Since 2023, IBExU UK Ltd. has been an approved body in accordance with Statutory Instrument 2016 No. 1107 as amended and is therefore authorized to carry out corresponding conformity assessment procedures. In addition the approved body is accredited by the National Accreditation Body for the United Kingdom (UKAS).
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 Statutory Instrument 2016 No. 1107 as amended, may only be placed on the market in Great Britain 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 specified in Regulation 39 of the Statutory Instrument 2016 No. 1107 as amended.
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 Schedule 3A, Part 1 of the Statutory Instrument 2016 No. 1107 as amended (Type Examination; same as Module B of Directive 2014/34/EU). In individual cases, with equipment or protective systems the conformity assessment procedure in accordance with Schedule 3A, Part 7 of the Statutory Instrument 2016 No. 1107 as amended (Conformity based on unit verification; same as Module G of Directive 2014/34/EU) can also be carried out. In this regard, step 2 – the conformity assessment procedure for the quality assurance system – is not applicable.
Conformity assessment procedures on quality assurance systems (Step 2)
The type examination certificates issued in step 1 in accordance with Schedule 3A, Part 1 of the Statutory Instrument 2016 No. 1107 as amended form the basis for the implementation of conformity assessment procedures on quality assurance systems. These are as a rule carried out in accordance with Schedule 3A, Part 2 (Conformity to type based on quality assurance of the production process; same as Module D of Directive 2014/34/EU) or Part 5 (Conformity to type based on product quality assurance; same as Module E of Directive 2014/34/EU) of the Statutory Instrument 2016 No. 1107 as amended.
Placing products on the market – obligations of the manufacturer
Where the 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 Declaration of Conformity for the equipment or protective system and affixes to each piece of equipment or protective system the UKCA marking including the ID number of the approved 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 Schedule 3A, Part 7 of the Statutory Instrument 2016 No. 1107 as amended.
Where the 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 ID number of the approved 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 Schedule 3A, Part 1 of the Statutory Instrument 2016 No. 1107 as amended, then Schedule 3A, Part 6 of the Statutory Instrument 2016 No. 1107 as amended (Internal production control; same as Module A of Directive 2014/34/EU) is to be applied. In this regard, for equipment in accordance with Part 3, Regulation 39, Clause (1) b) ii) a retention of the documentation with an approved body is necessary.
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