Technical File Requirements
 

What is a technical file?

 

A technical file is a summary document prepared by the manufacturer in a clear, well-organized, readily searchable, and unambiguous manner to demonstrate the safety and performance of the specific piece of equipment Regardless of its intended use, design, or even the safety history of the equipment, the manufacturer must have – and keep up-to-date – this technical documentation, in order to demonstrate the compliance with general safety and performance requirements of the legislation

 

The Economic Operator (manufacturer or the manufacturer's authorised representative) must be available to provide the technical file for inspection to the national market surveillance authorities as soon as the product is placed on the market, whatever its geographical origin is. Sometimes, the documentation may also need to be submitted to a Notified Body for storage or review.

 

What does the average technical file include?

 

• Product description and specification, including all the variants and accessories;

• Markings

• Instructions for use in all the languages accepted in the Member States where the product is foreseen to be sold;

• Design and manufacturing information, such as design schematics, and mechanical assembly drawings;

• Documentation demonstrating compliance with all general safety and performance requirements and all relevant standards; {usually in  the form of a clause-by-clause assessment against each top-level standard}

• Risk analysis file;

• Product verification and validation report, and other relevant documentation;

• Declaration of Conformity

 

If you have an existing technical file and you have some doubts try our technical file review services. Alternatively, if you’re entering the EU or the UK for the first time or don’t know where to start, getting our help utilising our consultants, gives you valuable real-world insights into regulatory compliance. As a result, you can trust us to provide a higher quality, technical construction file which demonstrates compliance with the applicable requirements