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UDI book "Unique Device Identification"
Basics, practical solutions, answers for manufacturers, clinics and users of medical devices and in-vitro diagnostics
The 257-page UDI book by author Heinrich Oehlmann describes the implementation of UDI in accordance with the regulations for labelling and data registration for medical devices and in-vitro diagnostics. It contains descriptions of the accredited barcode labelling systems with practical tips for selection of most suitable codes and the criteria for registration in the officially managed databases in the USA and Europe. In addition, the obligations of manufacturers, importers, distributors and hospitals from the legal texts for medical devices (MDR) and IVD products (IvDR) are interpreted. Implementation guidance includes the general use of linear barcode, 2D codes and RFID for automatic data capture and how to derive practical benefit from the obligations.
This information is intended for manufacturers as well as for hospital management and it’s quality and IT officers.

The UDI Book II is available in print and as an e-book in German language:
ISBN 978-3-410-29843-4, ISBN (e-book) 978-3-410-29844-1

A reading sample can be accessed here:

UDI Buch II 201125 1MB