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The Commission said it will only be possible to make Eudamed operational when the system is fully functional and has been independently audited. Read More
The warning should note that breast implants have been associated with the risk of developing breast implant-associated anaplastic large cell lymphoma, the agency says. Read More
The FDA has categorized an internal therapeutic massager and an orthopedic surgical instrument used for osteochondral implants as Class II devices, assigning them special controls. Read More
South Korea has updated its medical device regulations to provide a pathway for innovative technologies such as artificial intelligence, robotics and 3D printing technology applied to medical devices. Read More