The date of application of MDR of 26th May 2020 has long been recognised as a very ambitious target by many in the medical devices sector. The pressure among stakeholders whether they be economic operators, notified bodies or competent authorities to be ready in time has been intense. The delay of Eudamed and the well-documented issues around capacity in the Notified Body network are just two examples of areas of difficulty in being ready for MDR implementation.
We hope that you find this essential guide to be useful.
Acorn Regulatory has been at the forefront of the MDR issue. The Essential Guide to MDR looks at the issue from a range of perspectives. Our expert MDR team has also written several whitepapers on the issue and they can be accessed here.