ICER Set to Evaluate Non-Drug Products in 2020
The Boston-based Institute for Clinical and Economic Review (ICER), an independent research organization that conducts health technology assessments...
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2024 IVDR Sprint
How to Adopt a Proactive Approach to Ensure Timely Compliance with the Applicable Deadlines
The In-Vitro Diagnostic (IVD) industry plays a pivotal role in modern healthcare by providing crucial information for patient management. In Europe, the IVD landscape is currently undergoing a significant transformation with the implementation of the In-Vitro Diagnostic Regulation (IVDR). The IVDR, adopted by the European Union (EU), aims to enhance the safety and performance of IVDs while ensuring greater transparency and traceability throughout the product life cycle.
In the transition from the Directive to the Regulation, manufacturers face several challenges that must be addressed through meticulous planning and implementation of a strategic action plan. These challenges collectively shape the landscape in which IVD manufacturers must currently operate, to overcome hurdles and achieve compliance with the evolving regulatory framework, and include:
- Reclassification of Devices
- Stringent Regulatory Compliance
- Increased Clinical Evidence Requirements
- Notified Body Availability
- Educational Challenges and Time Constraints
- Challenges Related to Specific Devices (e.g. CDx, LDT, NPT)
By proactively keeping abreast of industry developments and staying attuned to the latest challenges and advancements, Veranex leads you through the journey of recognizing, prioritizing, and overseeing activities throughout the entire process of achieving IVDR compliance. Our commitment and experience of 20+ years ensures that your business aligns with all pertinent industry standards and government regulations.
During this recorded webinar, you will:
- Acquire insights into the In Vitro Diagnostic Regulation (IVDR) landscape.
- Comprehend how IVDR requirements aid organizations in fulfilling legal and regulatory obligations associated with In Vitro Diagnostics (IVD) compliance in the EU market.
- Develop familiarity with fundamental concepts and principles of IVD classification, the conformity assessment process, technical documentation, and clinical evidence requirements.
- Additionally, gain a basic knowledge of specific requirements for IVDs not previously defined by the former In Vitro Diagnostic Directive (IVDD), including Companion Diagnostics (CDx), In-House Devices, and Near-Patient Testing Devices (NPTs).
Please submit the form to watch the webinar: