Led by Richard Young this high level 30 minute webinar will be provide you with valuable updates and insights into the new classification system proposed in the new IVD Regulation. You will gain solid grounding in the new risk based approach to classification so you can begin to evaluate your diagnostic products and prepare for the future changes.
- Regulatory update and impact on the IVD industry
- Outline of changes to classification: A risk based approach
- Reviewing Annex VII: Rule 1- 8