Your product technical construction files are the centre of your product CE declarations and marking. These files are essential to demonstrate compliance and can be requested by various bodies including Trading standards, HSE, and the National Measurement Office if there is a complaint about your product or for market surveillance under the New Approach Directives. If an enforcement body finds your product doesn’t meet the CE marking requirements the best case is that you may have opportunity to correct this although you may have to take the product off the market and face a potential product recall, a fine or imprisonment.
If you are a manufacturer it is your responsibility to:
- carry out the conformity assessment
- set up and maintain the technical file
- issue the EC Declaration of Conformity (DoC)
- place CE marking on a product
Distributors must check the presence of both the CE marking and the necessary supporting documentation.
UK government guidance on CE marking can be found here
How we can help
We have substantial experience of achieving and maintaining compliance for radio based electronics products including mains powered equipment which are within the the scope of the Radio Equipment Directive, EMC directive, and Low Voltage Directives as well as Fire Products which are within the Construction Products Regulation and require the involvement of a Notified Body and have increased test, and documentation and change control requirements.
We can help you to understand the requirements of the directives, ensure you have sufficient test evidence for each part of the directives, most usually through the application of product standards and collate the technical construction file identifying any gaps which need to be filled. An important part of the process is undertaking whole of life risk assessments covering dispatch, installation, service, maintenance, intended uses, reasonably foreseeable misuse’s and disposal.
After the file is produced it must be regularly reviewed and updated for changes to the product e.g. component change, firmware update and modification and also for changes to standards and directives used to demonstrate and evidence compliance. Best practise is to review technical files every 6 to 12 months.
Our Technical Construction File Assembly and Maintenance Service takes the headache out of this ongoing maintenance overhead and leaves you free to grow your business and develop new products with the confidence that your CE mark meets and continues to meet the necessary requirements.