The new In-Vitro Diagnostic Device Regulation (EU) 2017/746 came into force in May 2017 with a transition period of 5 years. The IVD Regulation is significantly different from the IVD Directive, including changed classification rules and requirements for conformity assessment. It is intended to strengthen the current approval system for in-vitro diagnostics, making substantial changes to the existing IVD Directive (98/79/EC) legislation.
The IVD Regulation introduces a new risk-rule classification system based on the Global Harmonization Task Force (GHTF) rules for classification which, for the first time, takes patient impact into consideration. This change to the classification system will have an impact on all manufacturers of IVDs. The majority of IVDs are currently self-declare devices but under the new regulation about 80% of IVDs require some form of conformity assessment by a Notified Body.
Practical workshops over the two days will help consolidate the information provided.
Why you should attend
By attending this course, you will:
- Gain a comprehensive overview of the new IVD regulation
- Be aware of how the role of the Notified Body will change under the IVD regulation
- Understand the requirements of the Technical Documentation for an IVD
- Plan your labelling requirements and strategies
- Know the key changes to ISO13485
- Learn how IVDSs are classified
- Understand the requirements for clinical evidence
- Know the vigilance and Post Market Surveillance (PMS) requirements for IVDS
Who should attend
- Regulatory affairs personnel
- Persons responsible for regulatory compliance
- Quality assurance professionals
- Those responsible for OEM/Subcontractor control of IVDs
- Economic operators, importers, distributors
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