![]() ![]() What Information Should Be Included in a Technical File?Īt a minimum, the technical file should include the following elements per EU MDR Annex II: ![]() Arguably more important than the structure itself, the technical file must always be up-to-date and reflect any changes or modifications to the product. There are no documented requirements for the exact structure or format of the technical file however, information should be presented in a manner that allows any reviewers to clearly see and understand its contents. How Should We Structure a Technical File? Best practice is the manufacturer (or their authorized representative) maintains the technical file for at least 10 years from the last date of manufacture of the product. This documentation must be available for the appropriate authorities to review it upon request. ![]() This technical documentation, organized in a technical file (TF), provides evidence that a medical device meets the general safety and performance requirements and conforms to CE-marking legislation. ![]() If you’re like a lot of med device companies we work with, you may be asking what a technical file is, how it should be formatted, and what needs to be included?įor companies intending to sell product in the European Union, technical documentation is required per EU MDR in order to CE mark product. European regulations require manufacturers to create and maintain a technical file as a prerequisite to submitting a Declaration of Conformity, allowing products to be CE marked. ![]()
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