1.1 General description

This document provides a comprehensive overview of the medical device, covering everything from its basic function and intended use to its configuration, accessories, and historical background.

We can outline the structure and content of a well-prepared General Description document. While the specifics vary depending on the type of device (e.g., software, medical gloves, or electrolarynx devices), the fundamental components remain largely the same.

Structure and content of the general description document

At its core, the General Description document serves as an introduction to the medical device. It lays the groundwork for regulatory assessments and ensures that all relevant stakeholders—including Notified Bodies, regulators, and internal compliance teams—have a clear understanding of the product.

Manufacturer and regulatory identifiers

The document typically starts with the manufacturer's details, including:

• Company name and address
• Basic UDI-DI (Unique Device Identification - Device Identifier)
• Document version and approval history

This section ensures traceability and establishes the official regulatory identity of the device.

Device overview and intended purpose

A concise general description of the device follows. This section highlights:

• What the device is
• How it functions
• Its primary purpose in a clinical setting

For example, in the case of latex gloves, the description specifies that they are non-sterile examination gloves used to prevent infections. In contrast, a medical imaging software product would focus on image acquisition, processing, and analysis functionalities.

Product variants and configurations

Devices often come in multiple versions or configurations to suit different medical applications. This section outlines:

• Product variants (e.g., powder-free vs. powdered gloves, different software modules)
• Size options and colors (if applicable)
• Any distinguishing features that differentiate one model from another

For software-based medical devices, this section may include details on modular components, clarifying which parts qualify as medical devices under MDR and which do not.

Accessories, disposables, and spare parts

Some devices work in conjunction with accessories, disposable components, or replacement parts. This section clarifies:

• Whether additional items are required for the device to function
• Any related consumables that must be replaced periodically
• Spare parts that might be needed over the device's lifespan

For some devices, such as examination gloves, these categories may be marked as not applicable (N/A).

Combination with other products

Certain medical devices are designed to function in combination with other equipment. This section explains:

• If the device can be integrated into a larger system
• Whether it requires a specific platform or software
• How compatibility with other medical devices is ensured

Device classification and regulatory pathway

The classification of the device under MDR (Annex VIII) is referenced here. This determines the conformity assessment route and the level of regulatory oversight required.

Application, indications, and contraindications

This section provides a clinical context for the device’s use, answering key questions such as:

• What medical conditions or procedures the device is intended for
• Who the intended users are (professionals, laypersons, etc.)
• Whether there are any specific contraindications or risks

Single use, cleaning, and maintenance

For single-use devices, this section explicitly states that reprocessing is not permitted. For reusable devices, it provides details on:

• Cleaning, disinfection, and sterilization procedures
• Expected device lifespan and replacement guidelines

Product documentation and regulatory compliance

A note on documentation storage and accessibility is typically included. This ensures that:

• Regulatory authorities can access required records during audits
• Documents are maintained for the necessary post-market surveillance period

Device history and market availability

A brief history of the device’s development, production, and distribution is often included. This might outline:

• Initial product launch year
• Geographical markets where the device is distributed
• Significant product modifications over time