UDI for Medical Devices Used in the Gas Industry
Doc. 227/20 Unique Device Identifier (UDI) for Medical Devices Used in the Gas Industry
The new European regulation EU 2017/745 on Medical Devices, (MDR) will come into full application on 26th May 2020 and replaces the current Directive 93/42/EEC. It introduces, among others, totally new requirements concerning the registration and traceability of medical devices put on the market via an identification system based on a Unique Device Identifier (UDI).
This publication applies to the medical devices put on the market by the gas manufacturers according to the new medical device regulation EU 2017/745 and concerns the implementation of the requirements related to the UDI system.
This publication has been prepared to enable EIGA members to understand the overall UDI system and to efficiently implement these new requirements for the medical devices they are putting on the market as the legal manufacturer in compliance with the regulatory timeframe. It addresses the production of the UDI, the associated labelling and the registration of the medical devices in the UDI - EUDAMED database with a focus on the specificities of medical device gases and medical pipeline systems.
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Table of Contents
1 Introduction
2 Scope and purpose
2.1 Scope
2.2 Purpose
3 Definitions
3.1 Publication terminology
3.2 Technical definitions
4 EUDAMED database: registration of the operator and devices
5 Understanding UDI
5.1 General overview
5.2 Content of the Basic-UDI-DI
5.3 Content of the UDI-DI
5.4 Content of the UDI-PI
5.5 Legacy devices
6 Label characteristics
7 Issuing entities
8 Implementation dates
9 Application of the UDI to the gases industry
9.1 Application of the UDI to cylinders and dewars
9.2 Applying UDI to liquid gases delivered by cryogenic tankers
9.3 For Medical Device gases in bulk or loose
9.4 Applying UDI to medical gas pipeline systems and similar installations
9.5 For medical gas pipeline systems
10 Updating the Quality System
11 References
Appendix 1 – Nomenclature
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Fonte: EIGA
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