From the term "jointly" in the definition of equipment in the Directive (Article 2(1)) it follows that a product, is formed by combining two or more pieces of equipment, together with components if necessary and together with other parts as necessary, that are electrically and mechanically interconnected to create a completely functional assembly, has to be considered as a product falling under the scope of Directive 2014/34/EU.
This combined product or assembly must be placed on the market
and/or put into service by a responsible person (who will then be the manufacturer of
that assembly) as a single functional unit.
Such assemblies may not be ready for use but require proper installation. The
instructions (Annex II, 1.0.6.) shall take this into account in such a way that
compliance with Directive 2014/34/EU is ensured without any further conformity
assessment provided the installer has correctly followed the instructions.
In the case of an assembly consisting of different compliant pieces of equipment as
defined by Directive 2014/34/EU which were previously placed on the market by
different manufacturers these items of equipment have to conform with the Directive,
including being subject to proper conformity assessment, CE-marking, etc. The
manufacturer of the assembly may presume conformity of these pieces of equipment
and may restrict his own risk assessment of the assembly to those additional ignition
and other relevant hazards (as defined in Annex II) which become relevant because
of the final combination. If there are additional ignition hazards, a further conformity
assessment of the assembly regarding these additional risks is necessary. Likewise,
the assembler may presume the conformity of components which are accompanied
by a written attestation of conformity issued by their manufacturer (Article 6(2)) (see
also obligations of manufacturers).
However, if the manufacturer of the assembly integrates parts without CE marking
into the assembly (because they are parts manufactured by himself or parts he has
received from his supplier in view of further processing by himself) or components not
accompanied by the written attestation of conformity, he shall not presume conformity
of those parts and his conformity assessment of the assembly shall cover those parts
as required.
Note that the manufacturer's own risk assessment does not necessarily preclude the
use of notified bodies in the applicable conformity assessment procedure(s). If the equipment is Zone 0 Mechanical or Zone 0 or 1 Electrical a notified body must be engaged
1. In order to clarify the concept of "assembly" in the sense of Directive, a valve, actuator, solenoid, switch box and sensor intended for use in potentially explosive atmospheres can be used as an example.
1. a) For the purposes of Directive 2014/34/EU, a valve, actuator, solenoid, switch box and sensor constitutes a single item of equipment with respect to the ignition hazard, i.e. the a valve, actuator, solenoid, switch box and sensor cannot be considered separately for the purposes of assessing explosion risk(s). In this case, the unit as a whole has to undergo the conformity assessment procedure of electrical and non-electrical equipment. The same applies e.g. for an electrical ventilating fan where the fan is an integral part of the motor or a pump and motor
2. a) In some cases the valve, actuator, solenoid, switch box and sensor can be considered separately although they form a functional unit. If in this case there is no additional ignition hazard as a result of assembling the valve, actuator, solenoid, switch box and sensor, this functional unit as a whole does not constitute a single item of equipment which falls within the scope of Directive 2014/34/EU. It is then to be considered a combination of "individual items of equipment" in terms of explosion protection. In this case, therefore, the manufacturer of valve, actuator, solenoid, switch box and sensor must supply an EU declaration of conformity for each of both items.
2. b) If there is an additional ignition hazard as a result of assembling valve, actuator, solenoid, switch box and sensor, or if one item is not already in full conformity with the Directive, the assembly has to undergo the complete conformity assessment procedure appropriate for the category
Note; Think Static, Mechanically Generated Sparks or Hot Spots as these could easily be a new hazard that have been introduced
The manufacturer who assembles the equipment assumes responsibility for the compliance of the combined product with the Directive as supplies;
The EU declaration of conformity, as well as the instructions for use must refer to the assembly as a whole. It must be clear (e.g. by enclosing a list of all parts and/or a list
of the safety related data) which is/are the combination(s) that form(s) the
assemblies. The manufacturer assumes responsibility for compliance with the
Directive, and must therefore, in accordance with Annex II 1.0.6, provide clear
instructions for assembly/installation/operation/maintenance etc. in the instructions
for use.
If you have any questions regarding assemblies please feel free to contact me via the contact page https://www.cemarkingauthority.com/contact