Although medical device manufacturers have more time to prepare due to the delayed EU MDR deadline, this shouldn’t distract from the extensive documentation they must compile in the meantime to prove their devices are compliant.
A recap of a recent effort involving a small group of AIDC experts in devising a data integrity scheme suitable for protecting a new device identifier used in modern healthcare applications against mis-keying. It presents the group’s undertakings in researching solutions to ensure identifier integrity, the challenges encountered, and how a more complete understanding of the constraints of the intended application led to a departure from the initial design and resulted in the elegant solution that exists today.
Timely compliance will ensure that your products will not be considered misbranded.
UK and European manufacturers should put a UDI implementation plan in place ASAP.
The agency has posted new education modules about the unique device identification rule.