In vitro diagnostic medical devices � Clinical performance studies using specimens from human subjects � Good study practice

2019 ◽  
Keyword(s):  
Performance Studies ◽  
Medical Devices ◽  
Clinical Performance ◽  
Human Subjects ◽  
In Vitro Diagnostic

scholarly journals Companion Diagnostics: State of the Art and New Regulations

2021 ◽  
Vol 16 ◽  
pp. 117727192110477
Author(s):  
Vasiliki Valla ◽  
Saba Alzabin ◽  
Angeliki Koukoura ◽  
Amy Lewis ◽  
Anne Ahlmann Nielsen ◽  
...  
Keyword(s):  
Medical Devices ◽  
Clinical Performance ◽  
The European Union ◽  
Companion Diagnostics ◽  
Scientific Validity ◽  
Wide Range ◽  
In Vitro Diagnostic ◽  
And Performance ◽  
Therapeutic Decision Making

Companion diagnostics (CDx) hail promise of improving the drug development process and precision medicine. However, there are various challenges involved in the clinical development and regulation of CDx, which are considered high-risk in vitro diagnostic medical devices given the role they play in therapeutic decision-making and the complications they may introduce with respect to their sensitivity and specificity. The European Union (E.U.) is currently in the process of bringing into effect in vitro Diagnostic Medical Devices Regulation (IVDR). The new Regulation is introducing a wide range of stringent requirements for scientific validity, analytical and clinical performance, as well as on post-market surveillance activities throughout the lifetime of in vitro diagnostics (IVD). Compliance with General Safety and Performance Requirements (GSPRs) adopts a risk-based approach, which is also the case for the new classification system. This changing regulatory framework has an impact on all stakeholders involved in the IVD Industry, including Authorized Representatives, Distributors, Importers, Notified Bodies, and Reference Laboratories and is expected to have a significant effect on the development of new CDx.

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