Do you differentiate Indications and Medical conditions in your documents?

When preparing the CER or PMCF Plan and Report you could potentially be facing some uncertainties regarding the terms ??medical conditions?? and ??indications??

Let's explain these two terms in more detail.

Medical indications are the facts and their interpretations about the patient's physical and/or psychological condition that provide a reasonable basis for the physician's clinical judgments aiming to realize the overall goals of medicine: prevention, cure etc.

Ex. These cosmetic procedures are not medically indicated for a diagnosable medical condition.

Ex. Do patient age and medical conditions influence medical advice to stop smoking?

According to the MDCG 2020-6 ‘indication’, ‘indication for use’: refers to the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the medical device.

In addition, the PMCF Plan Template describes medical conditions and Indications in section B of the MDCG 2020-7.?

4 It refers to the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the medical device

Neither MDR nor MDCGs differentiate the meaning of the medical condition and indications.

Based on the statement above, medical conditions and indications appear to be the same.

Since the two terms are not entirely clear to distinguish, they could under certain circumstances lead to questions by the Notified Body.

With this in mind, please pay careful attention when using these terms in your documentation to avoid unnecessary questions.