As anticipated in a previous post the New Machinery EU Regulation 2023/1230 is out.
This will impact machinery manufacturers/importers/distributors and AI developers (software integrators), too.
👉Transitional period. Directive 2006/42/EC is repealed with effect from 14 January 2027. It means Member States shall not impede the making available on the market of products which were placed on the market in conformity with Directive 2006/42/EC before 14 January 2027. However, Chapter VI of the Regulation shall apply, from 13 July 2023, mutatis mutandis to such products instead of Article 11 of that Directive, including products for which a procedure has already been initiated under Article 11 of Directive 2006/42/EC.
👉 EC type-examination certificates and approval decisions issued in accordance with Article 12 of Directive 2006/42/EC shall remain valid until they expire.
👉 Expanded Scope. The new Regulation will expand the list of machinery with high-risk potential, now included in Annex I instead of Annex IV of the 2006/42 Machinery Directive. Manufacturers should expect dynamic updates to this list through delegated acts by the EU Commission.
👉Involvement of Notified Bodies. For machinery listed in Annex I Section A, a “notified body” will be required for conformity assessment and CE marking. This may lead to higher costs for assessments but emphasizes safety and compliance.
👉AI and Cybersecurity. The Regulation introduces health and safety requirements for AI and cybersecurity in machinery. Manufacturers must ensure protection against corruption, while autonomous control systems must stay within defined limits and allow for corrections at any time. Of course this aspect will be linked to the new AI Act Regulation.
👉Definitions and Obligations. The Regulation revises and updates definitions and obligations for manufacturers, importers, distributors, and authorized representatives, aligning them with current European law.
👉Enhanced Risk Reporting. Manufacturers will have an explicit obligation to notify regulators of risks in the field, strengthening the reporting process. Distributors also have new obligations, emphasizing collective responsibility for product safety.
👉Digital Instruction Handbooks. The new Regulation permits digital instruction handbooks as the default option, reducing paper usage. Printed instructions will be available only upon user request at the time of purchase, with exceptions for safety information for non-professional users.
If you want to assess your machines stewardship or you need a full AI readiness consultancy please contact us today.
Download the new EU Machinery Regulation here