Technical documentation

The regulations define additional detail for the content of the Technical Documentation – often referred to as the Technical File – for each medical device or family and require that the information is presented in a clear, organized, readily searchable and unequivocal way. The regulations also reinforce the emphasis on the requirements driving a lifecycle approach to the management of the medical device with the routine updating of the Technical Documentation, including:

• in the light of information gathered during post-market surveillance;
• evolution in the state of the art; and
• development of changes to standards or common specifications used to support CE-marking.

The Technical Documentation includes the:

• device description and specification, including reference to previous and similar generations of the device;

• information supplied by the manufacturer on labels and accompanying documents, including any symbols used;

• design and manufacturing information;

• demonstration of conformity with general safety and performance requirements;

• risk management information and riskbenefit determination;

• product verification and validation information, including:

• pre-clinical and clinical data; and
• additional information in specific cases where a device: • incorporates a medicinal product;
• is manufactured utilizing tissues or cells of human or animal origin, or their derivatives;
• is composed of substances or combination of substances that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body;
• contains hazardous substances;
• is placed on the market in a sterile or defined microbiological condition;
• is placed on the market with a measuring function; and/or
• is to be connected to other device(s) in order to operate as intended,
  

• technical documentation on PMS, including:

• post-market surveillance plan; and
• periodic safety update report for class II or class III devices or post-market surveillance report for class I devices;
• EU declaration of conformity.

The Technical Documentation needs to be controlled as QMS documentation. In large organizations, it is likely that the documentation will be generated by a variety of different functions depending on how the organization is structured – for example: Quality Assurance, Manufacturing, Supply Chain, Regulatory Affairs, R&D, Clinical/ Medical, Safety – and the document management system(s) need to enable the Technical Documentation to be organized, up-to-date and readily searchable throughout the device lifecycle.

The following are some key questions:

• Does your document management process enable the Technical Documentation to be organized and readily searchable, and be kept up to date throughout the device lifecycle?
• What new documents do you need to include in your Technical Documentation?
• Do you have processes to monitor the adoption of new standards or common specifications, or changes to existing standards or common specifications? How do you assess the effect of such new or revised documents on your Technical Documentation?

This is an excerpt from the forthcoming white paper Implementing the European Union Medical Devices Regulations. To download our other medical device white papers, please visit the Insight page on the Compliance Navigator website.