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. 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?
What is a Technical File?
For companies intending to sell product in the European Union, technical documentation is required per EU MDR in order to CE mark product. 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. This documentation must be available for the appropriate authorities to review it upon request. 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.
How Should We Structure a Technical File?
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. 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.
What Information Should Be Included in a Technical File?
At a minimum, the technical file should include the following elements per EU MDR Annex II:
- A general device description and specifications: This includes but is not limited to its intended use and target patient population, device classification and rule rationale, UDI-DI information, description of accessories and variants, and principles of operation and key functional elements
- A complete set of label(s) on the device and its packaging and instructions for use: Instructions should be in the appropriate languages
- Detailed design and manufacturing information: This includes manufacturing processes and their validation, final testing data, and identification of all sites, suppliers, and/or subcontractors where design and manufacturing is performed
- General safety and performance requirements (GSPR): This information demonstrates conformity with the GSPRs per Annex I and includes justification of information that meets those requirements as well as any harmonized standards applied
- Documented risk management and risk-benefit analysis information
- Product verification and validation and post-market surveillance information: This includes pre-clinical and clinical data such as study protocols and test results, a clinical evaluation plan and report, and a PMCF or justification for no PMCF
At Rook Quality Systems, our team of expert Quality Engineers has extensive experience organizing, preparing, and reviewing technical documentation. We have assisted numerous clients in keeping this documentation up-to-date, and living in a manner that conforms to the regulation and is accepted by reviewers.
To have your technical file reviewed prior to submitting to a Notified Body, or for more hands-on help in the development of this file, look no further than Rook; we’re here to help.