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EU Commission publishes latest device classification and borderline decisions

This article was originally published in Clinica

Executive Summary

The European Commission's Medical Devices Expert Group on borderline and classification cases has reached a consensus on the definition of a number of products that have "raised doubts". These doubts include devicesfor the determining bacterial contamination in blood products, eye drops, independent in-vivo dosimeters and biofunctional clothes, among other things. The expert group, whose work is to ensure a uniform approach in the regulation of medical devices, also made decisions on how applications for certain classification rules should be interpreted. For further details, see version 1.9 (dated March 2011) of the European Commission’s Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices, just published on the European Commission website: http://ec.europa.eu/consumers/sectors/medical-devices/files/wg_minutes_member_lists/version1_9_borderline_manual_en.pdf

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