[FEATURED] EU’s First IVDR Expert Panel View Published
The very first expert panel opinion under the Medical Device Regulation was published this summer, but quickly withdrawn. Now, a new opinion, falling under the IVD Regulation, has been made […]
[FEATURED] Commission’s eIFU Draft Unleashes Diametrically Opposed Views Among Device Users
Industry wants to see the number of products for which electronic IFU are permitted to be expanded. But there is a strong lobby pushing for paper IFU to still be […]
[FEATURED] High-Risk Class D IVDs: Some Good News, Some Bad News About IVDR Implementation
The European Commission’s just updated Rolling Implementation Plan for the MDR and IVDR shows delays in key structures for high-risk IVDs. Recent guidance clarifies how and when these products can […]
