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 specialise 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.
We can offer
- Reviews and assistance with compilation of technical files
- Draft Declarations of Conformity
- Self certification packs
Other relevant products and services we offer:
Does it apply to you?
Yes, if CE marking applies to your product then in most cases you will be obliged to create a technical file and sign a declaration of conformity.