Last edit: 27/05/2023
After a few years in the “kitchen”, the first draft of the new machinery directive saw the light in April 2021. There are 3 entities at European Level:
– The Commission: it is the Technical harm of the EU institution
– The Council: it is the Political harm, representing the governments in each EU contry
– The Parliament. Directly elected by the European Citizens
The original text was proposed by the Commission. A revised text, proposed by the Council, was publised in June 2022. The final text was formally approved on the 22nd May 2023 and it is translated into all the languages of European Union. You can find it in the attachments to this page. Let’s see what are the key changes contained in the latest proposal and compared with the 2006/42/EC.
Why a revision of the machinery directive?
Because of the importance of Cobots.
The commission wants to make sure that the new Machinery Regulation, and consequently the harmonised technical standards, properly assess applications using collaborative robots. The concern is that, on one side, those application result unsafe since the Harmonised standards are not properly updated and, on the other side, that the either the Machinery Product Regulation (MPR) or the harmonised Standards do not hamper the full development of this new and important economic trend.
[New M.P.R. – May 2023 Text] – 1.1. Reasons for and objectives of the proposal
(12) Recently, more advanced machinery, which is less dependent on human operators, has been introduced on the market. Such machinery is working on defined tasks and in structured environments, yet it can learn to perform new actions in this context and become more autonomous. Further refinements to machinery, already in place or to be expected, include real-time processing of information, problem solving, mobility, sensor systems, learning, adaptability, and capability of operating in unstructured environments (for example construction sites). The Commission Report on the safety and liability implications of Artificial Intelligence, the Internet of Things and Robotics of 19 February 2020, states that the emergence of new digital technologies, like artificial intelligence, the Internet of things and robotics, raises new challenges in terms of product safety. The report concludes that the current product safety legislation, including Directive 2006/42/EC, contains a number of gaps in this respect that need to be addressed. Thus, this Regulation should cover the safety risks stemming from new digital technologies.
Because they want to clarify the definition of Partly Completed Machinery.
A common misunderstanding is that a robot without an end effector is a PCM, while a robot with an and effector is a machinery because the latter can “in itself perform a specific application”.
In reality both are partly completed machinery. The MPR wants to clarify that aspect as well.
[New M.P.R.] – 1.1. Reasons for and objectives of the proposal
[…] With respect to the definitions set by the Directive, the definition of ‘partly completed machinery’ raised a number of concerns particularly centered at the borderline with the definition of ‘machinery’ and the definition of ‘machinery’ has been clarified.
Because they want to favour the use of digital tools for the Information for use (estimated € 16.6 billion savings in printing costs of instructions, each year).
ISO 12100 requires the Instruction Manual to be printed on paper. The new EN ISO 20607 allows the use of a digital format. The new regulation wants to allow and favour the use of, not only digital formats for the manual but also the development of videos that are a better format to explain aspects of the machinery than text or pictures.
[New M.P.R.] – 1.1. Reasons for and objectives of the proposal
[…] The MD requires manufacturers to provide the necessary machinery information, such as instructions. To ensure that every machine user has access to the instructions, providing a printed version was considered as the most viable option. Since then, however, the use of the internet and digital technologies has increased. The requirement to provide printed versions increases the costs and administrative burdens for economic operators and has a negative impact on the environment. However, it must be also considered that some users are less digitally savvy, there is a lack of internet access in certain environments and the digital manual might not match the version of the product.
The new structure of the Machinery Directive
At the moment, the Machinery Products Regulation proposed text has different Annexes compared with today’s text.
For example, if the text stays as it is, we shall change our todays language from:
“does the manufacturer gives you a IIA or a IIB declaration?” To “does the manufacturer gives you VA or a VB declaration?”
THE MACHINERY PRODUCTS REGULATION
- 76 Whereas
- 52 Articles
- Annex I – Categories of machinery or related products to which the procedures referred to in Article 21 (2) shall be applied
- Annex II – Indicative list of safety components
- Annex III – Essential health and safety requirements relating to the design and construction of machinery or related products
- Annex IV – Technical documentaion
- Annex V – EU declaration of conformity and incorporation
- Annex VI – Internal production control
- Annex VII – EU Type-Examination
- Annex VIII – Conformity to type based on internal production control
- Annex IX – Conformity based on full Quality Assurance
- Annex X – Assembly instructions for partly completed machinery
THE MACHINERY DIRECTIVE
- 30 Whereas
- 29 Articles
- Annex I – Essential health and safety requirements relating to the the design and construction of machinery
- Annex II – Declarations
- Annex III – CE marking
- Annex IV – Categories of machinery to which one of the procedures referred to in Article 12(3) and (4) must be applied
- Annex V – Indicative list of the safety components referred to in Article 2(c)
- Annex VI – Assembly instructions for partly completed machinery
- Annex VII – Technical files / technical documentation
- Annex VIII – Assembly instructions for partly completed machinery
- Annex IX – EC type-examination
- Annex X – Full quality assurance
- Annex XI – Minimum criteria to be taken into account by Member States for the notification of bodies
- Annex XII – Correlation table with Directive 98/37/EC