After 18 months of negotiations a new machinery regulation is finally approved. The expectation is that the Regulation will enter into force this summer. 42 months after that moment the current Directive will be repealed. In this article Certification Company reminds about the main changes that manufacturers and other economic operators should take into account.

1. Substantial modification

“Substantial modification” – is a new definition meaning the changes that were made to machinery (by physical or digital means) without manufacturer’s agreement and that no longer meet the relevant health and safety requirements.

‘substantial modification’ means a modification of a machinery product, by physical or digital means after that machinery product has been placed on the market or put into service, which is not foreseen by the manufacturer and as a result of which the compliance of the machinery product with the relevant essential health and safety requirements may be affected;

With a new Machinery Regulation substantial modification will be taken under control: they should be compliant with the essential health and safety requirements (Annex III). In this case the modifier will have the legal obligation and responsibility (Article 10) to conduct a conformity assessment before putting the modified machinery into service. Important to notice, that requirements will only apply with respect to the modified part of the machinery.

2. High-risk machinery

Due to the technical progress new classification rules for high-risk machinery products are introduced (Annex I). Be aware that the substantial modifications (for example, new software based on AI) may replace the machinery product to a high-risk machinery group. High-risk machinery has a specific conformity assessment procedure (Article 21 (2)) and only third party certification will be accepted.

3. Artificial Intelligence, the Internet of Things and robotics

Artificial intelligence, the Internet of things (IoT) and robotics raises new challenges in terms of product safety. Although the separate AI Regulation is expected, the risk assessment for the whole machinery with AI systems should be carried out using the Machinery Regulation. This should ensure the safe integration of the artificial intelligence system into the overall machinery.

4. User instructions

According to a new Machinery Regulation manufacturers are allowed to provide the user instructions in a digital format. However, upon purchaser’s request, the instructions shall be provided in hardcopy free of charge. The requirements to the digital instructions are mentioned in section 1.7.4 (Annex III). Due to the acceptance of the user instruction in a digital format the section 1.7.4.2 (c) of upcoming Machinery Regulation was also adjusted.

Besides this the requirements for user instructions content for machinery where product design allows emissions of hazardous substances where added (section 1.7.4.2 (w)).

What is next?

Certification Company stays up to date in regard to the development of Machinery Regulation and AI Regulation. Do you have any questions related to your product development? Do you want to know how new Regulation will affect your existing products? Contact us directly, our experts will be happy to assist you.