The Intended Purpose

The essence of every medical device lies in its intended purpose and intended use. The formulation and content of these specifications significantly influence the benefit-risk assessment, required clinical data, verification and validation processes, as well as marketing strategies. Our team of experts vigilantly examines all interfaces, combining regulatory knowledge with a comprehensive understanding of lifecycle processes to find the optimal path for your product’s success.

Intended use, as defined in EN ISO 14971, encompasses various elements such as indications, target group, environment of use, and mode of action.

On the other hand, the FDA does not distinguish between the terms and solely defines “intended use.” While the MDCG document 2020:6 equates both terms, its non-legally binding nature raises questions about whether this approach always makes sense.

There are potential drawbacks to including all information of the intended use within the intended purpose. This practice can result in excessively long and detailed specifications, making minor changes lead to significant alterations in the intended use wording, potentially causing inconsistencies in the documentation over time.

Additionally, specifying all details in the intended purpose may not be feasible or practical in all instances, such as when declaring conformity or grouping related products.

In light of these considerations, there remains room for interpretation, and each manufacturer should decide the most suitable approach based on their specific product.

Regardless of the chosen path, defining the purpose early in the development process is of utmost importance. It serves as the foundation for all subsequent development activities and post-market phases.

At IVDRconsulting, we offer a wealth of experience and tailored solutions to accompany you throughout this journey, providing answers to your questions and assistance with any challenges you may encounter.