Section 1: Device description and specifications including variants and accessories

· Intended purpose

· Devices covered by the Technical Documentation

· Classification

· Device description and specification

The device description should enable understanding of the design, composition and presentation or other characteristics of the device and should include product or trade name. A general description of the device including its intended purpose and intended users should also be provided.

· Reference to previous and similar generations of the device

Section 2: Information supplied by the manufacturer

· Labels and instructions for use

Section 3: Design and manufacturing information

· Materials and components

· System overview

· Manufacturing information

· Sites involved in design and manufacturing activities

Section 4: General safety and performance requirements (GSPRs)

· Demonstration of conformity with GSPRs

· Product and design specifications

· Chemical, physical and biological properties

· Devices intended to be connected to other devices to operate as intended

· Devices with a measuring function

· Protection against radiation

· Software

· Electrical safety and electromagnetic compatibility

· Protection against mechanical and thermal risks

Section 5: Benefit-risk analysis and risk management

· Risk management

Section 6: Product verification and validation

l Specimen type

l Performance evaluation and clinical evidence

This should include studies to demonstrate:

? Analytical sensitivity,

? Analytical specificity,

? Trueness (bias),

? Precision (repeatability and reproducibility),

? Accuracy (analytical and clinical),

? Limits of detection and quantitation,

? Linearity,

? Assay cut-off,

? Sample handling

? Interfering substances (endogenous and exogenous),

? Cross-reactivity.

l Post-market surveillance and post-market performance follow-up

l Product verification by EURL

Section 7: Stability

l Stability including shelf-life

l Packaging and transit verification

l Sterilisation

l Declaration of conformity

l Additional information required in specific cases

l Companion Diagnostics