A guide into stress-free product compliance

Annex IV machines

Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.

Annex IV machine is a commonly used term

But which machines are they and is Notified Body involvement always mandatory?

Machines mentioned

It concerns the machines that are listed in Annex IV of Machinery Directive 2006/42/EC. 

Please make sure to use the current consolidated version. Annex IV contains more than 20 high-risk machines, to name a few: circular saws, chainsaws, presses, moulding machines, and vehicle maintenance lifts.

Assessment procedures

Article 12 of machinery directive 2006/42/EC states three possible conformity assessment procedures. 

The first 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 of Annex I.

The second and third procedure can always be chosen.

  1. The procedure with internal checks on the manufacture of machinery (Annex VIII); 
  2. The EC type-examination procedure (Annex IX) plus internal checks on manufacturing (Annex VIII, point 3); 
  3. The full quality assurance procedure (Annex X).

Notified Bodies

The procedures in Annex IX and Annex X require the involvement of a Notified Body. 

A complete list of all Notified Bodies is kept in the NANDO database.

EC type-examination means that the Notified Body will test and certify a representative model of the machine. The manufacturer remains responsible for conformity of all produced machines.

Full quality assurance means that the 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.

The “internal check” of Annex VIII does not require a Notified Body, all is done by the manufacturer. The manufacturer creates the technical file, declares and ensures compliance with the relevant requirements of the machinery directive for all manufactured machines. 

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