Manufacturers of medical devices must often service and repair products once they are out in the field. If these device are involved in a future complaint investigation, matters become complicated. Dennis Gucciardo, associate at Hogan Lovells, explained the concerns involved and the struggles that companies face in completing investigations in these situations during the MedTech Intelligence 2015 Integrated Complaint Management conference.
The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health…
The updated guidance clarifies how the program applies to medical devices that may address health inequities, as well as those that may increase access to care or provide a non-addictive treatment option to treat pain or addiction. It also clarifies…
In addition to challenges brought by new EU MDR, Switzerland has struggled to approve and introduce new devices due to its revised national medical device ordinance, which created even tougher import hurdles.
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