White Paper: Laboratory Developed Tests: Overview of the Regulatory Framework in Europe vs. USA
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Near-patient testing (NPT) devices face substantial challenges under the new IVDR, including:
- New Stringent Regulatory Constraints due to IVDR
- Risk-Based Approach for Usability and Human Factors, including Use Environment
- Expectations from Notified Bodies
In this recorded webinar, Lydie Moreau and Juan Roman from Veranex, and Laura Scrivano from TÜV SÜD GmbH help you to:
- Acquire insights into the landscape requirements of the In-Vitro Diagnostic Regulation (IVDR) related to Near Patient Testing.
- Comprehend how usability, human factors and use environment support in fulfilling regulatory obligations associated with the compliance of IVDs in the EU market.
- Receive input from a Notified Body on gaps observed and expectations.
Please submit the form to watch the webinar:
Laboratory Developed Tests: Overview of the Regulatory Framework in Europe vs. USA
In this white paper, our regulatory team presents the frameworks governing Laboratory Developed Tests in Europe and the USA, and discuss...
