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Software Guide (Measuring Instruments 2014/32/EU) also applicable to 2004/22/EU


Note: The newest version of WELMEC Guide 7 "Software" considers the latest experience gained from the applications of the Guide and is therefore the official version confirmed by the WELMEC Committee. Older versions are made available for reference purposes only.


The document provides guidance to all those concerned with the application of the Measuring Instruments Directive (MID), especially for software-equipped measuring instruments. It addresses both, manufacturers of measuring instruments and notified bodies which are responsible for conformity assessment of MID instruments. By following the Guide, a compliance with the software-related requirements contained in the MID (e.g. Annex I, 7.6, 8.3, 8.4) can be assumed, and it can be further assumed that all notified bodies will accept this Guide as a compliant interpretation of the MID with respect to software.

The Guide in hand is based on the “Software Requirements and Validation Guide”, Version 1.00, 29 October 2004, developed and delivered by the European Growth Network “MID-Software”. The Network was supported from January 2002 to December 2004 by the EU commission under the contract number G7RT-CT-2001-05064.
The Guide is purely advisory and does not itself impose any restrictions or additional technical requirements beyond those contained in the MID. Alternative approaches may be acceptable, but the guidance provided in this document represents the considered view of WELMEC as to a good practice to be followed.
Although the Guide is oriented on instruments included in the regulations of the MID, the results are of a general nature and may be applied beyond.
The newest version considers the latest experience gained from the applications of the Guide.

AUTHORED BY: Working Group 7

Unless otherwise stated, the English version of each publication should be taken as the official version.

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