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ViewAttendees 11

IVD

Domain: Regulatory Frameworks & Strategy

Knowledge Area: General

IVDR – what are the implications for in-house in vitro devices for stakeholders and practical steps for implementation

Thursday, May 11, 2023
15:00 – 16:00 CEST
Location: Carmine & Charcoal

Supported By
Description: In-house in vitro devices have specific IVDR regulations requirements for use within a health institution (see article 5.5 of the IVDR) . The recent publication of MDCG 2023-1 “ Guidance on the Health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 “ provides more clarification. Where are the challenges for health institutions, patients and other stakeholders? What are the practical implications to market access for current IVD devices and on the In House Developed tests after 26 May 2022. Furthermore what are the consequence regarding for example innovation for new devices for rare diseases; how can they reach and stay on the EU market.

Learning Objectives:

  • IVDR changes and updates – EC updates 2022/ 2023
  • IVDR requirements for In-house devices – understanding the IVDR regulatory requirements and ways to navigate the MDCG guidance documents
  • Key stakeholders – there are many groups impacted in different ways
  • Practical steps to continue preparing for compliance within the health institutions
  • In house IVDs - Access and innovation aspects resulting from IVDR