IVD: new deadlines and rules

IVD: New Deadlines, New Rules. Are You Ready for the Impact of the IVDR?

With the entry into force of Regulation (EU) 2024/1860, the regulatory framework for in vitro diagnostic (IVD) medical devices is undergoing a radical transformation. Extensions are available, but they are subject to strict conditions. Ignoring them could mean losing access to the market.

In this new video on the Isemed Channel, Matteo Placci, Operation Manager at ISEMED, provides clear guidance on:

• the new deadlines for "legacy" devices;
• the binding conditions required to benefit from the extensions;
• the updates to MDCG 2020-16 Rev. 4 regarding the classification of in vitro diagnostic (IVD) devices.

Who is this content for?

Manufacturers, RA Specialists, and Quality Assurance Managers looking to approach the IVDR transition with strategy and structure.

Watch the video to learn more 👇