The EC declaration of conformity means that the product or device complies with regulations and standards. It is a written statement by the manufacturer/operator stating that the product meets the requirements of the technical regulations in force in the EU (i.e. also the Czech Republic) and that the established procedure for conformity assessment was followed.

The procedure for assessing compliance is set by Act 22/1997 Coll. as amended and Government Regulation No. 176/2008 Coll., which corresponds to Directive 2006/42/EC of the European Parliament and of the Council on machinery.

Which machinery must have an EC declaration of conformity and a CE label according to 2006/42/EC?

1. all machinery manufactured after 1997, i.e. after the introduction of Act 22/1997 Coll.
2. machinery manufactured before 1997, for which there was a substantial change, viz. see the manual for the application of Directive 2006/42/EC, § 72, paragraph 4
3. machinery imported from countries outside the EU

When is it necessary to meet the requirement for an EC declaration of conformity for machinery?

• before the product or device is placed on the market, a written EC declaration of conformity must be issued and the product must be marked with the CE mark

What precedes the issuance of the EC Declaration of Conformity?

By issuing an EC declaration of conformity, it is declared that the entire machinery, from its design, construction, electrical connection and more, is in accordance with the currently valid standards and regulations. A risk assessment was also carried out, according to which all risk measures that were identified were taken. This means that you have added safety features or other proposed measures.

Therefore, if all the requirements of the engineering directive 2006/42/EC are met, the technical documentation according to Annex VII is complete, it is possible to issue an EC declaration of conformity on the device and mark the device with a production label with the CE symbol.

What is the output of issuing an EC risk declaration?

• final reports according to 2006/42/EC, annex VII, part A, paragraph 1
• separate EC declaration of conformity according to 2006/42/EC, Annex II

What are the minimum documents we need to provide for the request?  

• facility name
• description of device function, description of control
• photo or video function of the device (view photos from all sides)
• relevant diagrams - electrical, pneumatic, etc.
• prepared risk assessment

If these documents do not exist, we will consult on the next procedure and their creation for subsequent cooperation.

How long does the whole process take?

The deadline is determined based on the current workload of our team, then the content of the technical documentation and possibly other documents necessary for the preparation of the documents. By default, the issuance of the EC declaration of conformity is a matter of a few days. Everything is, of course, conditional on the cooperation of the customer and the delivery of documents.

How do you get started when you need an EC declaration of conformity and a CE issue for machinery?