Technical Bulletin
TB 49 / 23 - Medical Gas Pipeline Systems: Purpose (Channelling versus Administration) and Applicable MDR Requirements
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A Medical Gas Pipeline System (MGPS) is a singular medical device, and this type of equipment has been put into service in several countries under the Medical Device Directive 93/42/EEC (MDD). However, the conformity assessment and classification have not been harmonised across EU Member States.
With the introduction of the MDR, the requirements applying to the MGPS need to be appropriately assessed because of potential implications.
This publication provides guidance on which MDR rules apply, resulting in a class IIa classification.