Scientific Validity Reports: a mandatory requirement for In Vitro Diagnostic Regulation (IVDR)
In vitro diagnostics (IVDs) play a critical role in diagnosis, proper treatment decisions, and monitoring patient outcomes. The European Union’s new In Vitro Diagnostic Regulation (IVDR) introduces significant changes for IVD manufacturers, necessitating a comprehensive understanding of the regulatory approval requirements to market a product in Europe. The requirements now include clinical and scientific evidence to support the validity of the IVD, as has been standard for reviews of therapeutic products for many years. Manufacturers should familiarize themselves with the key regulatory changes and adhere to the transition timelines specified by the IVDR to ensure compliance and continued access to the European market for their IVDs.
Related Insights
Blog
FDA’s final guidance on renal impairment: Assessment of the regulatory approach to inform clinical development planning
Oct 23, 2024
Playbook
Are you using real-world evidence?
Feb 1, 2023
Article
8 things you need to know about eCTDs in China
Jul 1, 2022
Blog
Preparing for the New Era of Hybrid Regulatory Inspections
Jul 11, 2022
Article
EU Orphan Drug Designation – overcoming regulatory challenges
Jul 20, 2022
Video
Cell & Gene Therapies: A Regulatory Update
Jul 22, 2022
Blog
U.S. drug price reform of 2022: What does the Inflation Reduction Act mean for drug manufacturers?
Aug 17, 2022
Article
Q&A Project Optimus: What you need to know
Oct 11, 2022
Article
Relyvrio Approval: Lessons Learned
Oct 31, 2022
Article
Five strategies for meeting the requirements of Project Optimus and improving the chances of approval
Nov 10, 2022
Video
How to transition existing trials under EU-CTR
Feb 1, 2023
Blog
Maintaining Data Integrity for Quality and Compliance – Essential Despite Pandemic Disruptions
May 16, 2022
Related Insights
Blog
FDA’s final guidance on renal impairment: Assessment of the regulatory approach to inform clinical development planning
Oct 23, 2024
Playbook
Are you using real-world evidence?
Feb 1, 2023
Article
8 things you need to know about eCTDs in China
Jul 1, 2022
Blog
Preparing for the New Era of Hybrid Regulatory Inspections
Jul 11, 2022
Article
EU Orphan Drug Designation – overcoming regulatory challenges
Jul 20, 2022
Video
Cell & Gene Therapies: A Regulatory Update
Jul 22, 2022
Blog
U.S. drug price reform of 2022: What does the Inflation Reduction Act mean for drug manufacturers?
Aug 17, 2022
Article
Q&A Project Optimus: What you need to know
Oct 11, 2022
Article
Relyvrio Approval: Lessons Learned
Oct 31, 2022
Article
Five strategies for meeting the requirements of Project Optimus and improving the chances of approval
Nov 10, 2022
Video
How to transition existing trials under EU-CTR
Feb 1, 2023
Blog
Maintaining Data Integrity for Quality and Compliance – Essential Despite Pandemic Disruptions
May 16, 2022