The European Commission has made available the final report of the impact assessment which is intended to provide the directions to update the Machinery Directive.
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The final report of the Impact assessment study on the revision of the Machinery Directive (Directive 2006/42/EC) was made available at the end of August. This assessment was developed under different options to provide a clear direction of where the work should go, with the following specific objectives:
- Ensure the clarity of the scope and its link with other directives;
- Align the Directive to the New Legislative Framework (Decision 768/2008);
- Preserve the technology neutral principle allowing the use of innovative technologies as far as safety is ensured;
- Reduce administrative requirements related to documentation; and
- Cover new risks related to digital emerging technologies
The assessment is focusing mainly on:
- collaborative robots (robots which may be working close to the operator), with the need to adapt the requirements related to the risk of contact with components as well as the mental health risk related to such use
- Artificial Intelligence (AI) and Machine Learning (ML). On this subject, the study has shown the difficulty to have a clear view due to the limited background (limited technologies of AI available, accident data not necessarily reported in Europe, limited information found in North America over the last years). The prerequisite condition of carrying out the full risk assessment of a ML before putting it into service was considered as an issue, as the ML will adapt its behaviour throughout time.
- software updates, when they generate a modified behaviour of the machine. If this is under the responsibility of the manufacturer of the machine when he provides the software updates, the situation is unclear when they are placed on the market on their own.
- The study proposes to state clearly in the subclause dealing with safety and reliability of control systems of the Machinery Directive that external influences include cyberattacks. For other aspects of cybersecurity, there seems to be an agreement to have them covered in a horizontal regulation
- the revision of Annex IV of the Machinery Directive, dealing with high-risk machinery, to suggest the removal of internal checks from the manufacturer for the conformity assessment of the product. This would be replaced by inspections carried out by a third party. The list of machines given in this annex should also be re-considered frequently.
- the definition of partly completed machinery (PCM), to provide more clarity and avoid confusion with components or with interchangeable equipment
The assessment will be the basis, together with the feedback provided by Members States on the revision of this directive, for the discussions to be held during the Commission Expert Group on the Machinery directive (potentially on 9-10 November).
For CEMA, these points are already well taken into account in the present version; facts and data should be the basis for further modifications.