Orgalim Policy Exchange: The Machinery Regulation – Impact on our industries

31 March 2023

More than 200 participants joined Orgalim’s Policy Exchange yesterday to hear the latest on the EU Machinery Regulation as it progresses towards implementation. The new Regulation is due to enter into force this July and apply from January 2027, which gives all sides just 42 months to get ready. Our webinar brought together experts from the European Commission, industry, market surveillance authorities and standards bodies to share insights into what to expect and how best to prepare.

With this being such a key piece of legislation for Europe’s technology industries, much is at stake, as Orgalim Policy Director and moderator, Daniel Wennick, emphasised. "It is very important for our industries to have a smooth transition to the new Regulation, to reduce the implementation costs and safeguard competitiveness," he said.

To that end, the discussion focused firstly on the timeline, second on the key changes coming up, and third on what is being done, and needs to be done, to ensure a smooth implementation.

On the timeline, Mehdi Hocine, Head of Unit, Machinery and Equipment, European Commission, DG GROW, pointed out in his keynote address that some provisions of the new Regulation will already kick in before January 2027, while the obligation for Member States to report accident data applies after 24 months. The Commission will update the Guide to application of the Machinery Regulation, but it will be some time before it is available – there is no timeline for it yet, he said. Streamlined safety procedures will apply immediately upon entry into force.

Among the key changes that companies will need to prepare for are the digitalisation of instructions, safety provisions relating to AI and cyber safety, and mandatory third-party assessment for six product categories. Mr Hocine assured that "we have clear and transparent criteria to populate the list of products that will be subject to mandatory conformity assessment by third parties." Fundamentally, the shift from a Directive to a Regulation should bring greater legal certainty, with less room for interpretation by Member States, he said.

We have clear and transparent criteria to populate the list of products that will be subject to mandatory conformity assessment by third parties.

Mehdi Hocine

The other panellists shared their insights into the preparations for implementation. Representing industry, Thomas Kraus, Chair of Orgalim’s Machinery Task Force, and Advisor Technical Affairs, EU Regulations at Orgalim member VDMA, spoke of the work that is going on proactively in the Machinery Expert Group, for example, to clarify some of the new requirements. "While many of the new requirements are clear, some require further clarity," he said. He also stressed Orgalim’s commitment to contributing to the Editorial Group for the planned update of the Guide, which he welcomed as "important not only for the legal certainty but also for the competitiveness of all the industry sectors under the Orgalim roof."

Maureen Logghe, speaking as President of the European Cooperation of Accreditation, and also as head of the market surveillance authorities and notifying authorities, emphasised that, while the new Regulation is very welcome, the increasing volume of horizontal legislation at the EU level is increasing complexity for the authorities and appealed for support from industry. "Knowing our markets well enables us to better focus the market surveillance and for that we need the help of Orgalim and its members," she stressed.

Francisco Luis Arribas Martín, Project Manager Industry and Equipment at Spanish association for standardisation, UNE, flagged the huge amount of work ahead to adapt over 700 harmonised standards to the new Regulation and warned that "we will need a minimum of three years from the adoption of the legislative act and very likely more time" to get it done. Indeed, Mr Hocine acknowledged that the smooth transition of so many harmonised standards is the biggest challenge ahead, especially as timing is tight. He emphasised that the input from Orgalim experts channelled through CEN and CENELEC will be key to ensure the standardisation requests are made as quickly as possible.

Questions from the audience yielded further insights on how companies should prepare. In the immediate future, "the Orgalim Machinery Task Force will continue to drive discussions to ensure a smooth transition” says Helena Le Goff-Jedrzejowicz, secretariat lead for the Orgalim Machinery Task Force. "We strongly believe that the new framework will support the machinery sector to move towards sustainability and digitalisation goals."

Another pertinent question is about how to have timely interpretation of the new HAS requirements before the updated guide is ready? Orgalim's Adviser @HelenLeGoff joins to put forward key questions from the audience.#Machinery4EU #EUIndustry pic.twitter.com/Ni0AjB2Ksq
— Orgalim (@Orgalim_EU) March 30, 2023