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Medical Devices

Clinical Evaluation: Unifying Clinical Evaluation Requirements: Exploring ISO 18969 and the "New MEDDEV 2.7/1"

Tuesday, May 7, 2024
09:50 – 10:50 CEST
Location: B 07 + B 08
Learning Level: Advanced
Description: In the ever-evolving landscape of healthcare, harmonization and standardization have become paramount. This session delves into the world of clinical evaluation, where the experts of ISO TC194/WG4 are currently crafting a new global standard – ISO 18969. Tailored for professionals engaged in clinical affairs and clinical evaluation, this delivers a deep dive into the state of play regarding this new standard and seeks to provide valuable insights into the current development.

We will explore the driving forces behind ISO 18969, emphasizing the need for unification in an era where healthcare transcends borders. The session will offer a comprehensive overview of the standard's key components, shedding light on its implications for regulatory and clinical affairs professionals.
This involves looking at current guidances and regulatory requirements from different regions, such as European, US, Australian and Chinese requirements and the recommendations by IMDRF.

Moreover, we will discuss the challenges faced during the standard's formulation and the strategies employed to address them. Attendees will gain a nuanced understanding of the intricacies involved in developing a global standard that can adapt to diverse healthcare systems and practices.

We will also touch on the recent upgrade of MEDDEV 2.7/1 into a MDCG guidance.

Learning Objectives:

  • Upon completion of this session, participants should be able to describe the current status of ISO 18969 and the challenges in harmonizing the global requirements.
  • Upon completion of this session, participants should be able to explain how the standard may impact stakeholders and how to think ahead and prepare.
  • Upon completion of this session, participants should be able to react appropriately to implement potential changes of the "new MEDDEV 2.7/1".