2013/172/EU: Commission Recommendation of 5 April 2013 on a common framework for ... (32013H0172)
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2013/172/EU: Commission Recommendation of 5 April 2013 on a common framework for a unique device identification system of medical devices in the Union Text with EEA relevance
- COMMISSION RECOMMENDATION
- of 5 April 2013
- on a common framework for a unique device identification system of medical devices in the Union
- (Text with EEA relevance)
- (2013/172/EU)
- 1.
- INTRODUCTION
- Purpose of the Recommendation
- Scope of the Recommendation
- International activity on UDI
- European activity on UDI
- 2.
- RATIONALE
- Improvement of incident reporting
- Efficient recalls and other field safety corrective actions
- Efficient post market actions by national competent authorities
- Queries in numerous data systems
- Reduction of medical errors
- 3.
- DEFINITIONS
- 4.
- RISK BASED APPROACH
- UDI type
- UDI application
- 5.
- CONDITIONS TO BE FULFILLED BY ECONOMIC OPERATORS, HEALTH INSTITUTIONS AND PROFESSIONAL USERS
- Manufacturers
- Importers
- Authorised representatives
- Distributors
- Health institutions
- Professional users
- 6.
- UDI NATIONAL DATABASES
- Data elements
- ANNEX
- DATA ELEMENTS OF THE NATIONAL UDI DATABASES
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