The Council of the EU, the European Parliament and the European Commission have reached an agreement on the Machinery Products Regulation. The new legislation transforms the 2006 Machinery Directive into a regulation.
The new Machinery Regulation is expected to be published in July 2023, although the exact date has not yet been announced. The regulation enters into force in all member states 20 days after its publication in the Official Journal of the EU. From the official entry into force of the regulation, a 42-month transition period begins. After the transition period, the implementation of the regulation will become mandatory.
"With the adoption of the new Machinery Regulation, the European Union is adapting its regulatory provisions to the new technologies and the risks associated with their use for the safety of users," commented Eng. Blagovesta Shineva, manager of CTEC.
Major changes in the new regulation
The new regulation contains numerous changes aimed at the safety of machines, which must be observed by manufacturers and other economic operators. A mandatory conformity assessment by a notified body, such as CTEC - notified body number 1871, is provided for, applicable to six categories of "high risk" products specified in Annex I of the Regulation.
The rules introduce new safety requirements for autonomous machines, human-machine collaboration and, for the first time, the safe use of artificial intelligence systems in machines.
It is expected to reduce the administrative burden and costs for producers. The rules introduce administrative simplifications, such as allowing digital formats for user instructions.
The new Regulation establishes clear and proportionate rules that will apply uniformly throughout the EU and increases legal certainty for manufacturers. More effective market surveillance will also be established. The new rules align the safeguards against non-conforming machinery products with those used in the wider EU legislative framework on products.
CTEC plans to organize a series of trainings aimed at preparing manufacturers in the machinery sector and other interested economic operators for the changes and new requirements set out in the Machinery Regulation.