EU Regulation Recap: A Look At Scope And Definitions In New EU Rules
The EU takes a breather over its summer months after an intense period of discussion about the future Medical Device and IVD Regulations. Taking a broad overview of the new regulatory texts, what do we know about the key changes they will bring? This piece looks at the most noteworthy elements of the MDR and IVDR scope and definitions sections. Look for recaps of other sections in the weeks ahead.