Technical File Content of Medical Devices
The technical file content of medical devices should include all of the above: raw materials, labels, and shelf life and storage conditions (Answer: D). 1
Comprehensive Technical Documentation Requirements
Medical device technical files must contain extensive documentation to demonstrate conformance with essential requirements and ensure safe interoperability. The manufacturer must specify the intended purpose, technical specifications, and indications and limits of use for its product, all of which must be supported by clinical evidence and documented in the instructions for users and technical documentation. 1
Core Components of Technical Files
Raw Materials Documentation:
- Complete specifications of all materials used in device construction must be documented, including their origin, structure, and manufacturing process controls 1
- Control of materials and critical steps in the manufacturing process must be thoroughly detailed 1
- Composition and impurities of all materials require full documentation 1
Labeling Requirements:
- Labels must display Unique Device Identifiers (UDIs) that catalog goods by manufacturer, make, model, serial number, lot number, expiration date, and manufacturing date 1
- All labeling information must be unambiguous and clearly identify the device without possibility of misidentification 1
- Instructions for users must be comprehensive and included in the technical documentation 1
Shelf Life and Storage Conditions:
- Stability data under both long-term and accelerated storage conditions must be provided 1
- Container closure system specifications must be documented 1
- Storage temperature ranges, humidity requirements, and environmental conditions must be clearly specified 1
Additional Essential Technical File Elements
Quality Control and Specifications:
- Full control specifications, analytical procedures, validation of analytical procedures, batch analyses, and justification of specifications must be included 1
- Release specifications of the product and implementation of the full set of characterization assays must be prepared 1
- All assays must be verified or qualified before GMP manufacturing 1
Manufacturing and Sterilization:
- Robust manufacturing process documentation is required, including sterilization methods 1
- For devices around or larger than 200 nm, aseptic manufacturing methods must be implemented and documented 1
- Containers, closures, and packaging material quality and compatibility with the product must be ensured 1
Regulatory Compliance:
- Technical documentation must demonstrate conformance with essential requirements at the product or system level, taking into account system components and interactions used to achieve the intended purpose 1
- Independent notified bodies conforming with EU MDR evaluate and approve medical devices based on this technical documentation 1