A recently passed law by the European Commission (EC), meant to improve safety standards for medical devices in Europe, has led manufacturers to pull life-saving products from the shelves for failing to meet the new criteria.
This has led to a massive bottleneck, as thousands of medical devices seek re-approval before the 2024 deadline, according to latest data.
The European Union’s Medical Devices Regulation (MDR) act, which came into effect on May 2021, required that all medical devices ranging from implants and prosthetics, to blood glucose meters and catheters, to meet the stricter safety standards.
Under the new regulations, previously approved products under the old system must undergo new clinical trials….