In order to assess conformity of a product with the applicable safety requirements of a technical regulation, the manufacturer or supplier of a product may be required (depending on the type of product) to either draw up a declaration of conformity (DoC) or to undergo product certification procedure. In order to draw up a DoC, the manufacturer or supplier is required to follow one of the six conformity assessment modules (for some products the choice of modules may be restricted by the legislation).
The procedure for drawing up a DoC is essentially similar to the certification procedure. However, when issuing a DoC, the manufacturer or supplier may prove conformity of a product with the safety requirements by using their own evidence, instead of involving an independent EEU-accredited laboratory or center. This option is only available for some conformity assessment modules.
This module is to be used for goods that are mass-produced in the EEU. The module prescribes the following steps:
- expert assessment of the products performed at the manufacturer’s discretion;
- regular inspection of the production process performed by the manufacturer itself.
Only the manufacturer or its authorised representative registered in the EEU is allowed to draw up a DoC if this module is used.
This module is used when only one batch of products or even one product unit is to be supplied. This module prescribes only one quality control measure – the submission of proof that the product in question complies with the applicable technical regulation, based on the results of product expert assessment.
The relevant tests are performed at the applicant’s discretion.
Either the manufacturer or supplier may act as the applicant.
This module is to be used for mass-produced goods. The goods may either be imported or manufactured in the EAEU. The difference of Module 3D from 1D is that Module 3D requires that the expert assessment of product samples is only performed by a laboratory accredited in the EAEU.
Module 3D requires the following steps:
- laboratory expert assessment in a specialised laboratory or center accredited in the EAEU;
- regular self-monitoring of production process performed by the manufacturer.
Either the manufacturer or its authorised representative registered in the EAEU may submit a declaration application if Module 3D is applied.
This module is intended for a single product unit or for a batch of products. In order to obtain a conformity declaration, it is required to perform tests of product samples in an EAEU accredited laboratory. It is not required to perform primary or regular self-monitoring of the manufacturing process.
Either the supplier or manufacturer may submit the application for a conformity declaration if this module is applied. In this case, the declaration is registered by submitting a notification to the registration body.
If a product is not being positioned as a finished product but rather as a base or a component of a finished product, the declaration is issued for the product type. Consequently, sample tests are performed taking this fact into consideration.
Module 5D includes the following quality assessment measures:
- expert assessment of the product in an EAEU accredited laboratory; and
- regular monitoring of the production process.
Only the manufacturer or its authorised representative registered in the EAEU may draw up a conformity declaration when Module 5D is used.
This is the only conformity assessment module used in the EAEU that requires expert assessment of production facilities. This assessment means that a quality management certificate must be obtained by the manufacturer. Module 6D is intended for mass-produced finished products that have or are intended to have numerous modifications. The list of conformity assessment measures includes:
- sample testing by a special EAEU-accredited laboratory;
- quality management system certification;
- the manufacturer must perform regular self-monitoring of the production process.
Only the manufacturer or its authorised representative registered in the EAEU may be the declaration applicant when this module is used.
It is worth noting that all modules require submission of a standard document package. The package includes technical documentation for the product and extracts from registers containing information about the applicant. Also, if module 1D or 2D is used, the applicant is required to submit proofs of product conformity.
A DoC for single product units or a batch of products is issued for the duration of the product’s lifetime or for an indefinite period. A DoC for mass-produced goods is issued for a period not exceeding five years. ADoCmaybesuspendedincertaincases.