CE MARK TECHNICAL FILE 2025

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The CE marking procedure is one of self-certification. Generally, you can do everything yourself and the steps below will guide you through the process. The UKCA and CE marking process requires a detailed knowledge of the directives and standards relevant to your product.
A Technical File on the other hand goes above and beyond a DHF. A technical file in a lot of ways is a DHF but emphasizes your devices safety, performance, and adherence to regulatory requirements for the European Union.
The medical device technical file (now known simply as the medical device file) is a term used in ISO 13485:2016. It refers to the documents required by auditors and regulators to prove your product currently meets all performance and safety standards.
The UL mark is often considered to be the equivalent of the marking that is known in the European Union as the CE marking.
Compliance in the United States of America (USA) Unlike the CE marking system, for the USA an approval marking is required, which may vary. An approval marking commonly know is the UL approval mark, which is given by UL after a successful evaluation by UL acting as an NRTL (Nationally Recognized Testing Laboratory).
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The technical documentation is necessary to prove the product meets the essential requirements and therefore justify and support an EU declaration of conformity. You need this documentation in order to affix the CE marking to the product.
The technical file includes the device description and specification, the basic unique device identifier (UDI), the principles of operation and its mode of action, label and packaging information, instructions for use (IFU) in the languages where the device will be sold, design and manufacturing information, the
However, the CE mark does not apply in the United States, and electronic devices that have received CE certification cannot legally enter the United States market without also passing testing for US electrical compliance regulations. The United States has its own regulatory framework for electronic devices.
The technical documentation provides information on the design, manufacture, and operation of a product and must contain all the details necessary to demonstrate the product conforms to the applicable requirements.

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