Whether European Medical Device Regulation (MDR) or other international regulations. For the medical technology industry, it is important to keep an eye on the latest developments in regulations
The threat of a medical device shortage on 27.5.2024 seems to have been averted. The EU is extending the deadlines for the introduction of the Medical Device Regulation (MDR). Nevertheless, the implementation of the MDR has been proceeding slowly since it came into force, and the European regulations from the MDR and IVDR have been a source of much discussion since then.
However, manufacturers who want to export must not lose sight of the regulations of the American FDA or the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). After all, Asia and North America are known as growth markets in medical technology.