Testing / certifications in accordance
with Directive 2014/34/EU

03.11.2015

Applicable as of 20/04/2016

  • As European notified body in accordance with Directive 2014/34/EU
  • As test laboratory and certification centre, accredited by the German Accreditation Body (DAkkS)
  • Equipment
  • Protective systems
  • Components
  • Quality assurance systems (QA systems)

Since 1997, the IBExU Institut für Sicherheitstechnik GmbH has been a notified / approved European centre in accordance with Directive 94/9/EC and as of 20/04/2016 an European notified body in accordance with Directive 2014/34/EU and is therefore authorised to carry out corresponding conformity assessment procedures. In addition the test laboratory as well as the certification centre are accredited by the German Accreditation Body (DAkkS).

Conformity assessment procedures consist of an examination with subsequent evaluation and, in the case of a positive result, a certification. Differentiation is made between conformity assessment procedures on products (Step 1) and quality assurance systems (Step 2). As a rule, products which are subject to the Directive 2014/34/EU may only be placed on the European market after the implementation of steps 1 and 2.

The selection of the conformity assessment procedure to be applied is defined by the respective product and is elucidated in Article 13 of the Directive 2014/34/EU.

Conformity assessment procedures on products (Step 1)

In the case of products, differentiation is in principle made between equipment, protective systems and components. As a rule conformity assessment procedures on products are carried out in accordance with Annex III of the Directive 2014/34/EU (Module B: EU-type examination).

In individual cases, with equipment or protective systems the conformity assessment procedure in accordance with Annex IX of the Directive 2014/34/EU (Module G: Conformity based on unit verification) can also be carried out. In this regard, step 2 – the conformity assessment procedure for the quality assurance system – is not applicable.

Certificates which have been issued in accordance with Directive 94/9/EC, Annex III or IX keep their validity.

Conformity assessment procedures on quality assurance systems (Step 2)

The EU-type examination certificates issued in step 1 in accordance with Annex III of the Directive 2014/34/EU form the basis for the implementation of conformity assessment procedures on quality assurance systems. These are as a rule carried out in accordance with Annex IV (Module D: Conformity to type based on quality assurance of the production process) or Annex VII (Module E: Conformity to type based on product quality assurance) of the Directive 2014/34/EU.

The date which is given in the certificates issued in accordance with Directive 94/9/EC remains unaffected by the Directive revision.

Placing products on the market – obligations of the manufacturer

Where the EU-type examination certificate exists for an equipment or protective system together with the valid certificate for the quality assurance system in the appropriate field of application then the manufacturer issues the corresponding EU Declaration of Conformity for the equipment or protective system and affixes to each piece of equipment or protective system the CE marking including the EU ID number of the notified body which carried out the conformity assessment procedure on the quality assurance system (Step 2). The same applies to equipment or protective systems which have been subjected to individual testing in accordance with Annex IX of the Directive 2014/34/EU.

Where the EU-type examination certificate exists for a component together with the valid certificate for the quality assurance system in the appropriate field of application then the manufacturer issues the corresponding certificate of conformity for the component and affixes to each component the EU ID number of the notified body which carried out the conformity assessment procedure on the quality assurance system (Step 2).

In the case of equipment which is not subject to testing in accordance with Annex III of the Directive 2014/34/EU then Annex VIII of the Directive 2014/34/EU (Module A: Internal production control) is to be applied. In this regard, for equipment in accordance with Chapter 3, Article 13, Clause (1) b) ii) a retention of the documentation with a notified body is necessary.

The retention of already stored documentation in accordance with Directive 94/9/EC remains persistent.