what is the purpose and character of the intended use?
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Explanation:
Date
04.02.2020
Author
Jessica Wyler
Category
Knowledge
Reading Time: 7 minutes
The intended purpose – or, what does your medical device do?
When deciding whether a product qualifies as a medical device, the intended purpose of the device is crucial. But what exactly is the intended purpose? What do manufacturers have to consider when defining the intended purpose? And how important is the exact wording?
It is not without reason that the correct formulation of the intended purposes of medical devices is crucial for their successful development and regulatory approval . In this post, we will discuss the intended purpose of medical devices with reference to the regulatory framework of the European Medical Device Regulation (EU) 2017/745. While the US FDA uses the term intended use, intended purpose and intended use are often used synonymously in the EU, and both terms are mentioned in the
The MDR defines the intended purpose in Article 2(12) as follows:
‘Intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation;
The manufacturer of a medical device is responsible for defining the intended purpose of the device, which has far-reaching consequences: the first is the basis of the decision whether or not a product is a medical device, in accordance with the definition of the regulation. The definition mentions documents such as label, instructions for use, and promotional or sales materials as well as the clinical evaluation