An essential part of CE-marking a product involves compiling a Technical File and signing a Declaration of Conformity. This may seem daunting at first, but we have extensive experience in this area and can assist with a wide variety of tasks.
Declarations of Conformity are essentially a legal statement from the company responsible for CE-marking, stating that they have completed all of the compliance procedures. It should list the applicable directives and standards, provide a description of the product and the details of the person taking responsibility for it. More information can be found on our Declarations webpage. Since it was founded, Conformance Ltd. has produced draft Declarations for our customers to complete and sign. We specialize in both generating Declarations for new products and reviewing and updating existing Declarations, the only thing we can’t do is sign it for you.
A Technical File is your collection of evidence that you have done everything required to CE-mark your products. Typically, this consists of technical drawings, parts lists, assessment checklists and results, the instruction manual and signed Declaration. The various directives contain additional requirements. However, the File can contain any information relevant to your product and its safety; the directives only list the mandatory contents. Over the years, Conformance Ltd has helped a wide variety of companies in compiling and maintaining their Technical Files. From providing a list of recommended contents, through reviewing existing files and providing feedback, to collating information on a customer’s behalf, we can find the solution that’s right for you.
Declaration of Conformity
The Declaration of Conformity is a legal Document which must accompany all CE Marked products sold in the European Union. Almost all new products must be supplied to the end user with a Declaration of Conformity. This document needs to include the following:
- Name and address of organization taking responsibility for the product
- Description of product
- A list of the applicable safety directives the product complies with
- Details of relevant standards may be included.
- The manufacturer or a representation of the organization placing the product on the market should then sign the Declaration.
Conformance has assisted thousands of companies through the CE marking process and helped them produce a Declaration of Conformity to accompany their products.
Technical File Information
All CE marking directives require the manufacturer of the product to create a technical file which should contain the information required to show that the product properly complies with the requirements of the directives which apply to it.
The directives contain clauses which give some general details of the kind of information which will be required in the technical file, but this is couched in the most general of terms. As a general guide, the following items should be included:
- Description of the apparatus, usually accompanied by block diagram
- Wiring and circuit diagrams
- General Arrangement drawing
- List of standards applied
- Records of risk assessments and assessments to standards
- Description of control philosophy/logic
- Datasheets for critical sub-assemblies
- Part list
- Copies of any markings and labels
- Copy of instructions (user, maintenance, installation)
- Test reports
- Quality control & commissioning procedures