Impact of European Union Medical Device Regulation on Medical Device Innovation
The European Union (EU) has recently implemented a new medical device regulation (MDR) to ensure the safety and effectiveness of medical devices used in the EU. This regulation has had a significant impact on the medical device industry, particularly in terms of innovation. The MDR requires that all medical devices must be approved by the European Commission before they can be sold in the EU. This approval process is more rigorous than before, and it requires manufacturers to provide evidence of safety and efficacy. This has led to an increase