THE IMPACT OF THE NEW REGULATION: REDESIGN AND TECHNICAL RIGOR
The transition from Directive to Regulation means absolute uniformity throughout the European Union, with no room for local interpretations. However, the real challenge lies in the new Essential Health and Safety Requirements (EHSRs), which now include cybersecurity, artificial intelligence, and software management. For manufacturers, this could result in a redesign of control systems and significantly more complex technical documentation.
A critical element of the analysis concerns the conformity assessment procedures. The new Regulation expands the list of high-risk machinery (Annex I) for which self-certification will no longer be sufficient.
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ECM – Ente Certificazione Macchine is informed of the existence of fakes/counterfeit certificates/laboratory test reports/other ECM documents relating to certain European Directives or International Standards. No one has permission to issue certificates or other documents in our name and on our behalf, so ECM will take action against any companies that issue certificates/documents without authorization.
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To consult the updated list of reports of misuse of the name Ente Certificazione Macchine srl and/or the notified body number 1282, click here.
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IMPORTANT NOTICE: Immediate suspension of the use of the product “Hyperbaric chamber”
We would like to inform all our valued customers and business partners of an urgent measure that requires the utmost attention and timely cooperation from all users.