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Getting ready for the EU MDR: Timelines for manufacturers
The MDR provides that GS1, HIBCC, and ICCBBA will be the issuing entities until the moment the European Commission adopts the corresponding implementing acts. As we approach the date of application of the MDR, it is key for manufacturers to ...

Medical Device and Diagnostics Industry

How to Keep Up with FDA's Expanding UDI Requirements
Medical Device and Diagnostics Industry
These UDIs must be issued by an FDA-accredited agency, such as GS1, HIBCC, or ICCBBA. In most cases, the step of acquiring a UDI has already been taken care of during previous UDI-related compliance deadlines. Manufacturers also must be sure to ...