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CEN and CENELEC receive draft standards mandate on IVDs

This article was originally published in Clinica

Executive Summary

CEN and CENELEC have received a draft mandate from the European Commission to develop a programme of standards needed to support the IVD-MD Directive, currently in draft. In response, CEN BTS 3 Healthcare has set up an ad hoc group to co-ordinate programming. It will liaise with CEN TC 140 and CENELEC TCs 62 and 66 to draw up a list of proposed standards which will indicate conformity with the Essential Requirements of the Directive. It plans to complete the proposed programme by November, after which it will be sent to the Commission for approval.

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