challenges that the new regulation poses
- Review potential implementation strategies
Why You Should Attend:
The IVD Regulation (2017/746) was enacted on 25 May 2017. This began the transition period of five years for manufacturers selling those devices within the EU. That transition period is up in May 2022. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements. That time is approaching quickly
This webinar will provide insight into the IVDR as well as how to tackle the transition.
Areas Covered in the Session :
- IVDR regulation overview
- Transition period and its implications
- Key changes overview
- Changes to rules to include classification and technical documentation
- Transition strategies
Who Should Attend:
- Regulatory Affairs Departments
- Compliance Departments
- Research and Development Departments
- Risk Managers
- Quality Departments
- Documentation Departments
- Medical Device Design Functions Professionals
- Auditors
- Medical Device Marketing Personnel
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