It is the traditional summer break in Europe. But the volume of concerns being expressed by medtech players around the Medical Device Regulation’s 26 May 2024 compliance deadline is increasing.
The Hard Deadline
Manufacturers of medical devices and of many IVDs, including of new and legacy products, have a hard deadline of 26 May...
Stakeholders are fearful that many products will remain uncertified under the new regulation’s still-tight timelines, often due to system failures rather than manufacturer shortfalls. They worry this will result in...