EU HTAR is coming for medical devices and IVDs: What manufacturers should know
Published on April 4, 2025
The EU HTA regulation is expanding beyond pharma to include device and IVD manufacturers in 2025. JCAs will soon become mandatory for high-risk devices. Manufacturers must prepare now for what’s coming or face difficulties later.
The European Union Health Technology Assessment Regulation (EU HTAR) 2021/2282, adopted in December 2021 and in force since January 2022, will impact medical devices and in vitro diagnostics (IVDs) in 2025.
What’s changing for devices in 2025?
The regulation will extend beyond pharmaceuticals and now cover specific high-risk medical devices and IVDs, introducing Joint Clinical…
