EIGA Publishes a new Position Paper on Medical Devices Regulation
EIGA Position Paper PP 42/16 - EIGA High Level Contribution on the Proposal for Medical Devices Regulation - Revision of Directive 93/42/EEC
EIGA has issued this new publication
EIGA welcomes the revision of the current Medical Devices Directive (MDD) and its replacement with the proposed Medical Devices Regulation (MDR), of which the primary objectives are to deliver a consistently high level of health and safety protection, allow free and fair trade of products through the EU and adapt legislation to technological and scientific progress.
EIGA requests that medical gases, used as medical devices should be excluded from Rule 21 of the proposed MDR concerning substance-based invasive devices. This is because under Rule 21, medical carbon dioxide and other medical gases, where they are used for insufflation would be reclassified to Class III devices, with consequences that run counter to the primary objectives of the revision of the Directive.
The reasons for EIGA's request are detailed in the Position Paper which has been developed by experts from EIGA's Medical Gases Council and approved by the EIGA Board of Directors.
This publication can be viewed or downloaded on the EIGA Website by clicking here. You can view or download many other EIGA publications at the following address: www.eiga.eu.
5 May 2016