Achieving IVDR Compliance for Legacy IVD Devices

Many In Vitro Diagnostic (IVD) manufacturers have been trading for years under the In Vitro Diagnostic Medical Devices Directive (IVDD), most of which were self-declared devices. New rules under the EU IVDR (2017/746) mean that the vast majority of these devices will now require certification by a notified body to legally remain on the EU market. The EU has provided extended deadlines for different classes of IVDs, allowing more time to achieve compliance. This webinar provides an overview of the transitional timelines and the key IVDR requirements manufacturers must comply with to keep their devices on the market.

Objectives

This webinar will help you:

• Gain awareness of the transitional timelines
• Understand the IVDR requirements
• Explore strategies for achieving compliance

Agenda

The webinar covers the following:

• Introduction
• What is a legacy device?
• Transitional timelines
• Key new IVDR requirements and strategies for compliance:
• Quality management system
• Performance evaluation
• Risk management
• Post market surveillance
• IFU and labelling
• UDI
• Notified body surveillance of IVDD devices

Language: English
Cost: No Charge