Google trend - MDR

MDR - 10 things to know with detail

• MDR stands for Medical Device Regulation, which is a set of regulations that govern the manufacture, distribution, and sale of medical devices in the European Union.
• The MDR was adopted in 2017 and will replace the existing Medical Device Directive (MDD) in May 2021.
• The MDR aims to improve the safety and performance of medical devices, increase transparency and traceability, and strengthen the regulatory framework for medical devices.
• One of the key changes introduced by the MDR is the requirement for greater clinical evidence to support the safety and efficacy of medical devices.
• Under the MDR, medical device manufacturers will be required to provide more detailed information about the design, manufacturing process, and performance of their devices.
• The MDR also introduces new requirements for post-market surveillance, vigilance reporting, and market surveillance to ensure that medical devices continue to meet safety and performance standards once they are on the market.
• The MDR applies to a wide range of medical devices, including implants, diagnostic devices, and software used for medical purposes.
• The MDR also introduces new classification rules for medical devices based on their risk level, with stricter requirements for higher-risk devices.
• Compliance with the MDR is mandatory for all medical device manufacturers selling products in the European Union, regardless of where the devices are manufactured.
• Non-compliance with the MDR can result in fines, product recalls, or even suspension of market access for medical devices. It is important for manufacturers to understand and comply with the requirements of the MDR to avoid these consequences.