If you have an existing technical file and some familiarity with the EU essential safety & health requirements, our technical file review services may fit the bill.
The manufacturer is expected to periodically review and update the Technical File, and all changes must be recorded.Īs part of the CE Marking process, it is also advised that an external expert reviews the Technical File. Adding files to your TeXnicle project is a. TeXnicle lets you manage your project by providing you with a simple tree view of your project.
Manufacturers based outside the EEA are to make it available at the address of their European Authorized Representative. Download Latest Version for Mac (17.39 MB) TeXnicle is a LaTeX editor and project organiser for OS X with a feature-rich interface to help you manage your LaTeX projects. 'TeXnicle is free (as in beer) and will remain so. it can handle almost any encoding, so it should be of special interest to anyone producing documents in languages with heavily accented alphabets.
EU and National Authorities, Notified Bodies, and Authorized Representatives).Īn up-to-date electronic or hard copy of the file needs to be kept available in Europe, allowing it to be presented to any EU Competent Authorities upon request. TeXnicle is capable of using a variety of TeX engines, e.g., pdf(La)TeX, Lua(La)TeX, Xe(La)TeX, etc. however, English is the most commonly used, since it allows the document to be easily understandable by anyone who has to revise it (e.g. TeXnicle overview TeXnicle is a LaTeX editor and project organiser for OS X with a feature-rich interface to help you manage your LaTeX projects. The technical documentation for a compliant MDR or IVDR device must follow Annex II and III of the MDR or IVDR, as applicable, and they must hold essential information about the medical device, including photographs and diagrams.Ī Technical File can be compiled in any of the official languages of the EU Nevertheless, the national authority might request a part of the file to be translated. Do not use the Protective Sheets on wet or hot surfaces, or near a heat source. It is required for all classes of medical devices – Class I, Is, Irsi, Im, IIa, IIb, III as well as all in vitro diagnostic medical devices – and must be created by manufacturers before having the CE Marking affixed on their product(s). For your safety, follow these precautions when using the. A Technical file (also referred to as Technical Documentation or TF) is a document proving that a medical device is compliant with the essential safety and health requirements set down by the relevant Directive or Regulation.