A Technical File – often referred as Technical Documentation – is required for all products falling under the medical devices legislation, including low risk class I medical devices, low risk in vitro diagnostic (IVD) medical devices and custom made devices.
mdi Europa will help you to comply with the necessary legislation and assist in ensuring that your Technical File is ready for review by a Notified Body (as and when necessary) or the local competent authorities in Europe.
Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) requirements on Technical Files
Under the MDR (EU) 2017/745 and IVDR (EU) 2017/746, requirements have been expanded and substantiated:
- Device description and specifications including variants and accessories
- Information to be supplied by the manufacturer
- Design and manufacturing information
- General Safety and Performance Requirements
- Benefit-risk analysis and risk management
- Product verification and validation
In addition, a separate annex III has been dedicated to Post-Market Surveillance (PMS) requirements for the Technical Documentation.
mdi Europa set up a checklist and template to assist manufacturers in the compilation of their Technical Files. You may find these and corresponding information, using the links below. You are also invited to make use of our extensive expert network should you require in-depth support. Please get in touch for further information!