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IVDs

IVDR Track Closing Panel: What Are The Remaining Challenges for IVDR?

Wednesday, May 8, 2024
15:40 - 16:40 CEST
Location: C 01
Learning Level: Intermediate

Description: IVDR was first published in May 2017 and date of application passed in May 2022. The step change from the IVD Directive 98/79/EC to Regulation (EU) 2017/746 has proven to be especially challenging for the diagnostics industry when compared to the more mature EU regulatory experience for the device industry tackling transition from 93/42/EC MDD to (EU) 2017/745 MDR.

All stakeholders have experienced steep learning curves when trying to implement IVDR. Key issues have been device classification, transition timelines, Notified Body capacity and technical documentation and clinical evidence requirements. Specific devices have also been challenged with additional requirements such as Class D, companion diagnostics, near patient tests and distance sales. Many IVD manufacturers still face interacting with a Notified Body for the first time while others are approaching their first IVDR certificate renewal and second cycle of certification with enhanced technical documentation surveillance.

On 23 January 2024 the European Commission published a proposal to amend the transitional provisions for (EU) 2017/746. The proposal allows an additional 2 years for each classification transition timeline as well as extensions to the validity of IVDD certificates if certain conditions are met.
This closing panel will reflect upon what has worked well in IVDR transition so far and will consider the remaining challenges, including identifying emerging issues that need to be resolved.

Learning Objectives:

  • Understand the status of key IVDR transition issues.
  • Understand the status of emerging IVDR transition issues.
  • Understand how to effectively address IVDR transition issues by identifying best practice