Directive 2006/42/EC Machinery (MD)
When wishing to export Ukrainian-made machines and mechanisms, a Ukrainian manufacturer must take into account the fact that in the European Union countries special requirements are imposed on some product categories. According to Directive 2006/42/EU on the safety of machinery, one of such requirements is product certification with CE marking.
About Directive 2006/42/EC
Directive 2006/42/EC on machinery and equipment of May 17, 2006, adopted in order to minimize the risks to life and health of people, the environment during the operation of machinery and equipment. As well as reducing losses and costs for eliminating the consequences of poor-quality equipment or its misuse.
Directive 2006/42/EC, which replaced Directive 98/37/EC, establishes harmonized safety standards for machinery and equipment that must be followed by manufacturers, importers and distributors to gain access to the markets of the specified products in the European Union, Turkey and Switzerland. At the same time, it must be implemented within the framework of national legislation.
The purpose of the Directive is to determine the safety requirements for machinery and equipment relating to their design, control, transportation and installation, the materials from which they are made, etc.
Scope
The scope of Directive 2006/42/EC covers parts and mechanisms that are interconnected to perform certain functions, are equipped with a drive and at least one of the elements of which is movable.
Potentially, any machinery and mechanisms can be included in the scope of Directive 2006/42/EC on machinery and mechanisms.
Directive 2006/42/EC applies to the following products:
- machines and mechanisms;
- interchangeable equipment;
- safety components;
- lifting appliances;
- chains, ropes and nets;
- removable mechanical transmission devices;
- partly completed machines and mechanisms.
Directive 2006/42/EC does not apply to:
- spare safe components of machines;
- amusement park equipment;
- machines and mechanisms for nuclear power;
- weapons, military and police equipment;
- vehicles, aircraft, sea vessels;
- devices designed for scientific purposes;
- rope lifts in mines;
- electrical equipment for household and office use, as well as electric motors;
- high-voltage equipment and transformers.
Requirements of Directive 2006/42/EC
Before placing machinery and equipment on the market or putting them into service, the manufacturer or his authorized representative must:
- ensure that machinery and mechanisms meet safety requirements;
- ensure the availability of technical documentation;
- carry out the conformity assessment procedure;
- draw up a declaration of conformity in accordance with Annex II of Directive 2006/42/EC;
- affix the CE marking.
For machines and mechanisms, depending on their degree of danger, different conformity assessment modules can be applied. With or without the involvement of a notified certification body. Mandatory involvement of an EU notified body for the conformity assessment is required for machines and mechanisms listed in Annex IV of Directive 2006/42/EC.
Technical documentation
To confirm the compliance of machinery and equipment with Directive 2006/42/EC, the manufacturer or authorized representative must have technical documentation.
The technical documentation must include the following:
- description of machines and mechanisms;
- drawings and diagrams of machines and mechanisms;
- risk assessment documentation;
- health and safety requirements;
- laboratory test results;
- instructions;
- EU declarations of conformity.
Rules and conditions of application CE marking
Machines and mechanisms that have passed the conformity assessment procedure are subject to CE marking.
The marking is applied to each product sample in such a way that it is clearly visible, clear and indelible.
If the marking cannot be applied to machines and mechanisms, it is applied to the accompanying documentation or packaging.
CE marking must be affixed in close proximity to the name of the manufacturer or his authorized representative.
Other information must also be marked on the product, which may vary depending on the requirements of the specific standards applied to the product. However, the following information must be indicated: manufacturer's name, brand, country of manufacture, contact address and telephone number of the manufacturer, its contact center or its representative, CE mark. It is important that this information corresponds to that indicated in the declaration of conformity.
Our services
Our specialists have many years of experience in the field of certification and issuing European certificates. We have solutions for most of the tasks that arise in the certification process.
Using an individual approach to each client, we will select the best option for you, taking into account the specifics of your enterprise. In order for the procedure for obtaining a European certificate to go according to plan and within the desired time frame, our specialists will conduct detailed consultations and provide answers to all questions of interest.
We provide the following certification services:
- consultation on all issues related to product certification;
- selection of the relevant standard(s) for your product;
- assistance in compiling a technical file for the products being manufactured;
- conclusion of an agreement for an authorized representative of your company in the EU, if necessary;
- testing of products of any complexity in testing laboratories in Ukraine and Europe;
- verification and assistance in creating a factory control system;
- support in auditing your production by auditors of the European certification body;
- preparation of a declaration of conformity;
- full support of the procedure for obtaining CE certification with the issuance of certificates.
Working with us, you communicate directly with professionals of the European level. This ensures the fastest possible issuance of the certificate, without overpayment for mediation.
The cost of our services is determined individually depending on the specifics of the product, the terms required to obtain the certificate, and the documentation available to the customer.