High risk machinery
Annex IV machines are now in Annex I
The Machinery Directive 2006/42/EC imposes conformity assessment procedures for machinery that have a high risk factor or which provide critical protection. It concerns 23 categories of machinery that are listed in Annex IV of the Directive, hence they are known as “Annex IV machinery”.
The Machinery Regulation (EU) 2023/1230 of 29 June 2023 will repeal the Machinery Directive by 20 January 2027. The same 23 categories of machinery that are listed in Annex IV of the machinery directive are now listed in Annex I of the machinery regulation. Plus 2 new categories: both machinery with embedded systems and safety components “with self-evolving behaviour using machine learning approaches ensuring safety functions”.
Conformity assessment procedures
The rules and options for the selection of possible conformity assessment procedures are given in Article 12 of the Machinery Directive 2006/42/EC c.q. Article 25 of the Machinery Regulation (EU) 2023/1230.
Details on the procedures can be found in the annexes of the machinery legislation, see the table below.
|#||Conformity assessment procedures||Module||2006/42/EC||(EU) 2023/1230|
|1||Internal Production Control||A||Annex VIII||Annex VI|
|2||EU Type-Examination + Conformity to Type based on Internal Production Control||B + C||Annex IX + Annex VIII.3||Annex VII + Annex VIII|
|3||Conformity based on Full Quality Assurance||H||Annex X||Annex IX|
|4||Conformity based on Unit Verification||G||-||Annex X|
Module A, also known as the “self-certification” procedure can only be chosen if the machine is in compliance with harmonised standards and those standards cover all of the relevant essential health and safety requirements.
This procedure does not require a Notified Body, all is done under responsibility of the manufacturer. The manufacturer creates the technical file, declares and ensures compliance with the relevant harmonised standards for all manufactured machines. For a few high risk machines this procedure is no longer possible under the Machinery Regulation.
Modules B + C can always be chosen. The EU Type-Examination procedure requires certification by a Notified Body of a representative model of the machine. The manufacturer remains responsible for conformity of all produced machines.
Module H can also always be chosen. For the Full Quality Assurance procedure a Notified will audit and certify the quality system for design, manufacture, final inspection and testing. The manufacturer is responsible for the safety assessment of the machines.
Module G is only available under the Machinery Regulation, it is not mentioned in the Machinery Directive. This procedure applies to a single machine (or a small batch). A notified body carries out appropriate examinations and tests, issues a certificate and affixes its identification number to the approved machine.