Device Description

(a) Product or Trade Name and General Description: Begin by introducing the device, including its name and a brief overview of its purpose. Consider highlighting its key features and functionalities to provide context to the reader.

(b) Basic UDI-DI or Clear Identification: Include the Basic Unique Device Identification-DI or any other clear identifier assigned by the manufacturer. This ensures traceability and facilitates proper documentation.

(c) Intended Purpose: Detail the device’s intended purpose, covering aspects such as what it detects/measures, its function (e.g., screening, monitoring), specific disorders or conditions it addresses, automation level, type of specimens required, testing population, and intended users. For companion diagnostics, mention the target population and associated medicinal products.

(d) Principle of Assay Method or Operation: Describe the underlying principle behind the device’s assay method or operation. This provides insights into its functionality and helps users understand its working mechanism.

(e) Rationale for Device Qualification: Explain why the product qualifies as a medical device. This could include its intended medical use, diagnostic capabilities, or therapeutic benefits.

(f) Risk Class and Justification: Specify the risk class of the device as per regulatory standards and justify the classification rule(s) applied, referring to Annex VIII for guidance.

(g) Components and Reactive Ingredients: Provide a detailed description of the device’s components, including any reactive ingredients in relevant components like antibodies or nucleic acid primers. This enhances transparency and facilitates proper handling.

(h) Specimen Collection and Transport Materials: If applicable, describe the specimen collection and transport materials provided with the device or recommended specifications for use. This ensures proper sample handling and processing.

(i) Instrumentation Characteristics: For instruments of automated assays, outline the appropriate assay characteristics or dedicated assays. This helps users understand the device’s capabilities and limitations.

(j) Software Description: If the device utilizes software, describe its functionality and compatibility. Include any relevant information on software versions, updates, and user interfaces.

(k) Configurations/Variants: List and describe various configurations or variants of the device intended for the market. This helps users choose the most suitable option for their specific needs.

(l) Accessories: Provide a comprehensive list and description of accessories intended for use with the device. This ensures users have all necessary components for optimal performance

1.2. Reference to Previous and Similar Generations of the Device

(a) Overview of Previous Generations: Describe any previous iterations of the device manufactured by the company, highlighting key improvements and changes over time.

(b) Overview of Similar Devices: Provide an overview of similar devices available in the Union or international markets, including comparative analysis where applicable.

2. Information Supplied by the Manufacturer

(a) Labeling: Manufacturers must provide labels for the device and its packaging, including single unit, sales, and transport packaging. These labels must be in languages accepted in the Member States where the device will be sold.

(b) Instructions for Use: Manufacturers must supply instructions for use in languages accepted in the Member States where the device will be sold.

3. Design Information

(a) Description of Critical Ingredients: Provide a detailed description of critical components of the device such as antibodies, antigens, enzymes, and nucleic acid primers, along with recommendations for their use.

(b) Instrument Description: For instruments, outline major subsystems, analytical technologies, control mechanisms, and dedicated computer hardware and software.

(c) System Overview: Provide an overview of the entire system for both instruments and software to facilitate understanding of their functionalities.

(d) Software Algorithm Description: Describe the data interpretation methodology, specifically the algorithm used in the software.

(e) Self-testing or Near-patient Testing Design Description: Detail design aspects that make devices suitable for self-testing or near-patient testing.

3.2. Manufacturing Information

(a) Manufacturing Process Description: Provide information on production, assembly, final product testing, and packaging processes to ensure understanding. Detailed information should be available for quality management system audits and conformity assessment procedures.

(b) Site Identification: Identify all sites, including suppliers and subcontractors, involved in manufacturing activities. This ensures transparency and accountability throughout the manufacturing process.

4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

Documentation Requirements for Conformity with General Safety and Performance Requirements:

Identification of Applicable Requirements: The documentation must clearly identify the general safety and performance requirements set out in Annex I that are applicable to the device based on its intended purpose.

Justification for Non-Applicable Requirements: If any general safety and performance requirements are deemed not applicable to the device, the documentation must provide a clear justification for their exclusion.

Methods Used for Conformity Demonstration: Outline the methods employed to demonstrate conformity with the identified general safety and performance requirements. This may include testing, analysis, risk assessment, or other appropriate methods.

Harmonized Standards or Common Specifications (CS): Where applicable, reference harmonized standards or Common Specifications (CS) utilized in demonstrating conformity. These standards should align with the relevant regulatory requirements.

Cross-Reference to Supporting Evidence: Provide cross-references to the location of evidence within the full technical documentation that demonstrates conformity with the identified general safety and performance requirements. This ensures that regulators and other stakeholders can easily locate and review the supporting documentation.

5.BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT

Documentation Requirements for Benefit-Risk Analysis and Risk Management:

Benefit-Risk Analysis (Annex I, Sections 1 and 8): Provide information on the benefit-risk analysis conducted for the device. This analysis should assess the benefits and risks associated with the device’s use, considering factors such as intended purpose, patient population, and potential clinical outcomes.

Risk Management (Annex I, Section 3): Detail the solutions adopted and the results of the risk management process. This includes identifying hazards, assessing risks, implementing risk controls, and monitoring the effectiveness of those controls. The documentation should demonstrate how risks are mitigated to ensure the safety and performance of the device.

6. Product Verification and Validation

The documentation must include the results and critical analyses of all verification and validation tests/studies to demonstrate the device’s conformity with Regulation requirements, especially the general safety and performance requirements. This encompasses:

6.1. Information on Analytical Performance of the Device:

6.1.1. Specimen Type: Describe the different specimen types analyzed, including stability during storage and transport conditions. Include information on the timeframe between specimen collection and analysis, as well as storage conditions like duration, temperature limits, and freeze/thaw cycles.

6.1.2. Analytical Performance Characteristics:

6.1.2.1. Accuracy of Measurement: (a) Trueness: Provide information on the accuracy of the measurement procedure, including data to assess trueness. This applies to both quantitative and qualitative assays when certified reference materials or methods are available. (b) Precision: Describe repeatability and reproducibility studies.

6.1.2.2. Analytical Sensitivity: Include details about the study design and results, describing specimen type and preparation, analyte levels, and replication. Explain how assay sensitivity was calculated.

6.1.2.3. Analytical Specificity: Describe interference and cross-reactivity studies to determine analytical specificity in the presence of other substances in the specimen. Include evaluation of potentially interfering substances, their concentration, specimen type, analyte test concentration, and results.

6.1.2.4. Metrological Traceability: Provide information on the metrological traceability of calibrator and control material values.

6.1.2.5. Measuring Range: Describe the measuring range, including the limit of detection, regardless of linearity. Explain how the range and detection limit were established, including specimen type, replicates, and specimen preparation. Include any mitigation steps for high-dose hook effects.

6.1.2.6. Assay Cut-off: Summarize analytical data and study design for determining the assay cut-off. Include population demographics, specimen characterization methods, and statistical analysis methods like Receiver Operator Characteristic (ROC). If applicable, define grey/equivocal zones.

6.1.3. Analytical Performance Report (Annex XIII): Include the analytical performance report as outlined in Annex XIII of the Regulation. This report summarizes the device’s analytical performance characteristics, helping demonstrate its conformity with regulatory requirements.

6.2. Information on Clinical Performance and Clinical Evidence: Performance Evaluation Report

The documentation must contain a performance evaluation report, including reports on scientific validity, analytical performance, and clinical performance, as outlined in Annex XIII. Additionally, an assessment of these reports should be provided. Clinical performance study documents referenced in Section 2 of Part A of Annex XIII must be included or fully referenced in the technical documentation.

6.3. Stability (Excluding Specimen Stability):

6.3.1. Claimed Shelf-Life: Provide information on stability testing studies supporting the claimed shelf life of the device. Testing should be conducted on at least three lots manufactured under conditions equivalent to routine production. Accelerated studies may be used initially but must be followed up with real-time stability studies. Include details such as study protocols, acceptance criteria, testing intervals, methods used for accelerated studies, and conclusions.

6.3.2. In-Use Stability: Detail in-use stability studies for one lot reflecting actual routine device use, including open vial stability and/or on-board stability for automated instruments. For automated instrumentation claiming calibration stability, include supporting data. Provide study reports, protocols, acceptance criteria, testing intervals, conclusions, and claimed in-use stability.

6.3.3. Shipping Stability: Describe shipping stability studies for one lot of devices, evaluating tolerance to anticipated shipping conditions. These studies may be conducted under real or simulated conditions, including extreme heat and cold. Information should include study reports, protocols, acceptance criteria, methods for simulated conditions, conclusions, and recommended shipping conditions.

6.4. Software Verification and Validation: Provide evidence of software validation in the finished device, including summary results of verification, validation, and testing performed in-house and in an actual user environment before final release. Address all hardware configurations and operating systems specified in the labeling.

6.5. Additional Information Required in Specific Cases:

(a) Sterile or Defined Microbiological Condition: Describe environmental conditions for relevant manufacturing steps. For sterile devices, provide methods and validation reports for packaging, sterilization, and maintenance of sterility, addressing bioburden testing, pyrogen testing, and sterilant residue testing.

(b) Devices Containing Tissues, Cells, or Substances of Animal, Human, or Microbial Origin: Provide information on the origin and collection conditions of such materials.

(c) Devices with Measuring Function: Describe methods used to ensure accuracy as specified in the device specifications.

(d) Devices Connected to Other Equipment: Describe resulting combinations when connected to other equipment, ensuring conformity with general safety and performance requirements set out in Annex I. Provide proof of conformity considering manufacturer-specified characteristics.