Technical File Services
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. 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).
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.
A 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. 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. EU and National Authorities, Notified Bodies, and Authorized Representatives).
An 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. Manufacturers based outside the EEA are to make it available at the address of their European Authorized Representative.
The manufacturer is expected to periodically review and update the Technical File, and all changes must be recorded.
As part of the CE Marking process, it is also advised that an external expert reviews the Technical File.
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. Alternatively, if you're entering the EU for the first time or don't know where to start with, getting our help with a technical file creation as part of our consultancy services may be what you are looking for.
Interested in getting a quote of our technical file services?Get in touch