Hitec Medical MDR training Definition of MDR Terms-Part2

Source:    Published:2023-12-14     Hist:

Intend use

The manufacturer designates the use in clinical evaluation based on the data provided in labels, instructions, promotional or sales materials, or statements.

Label

Printed text or graphic information that appears on the device itself, or on various device packaging or multiple device packaging.

Instruction

Information provided by the manufacturer to inform device users of the intended use, correct usage, and precautions of the product.

 Risk

The combination of probability and severity of hazards.

 Adverse event

In the context of clinical research, regardless of whether it is related to the research device, any adverse medical practices, unexpected diseases or injuries, or any adverse clinical signs, including abnormal laboratory findings, among subjects, users, or others.

 Field safety corrective action

The corrective measures taken by manufacturers for technical or medical reasons are aimed at preventing or reducing the risk of serious adverse events related to devices from suppliers in the market.