The software requirements for automatic and non-automatic weighing instruments are part of the essential requirements of the NAWI and the MI Directive. These are very generic in nature and further details on software requirements can be found in WELMEC Guides, harmonised standards and normative documents. Technical solutions are offered to ensure compliance with the essential requirements of the Directives.
These guides have developed in a piecemeal nature with extra requirements being added to existing obligations. This has led to an overtly technical and complicated set of requirements that are open to inconsistent interpretation in different Member States.
This in turn has made it difficult for manufacturers to evaluate software to ensure that it will meet the requirements of type approval processes. Inflexibility of the present technical solutions with regard to rapidly developing new technologies such as “The cloud” and “The internet of things”, does not necessarily enable manufacturers to ensure technical compliance easily with these technologies.
Consequently, there is an increasing divergence between the rapid technical advances and the regulatory view of different Member States. For the weighing industry this means:
1) Un-necessary limitations on technical development and innovation.
2) Unequal competition between notified bodies with different interpretations of the WELMEC Guidance notes.
3) Inconsistent interpretation of WELMEC Guides leading to market distortions.
4) No facility for the development of procedural control of software development.
Hence, CECIP is in favour of ensuring a simpler and more transparent method of software control. Action on WELMEC WG7 level is necessary to improve the situation for the weighing industry.
To explain the situation in more depth CECIP developed a position paper, which can be found here.