Course Overview
The In-Vitro Diagnostic Regulation (EU) 2017/746, which came into force in May 2017 with a transition period of five years, is intended to strengthen the current approval system for in-vitro diagnostics and makes substantial changes to the existing IVD Directive (98/79/EC) legislation.
The Regulation introduces a new risk-rule classification system based on the Global Harmonization Task Force (GHTF) rules which, for the first time, takes patient impact into consideration. This will have a significant impact on all manufacturers of IVDs as about 80 per cent of all devices will now require some form of conformity assessment by a Notified Body.
This course will clarify the requirements applicable to in-vitro diagnostic devices under the new Regulation, highlight the major changes to responsibility and product data expectations and provide a thorough understanding of the impact on the industry.
Practical workshops over the two days will help consolidate the information provided.
CPD Hours: 12
Course Content
- Day 1
- Introduction to IVDs
- Historical overview of the current IVD Directive (98/79/EC)
- Introduction to IVD Regulation (EU) 2017/746
- Notified Bodies
- IVD Regulation - key changes
- Compiling the technical documentation for an IVD
- Labelling requirements and strategies
- Day 2
- ISO 13485:2016
- Risk-based classification
- Workshop: Product classification
- Risk management
- Workshop: Risk management
- Clinical evidence and common specifications
- Vigilance and PMS
- Case studies: Reporting/recalls
- Key timelines and practical considerations
- Discussion: Preparing a roadmap for transition
