UKM-SUM24-PG10-12_Layout 1 22/06/2024 12:56 Page 11
MACHINE BUILDING
additional two groups of machinery have been placed within Annex 1.A:
1. Safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions.
2. Machinery that has embedded systems with fully or partially self- evolving behaviour using machine learning approaches ensuring safety functions that have not been placed independently on the market, in respect only of those systems.
The new Machinery Regulation has mandated that all machinery listed within Annex 1.A. must receive a conformity assessment from a Notified Body. The practical implication of this is that manufacturers will need to consider applying for and carrying out these conformity assessments before the transition date to ensure that market access of these goods remains unhindered. Consideration should therefore be given to the availability of Notified Bodies to perform these
UKManufacturing Summer 2024
assessments. So, do not wait too long before applying for third-party conformity assessment.
High risk machinery groups within Annex 1.B can continue to be self-certified by the manufacturer. The machinery or related product must be designed and constructed in accordance with the harmonised standards, or common specifications specific to that category of machinery or related product which cover all the relevant EHSRs without deviation.
In addition to Notified Body Conformity Assessment by type-examination (module B) or Full Quality Assurance (module H), the Machinery Regulation also includes Unit Verification (module G). It stipulates separately the requirement for an ongoing responsibility for conformity assessment by the manufacturer through ‘conformity to type based on internal production control (module C)’. So, essentially type-examination is specifically for ‘series manufacture’ and Unit Verification for one-off builds.
MANUFACTURER, IMPORTER, AND DISTRIBUTOR OBLIGATIONS The scope of the new Machinery Regulation has also been expanded in comparison to
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