Understanding Our Patches
The patch market offers a wide variety of products: wellness accessories, gadgets with no medical basis, and a few genuine medical devices. STIMCARE patches fall into the latter category. Behind this somewhat technical term lie high standards and, above all, concrete guarantees for you. Let us explain it simply.
A medical device (MD) is not a drug. It is a product to which the manufacturer assigns a medical purpose, such as helping to relieve pain, but which works through physical means, without any pharmacological effect on the body. This is what distinguishes a STIMCARE patch from a simple comfort accessory: it is intended for a specific purpose—pain relief—and is regulated by the European Regulation on Medical Devices (MDR 2017/745).
Medical devices are classified according to their risk level, ranging from Class I (the lowest) to the Class III (the highest, such as a cardiac implant). This classification depends, in particular, on the invasiveness of the product, the duration of its contact with the body, and whether or not it contains a power source.
A product that's taking off on intact skin, without delivering any substance and without an external power source, falls under Class I. This is exactly the case for STIMCARE patches (Rule 1 of Annex VIII of the MDR).
Three simple reasons:
These three characteristics naturally classify STIMCARE patches as Class I devices.
This is the most important point. Being a Class I medical device isn't just a marketing label—it's a set of requirements that the manufacturer must meet, and therefore a set of guarantees for you.
Conversely, a simple wellness accessory has none of these requirements. That’s the key difference between a patch that’s truly regulated and a gadget that’s just wrapped up in pretty packaging.
Let's be clear and honest: a Class I medical device is not a drug, and it is not a substitute for medical advice. A STIMCARE patch helps reduce pain ; this is not a guarantee of recovery. If you experience persistent or unusual pain, you should consult a healthcare professional.
The CE marking is not an end in itself; it is a starting point. STIMCARE continues its clinical evaluation efforts to better document the benefits provided by its patches and to expand the data accompanying each product.
This is also what fundamentally distinguishes a medical device from a simple wellness accessory: its status ultimately opens up a path—subject to the required evaluations (particularly by the Haute Autorité de Santé, with a view to reimbursement eligibility)—that remains, by its very nature, closed to comfort products. We are not currently eligible for reimbursement, but it is precisely this goal that we are working toward, study by study.
Choosing a STIMCARE patch means choosing a product that has met a rigorous set of standards rather than cutting corners. Behind those two words, «Class I,» lie safety, traceability, and a genuine medical purpose. It is this commitment to quality that we put into each of our patches.
What is a Class I medical device? Find out why STIMCARE patches are classified as such and learn about the concrete benefits this classification offers you.
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