Intended purpose of a medical device according to MDR
A correct and precisely formulated intended purpose of your medical device is crucial for its successful development and approval. However, the definition of terms and the distinction between the intended purpose and the intended use often makes it difficult to formulate the intended purpose clearly and unambiguously.
The intended purpose forms the basis for the qualification and classification of a medical device and determines the choice of the approval procedure. In addition, the intended purpose according to ISO 14971 contains a risk assessment of the medical device, of which further product requirements can be derived. The intended purpose of a product is also necessary to determine equivalent products.
In addition, the intended purpose forms the basis for the validation and clinical evaluation of a medical device. Manufacturers must demonstrate that their medical device can fulfil its intended purpose for the intended user in the intended context of use. This includes clinical evaluation as well as summative device evaluation.
The advantage of a clear and precise formulation of the intended purpose is that it defines the benefit and the field of application of your medical device in your company in a uniform manner. Therefore, make sure that the intended purpose is consistent in all relevant documents!
Furthermore, it should be noted that the intended purpose is not a functional description. An intended purpose describes exclusively what is to be achieved with a medical device.
Content of intended purpose
Summary of the most important contents of a medical device’s intended purpose according to the EU MDR:
|Medical purpose||Treatment, mitigation, diagnosis, monitoring|
|Characterisation of the patient(s) and indication(s)||Diseases, concomitant diseases, age, gender, physical and mental abilities, application areas/tissues|
|Characterisation of the user||Academic education, areas of responsibility, physical and mental abilities, experience with product/class, necessary equipment, or tools In an app, users can also be patients!|
|Context of use:|
|Physical environment||Brightness, humidity, pollution, vibration, temperature|
|Social environment||Stress levels, workload, shift work, distractions|
|Types of environments (according to IEC 60601-1)||Home, Health care, Professional health care, special environment|
|Exclusions: What should the MD not be used for?||Depending on the individual intended purpose of the medical device|
|Intended use: can/should be done with the MD that does not directly correspond to the medical purpose?||Software updates/configuration, cleaning/sterilization, transport, storage, disposal|