Unique device identification and traceability for medical software: A major challenge for manufacturers in an ever-evolving marketplace

Author:

Bianchini Elisabetta,Francesconi MartinaORCID,Testa Marisa,Tanase Maya,Gemignani Vincenzo

Publisher

Elsevier BV

Subject

Health Informatics,Computer Science Applications

Reference23 articles.

1. Evaluation of the unique device identification system and an approach for medical device tracking;Bayrak;Heal. Policy Technol.,2017

2. IMDRF UDI Working and Group, UDI Guidance Unique Device Identification (UDI) of Medical Devices, Copyr. © 2013 by Int. Med. Device Regul. Forum., 2013.

3. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and Council Directives 90/385/EEC and 93/42/EEC.

4. International Trade Centre, [Online] Available: http://www.intracen.org/Part-3-Difference-between-standards-and-technical-regulations/ (accessed 21.01.19).

5. Technical standards | International Cooperation and Development, [Online] Available: https://ec.europa.eu/europeaid/sectors/economic-growth/trade/technical-standards_en (accessed 21.01.19).

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