The technical documentation requirements for CE marking depend on the nature of the product and the applicable European directives (e.g., Medical Device Regulation (MDR) or Medical Device Diagnostic Performance Regulation (IVDR)). However, in general, technical documents usually need to include information on:
Product Description: Provide a detailed product description, including the design, function, use, specifications and other information of the Brain Loop Tracker.
Technical Specifications: Includes the technical specifications of the device, such as size, weight, power requirements, etc.
Manufacturing Process: Describe the manufacturing process of the product, including the production process, key steps, raw material selection, etc.
Quality Control: Provide a quality management system, including quality control measures and test methods in the production process.
Performance Testing: Includes performance test data for equipment to ensure that it meets design specifications and relevant technical standards.
Safety and efficacy evaluation: Provide safety and efficacy evaluation of products, including clinical trial data, biocompatibility testing, etc.
Instruction Manual: Provide clear and detailed instruction manuals to ensure that the operator uses the Brain Loop Tracker correctly.
Labelling and marking: Provide product labelling and identification designs to ensure compliance with the requirements of European directives.
Registrant Manufacturer Information: Provide relevant information about the registrant or manufacturer, including registration certificate, production license, etc.
Regulatory compliance: Demonstrate compliance with relevant European regulations and standards, including medical device regulations.
Risk Analysis: Conduct a risk analysis of the product and provide corresponding control measures.
Adverse Events and Recall Plans: Provides information about adverse events and recall plans.