Technical documentation section 3. Design and manufacturing:

3.2 Description of manufacturing

The "Description of manufacturing" is a required part of the technical documentation as per Annex II of Regulation (EU) 2017/745 on medical devices (MDR). It provides detailed information about the manufacturing processes used to produce the medical device, ensuring that these processes consistently result in a product that complies with its specifications and regulatory requirements.

Purpose of the manufacturing description

This section allows Нотифицированная организация and competent authorities to evaluate whether the manufacturing processes are adequately designed and controlled to ensure product quality, safety, and compliance. It also supports the conformity assessment procedure and helps identify critical process controls and risk points.

Content of the manufacturing description

• Overview of the full manufacturing process, from raw material input to final packaging and labeling
• Identification of all manufacturing sites and subcontractors involved
• Flow chart or diagram of the process steps
• Description of process controls and in-process checks
• Details of production environment conditions (e.g., cleanroom classifications)
• Information on equipment, machinery, and software used in manufacturing and control
• Traceability and batch control mechanisms

Integration with other documents

The manufacturing description should align with the СМК procedures, including production controls, validation protocols, and traceability records. It may reference or include related documents such as standard operating procedures (SOPs), validation reports, and process qualification documents.

Considerations for different types of devices

Depending on the nature of the device, the level of detail and focus areas of the manufacturing description may vary. For example, implantable devices may require more detailed descriptions of sterilization, surface treatments, and biocompatibility-related processes.

Sterilization processes

When applicable, the sterilization methods (e.g., ethylene oxide, gamma radiation) should be described in detail, including validation studies and routine monitoring activities. These are crucial for proving the safety and effectiveness of the finished product.

Software in production and inspection

If software is used in the production or inspection process, its validation and control should be described. This includes the role of the software, its qualification, and any procedures ensuring its reliability.