Assessment (confirmation) of conformity of industrial products. Preparing a technical file

WHO NEEDS?

Currently, in Ukraine, there is increasing the responsibility of market operators for sale of industrial products that pose a danger or risk to consumers or that do not meet the requirements established in technical regulations.

So, Ukrainian legislation obliges the market operators to:

- ensure the compliance of the goods with safety requirements in the national market;

- to prevent ingress of the products that pose a serious risk to the Ukrainian market;

- apply restrictive (corrective) measures in relation to the goods that pose a threat or are non-compliant with safety requirements.

Industrial
product
manufacturer

Importer
to Ukraine

Exporter
to EU

Distributor
in Ukrainian
market

COMPANIES SHALL:

Bring the products in compliance with the regulatory legal documents and safety requirements of Ukraine and / or the EU, as well as prepare the Technical File.

WHAT CATEGORIES OF GOODS ARE SUBJECT TO THE NEW REQUIREMENTS:

Machines

Elevators

Electromagnetic compatibility

Simple pressure vessels

Pressure equipment

Gas-fired devices

Measuring instruments

Marine equipment

Medical devices

Toy safety

Pleasure boats

Packaging and wastes

Specification of marking and standard information on the consumption of energy and other resources related to energy products

Electrical equipment designed for certain voltage limit values (low voltage equipment)

Requirements for efficiency of new water-heating boilers operating on liquid or gaseous fuels

Technical requirements for energy consumption of electric household refrigerators and freezers

Mobile pressure equipment

Non-automatic weighing instruments

Individual protection means

Active implantable medical devices

Protection equipment and systems designed for use in explosive media

Radio- and telecommunications terminal equipment and mutual recognition of their compliance

Construction products, including measures for their implementation

In vitro diagnostic medical devices

Rope systems for transporting people

High speed railways

Civil explosives

DIDN'T YOU FIND YOUR CATEGORY IN THE LIST?

Each of the above 27 groups includes a considerable set of industrial products. If you have not found your products, we will help you to determine the group or groups that your products fall into.

WHAT IS THE TECHNICAL FILE AND WHY IT SHALL BE PREPARED BY EXPERTS

In order to prove that the product meets the safety requirements, the manufacturer shall prepare the Technical File.

The Technical File is documentation that contains a description of the product; terms of reference, drawings and diagrams of the product; descriptions and explanations necessary for understanding drawings and diagrams, as well as product operation; a list of harmonized standards applied, in whole or in part, to this product; product safety / risk assessment, results of design calculations and tests performed; test reports, etc. to confirm the compliance of the goods with the safety requirements.

WE GUARANTEE:

Correct identification of the regulatory legal documents and essential safety requirements applicable for your products

Saving at least 50% of time, in comparison with the preparation of technical documentation by yourselves

Avoidance of fines on the part of the market supervision authority

Forming a working group at the enterprise responsible for the control of the Technical File subsequently

you'll obtain

Draft Technical File that proves your product compliance

Standard form of Declaration of Conformity

Particular plan of actions to complete the process of product compliance proving

Trained team at your enterprise

4 STEPS TO PROVE PRODUCT COMPLIANCE:

STEP 1:

Identification of the valid regulatory and legal documents and essential safety requirements that apply to the products.

As a result, you get:

A clear understanding of all safety requirements that the product shall comply with.

STEP 2:

Assessment of the goods for conformity to essential requirements, assessment of the risks of products in relation to the consumer and determining their degrees.

As a result, you get:

A list of risks posed by the product, and the plan of actions in relation to requirements with an undetermined level of risk.

STEP 3:

Determination of available procedures for assessing the conformity of the products, reduction of the maximum number of risks, conducting conformity assessment.

As a result, you get:

Proof that the essential requirements that apply to the product have been met through the tests carried out.

STEP 4:

Preparation of technical documentation (Technical File) with all information necessary to prove the compliance of the product, issue of the Declaration of Conformity and application of the conformity mark.

As a result, you get:

Tthe Prepared documentation, which is the proof of the product conformity to the safety requirements, the Technical File, as well as the Declaration of Conformity and the mark of conformity.

FREQUENTLY ASKED QUESTIONS

Do I need to prove product conformity if I work in the domestic market and do not plan to export products?

The manufacturer is obliged to introduce into circulation only safe products, regardless of whether he will export them or not in accordance with the provision of the Law of Ukraine "On the general safety of non-food products." The technical file is just the proof that the product meets the safety requirements.

What are the obligations of the manufacturer when releasing products to the domestic market?

First of all, you, as a manufacturer, are obliged to: - Put into circulation only safe products; - Conduct product testing; - Consider consumer petitions and take measures to reduce the risk associated with the consumption and operation of the product; - Provide the consumer with detailed information so that the consumer is able to assess the risks associated with the product; - Cooperate with the government market supervisors on risk prevention measures.

ДолженDo I, as a manufacturer, have to make up the Declaration of Conformity and apply the conformity mark? Or is it the competence of a certain body?

In the cases specified in the technical regulations that provide for application of the conformity assessment procedures, the manufacturer or his authorized representative shall make up the declaration of conformity. The conformity mark shall also be applied only by the manufacturer or his authorized representative.

If there is no separate regulation for my product, does this mean that there exist no requirements for its safety?

Even if you have not found a separate regulation, this does not mean at all that there are no safety requirements for your product. The provisions of the Law of Ukraine "On general safety of non-food products" apply to such products».

INDUSTRIAL PRODUCT CONFORMITY ASSESSMENT AND TECHNICAL FILE PREPARATION

WHO NEEDS?

FIND OUT IN WHAT DEGREE YOU ARE READY FOR NEW REQUIREMENTS

WHAT IS THE TECHNICAL FILE AND WHY IT SHALL BE PREPARED BY EXPERTS

4 STEPS TO PROVE PRODUCT COMPLIANCE: