The European Commission announces the legal text will be a Regulation


On 23 and 24 March 2021 the recently created Machinery Expert Group, replacing the Machinery Directive Working Group, met for the first time. During the meeting the main plans were presented  and discussions on how to consider pressure equipment assemblies were held. 

On the first day the European Commission unveiled the final main modifications envisioned for the Machinery Directive:  

  • the new text will be a Regulation
  • it will also intend to cover new technologies for machinery

Artificial Intelligence 

In particular on Artificial Intelligence (AI) new requirements are planned to be included when it impacts safety:a machinery containing AI ensuring a safety function will be considered as a high-risk machinery, and will require a validation by a third party.

Substantial modification 

The notion of “substantial modification” (i.e. a modification brought to a machine – for example, an update of a software, which would generate new behaviour of the machine) would be introduced. For this specific case, the EC plans to propose a simplified conformity assessment. On that, industry stakeholders showed concerns considering these provisions will imply the need for the original manufacturer to provide confidential information to the modifier  

No longer self-conformity assessment for high-risk machinery 

The principles related to high-risk machinery were modified with the removal of the possibility to proceed to self-conformity under specific conditions. A validation done by a third party would now be mandatory for high-risk machinery. Besides the Commission will be empowered to update the list of high-risk machinery through Delegated Acts, using new criteria which are still under discussion. 

User manual under digital format mainly but not only 

The instructions will be able to be provided under digital format although the paper format may be requested by the customer when the machine is sold.

Next steps:the European Commission intends to submit to the European Parliament and the Council of the European Union legislative proposal by the end of April or beginning of May 2021. The publication of the Machinery Regulation is expected by the beginning of 2023. More than four years should be left to manufacturers and standardisation bodies to update machinery and harmonised standards.

Day 2 deals with pressure equipment assemblies 

For clarification, a pressure equipment assembly is a system containing several pressure equipment components (vessels, pipings, pressure accessories that can be used for example in hydraulic systems of a front loader).

Today,a pressure equipment assembly placed on the market and put into service must be validated by a notified body as stated in the Pressure Equipment Directive (PED) 2014/68/EC. However, this rule does not apply when pressure equipment components of a category higher than category I are included in a machinery: in this case, the Machinery Directive requires the manufacturer to cover the risk of break-up during operation and the validation will be ensured through the self-compliance principle.

What could be the change? 

The group dealing with market surveillance on Pressure Equipment (ADCO Group Pressure Equipment) requested for an equivalent assessment through a Notified Body, as it considered there is a legal difference between both directives. 

Reacting to this point, industry stakeholders stressed out the extra cost third-party testing will incur for manufacturers. This requirement will apply to most of the machines placed on the market. 

The Commission proposed to comply with the technical requirements given in the PED, and to follow the conformity assessment described in the Machinery Directive.  

Further discussions will take place on this issue.