What is BS EN ISO 18113-2:2016

Introduction

BS EN ISO 18113-2:2016, also known as the European Standard for In vitro diagnostic medical devices - Information supplied by the manufacturer (IVD MDs), is a set of guidelines and requirements aimed at ensuring the safe and effective use of in vitro diagnostic medical devices. This standard provides manufacturers with guidance on how to design, manufacture, and label these devices, while also ensuring that they meet the necessary quality and performance standards.

Key Components of BS EN ISO 18113-2:2016

1. Device description and specifications

BS EN ISO 18113-2:2016 requires manufacturers to provide a detailed description of their device, including its intended use, principle of operation, and any specific warnings or precautions. This helps users understand the device's purpose and limitations.

2. Manufacturing process

The standard outlines the necessary requirements for the manufacturing process, such as documentation, traceability, and risk management. It also emphasizes the importance of quality control measures to ensure consistent and reliable device performance.

3. Labeling and packaging

Clear and informative labeling is crucial to help users identify and correctly use the device. BS EN ISO 18113-2:2016 specifies the necessary information that should be included on the label and packaging, such as the device name, model number, lot number, storage conditions, and instructions for use.

Benefits and Impact

BS EN ISO 18113-2:2016 plays a crucial role in ensuring the safety and performance of in vitro diagnostic medical devices. By complying with this standard, manufacturers can enhance the quality and reliability of their products, thereby reducing the risk of incorrect diagnoses or patient harm.

Furthermore, the standard promotes harmonization and consistency in regulatory requirements across different countries, simplifying the process of obtaining market approvals for manufacturers. This facilitates international commerce and ensures that users have access to safe and effective medical devices worldwide.

Overall, BS EN ISO 18113-2:2016 is an important tool for both manufacturers and users, providing guidance on how to develop, produce, and utilize in vitro diagnostic medical devices in a responsible and safe manner.