What is the primary purpose of the Medical Device Regulation (MDR)?

The primary purpose of the Medical Device Regulation (MDR) is to ensure the safety and efficacy of medical devices within the European Union. This regulation sets comprehensive standards and requirements that manufacturers must adhere to in order to market their products. By enforcing stringent evaluation processes and clinical assessments, the MDR aims to protect patient health and safety, thereby fostering public confidence in medical devices.

The focus on safety and efficacy is critical because it means that devices must not only meet specific performance standards but also be thoroughly tested for potential risks. This ensures that health care providers and patients can use these devices with confidence, knowing that they have been rigorously evaluated.

While promoting the sale of medical devices globally, streamlining the approval process, and providing funding for research are important aspects within the broader context of healthcare and medical device development, they do not capture the fundamental objective of the MDR. The primary emphasis is firmly placed on safeguarding public health by regulating how devices are developed, assessed, and monitored in the market.