In practice, the classification of a product as a medical device may raise significant doubts. In particular, this applies where it is unclear whether a particular product should be subject to the legal regime applicable to medical devices or medicinal products.
In accordance with art. Whereas article 2 (2) of Regulation (EEC) No 1 point 38 of the Act of 20 May 2010 on medical devices (Journal of Laws of 20 May 2010). U. of 17 June 2010), a medical device, device, device, software, material or other article, whether used alone or in combination, including software intended by its manufacturer for use specifically for diagnostic or therapeutic purposes and necessary for its proper use, intended by the manufacturer for human use for:
(a) diagnosing, preventing, monitoring, treating or alleviating the course of the disease,
(b) diagnosing, monitoring, treating, mitigating or compensating for the effects of injury or impairment,
c) testing, replacing or modifying the anatomical structure or physiological process,
(d) the regulation of conception
– the essential intended action of which in the human body or body is not achieved by pharmacological, immunological or metabolic measures, but whose action may be assisted by such means.
On the other hand, in the light of Article 2(10) Article 2(32) of the Law of 6 September 2001. Pharmaceutical law, a medicinal product, is a substance or mixture of substances, presented as having the characteristics to prevent or treat diseases occurring in humans or animals, or administered for the purpose of diagnosis or for the restoration, correction or modification of physiological functions of the body by pharmacological, immunological or metabolic action.
Pharmaceutical law expressly states that where one product meets both the criteria of a medicinal product and the criteria of another type of product, e.g. a medical device, pharmaceutical law applies to it. Where a medical device or an active medical device for implantation contains, as an integral part, a substance which would be used separately as a medicinal product and which may act on the human body in addition to a medical device or an active medical device for implantation, the provisions of the Law on Medical Devices shall apply. A similar solution applies to a situation in which a medical device is intended for the administration of a medicinal product. Specific rules apply to the placing on the market of a medical device in such a way that it creates with the medicinal product a single inseparable product which is intended for use only in a given combination and which is not reusable. Such a product is governed by the pharmaceutical law, although the relevant essential requirements laid down in the Law on Medical Devices also apply to it, but only to the extent that they concern the characteristics of the medical device in question relating to its safety and performance.
In addition, the Law on Medical Devices points to a basic interpretative directive for determining whether a product should be regarded as a medical device or a medicinal product, specifying that the essential course of action of the product in question is decisive.
It should also be noted that, in the light of the above-above definition of a medical device, the intended use of the medical device given to it by its manufacturer is crucial in its classification, which means that it is the decision of the manufacturer that is very important in this regard. Of course, it is bound by law and has a de facto narrow margin of discretion, and in the event of non-compliance, the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products may always refuse to register the device in question.
An example of difficulties in the proper legal qualification of a given product may be eard for various purposes eye drops. Those which primarily have pharmacological, immunological or metabolic effects will be included in medicinal products if they can be used or given to patients to restore, improve or modify the physiological functions of the body. On the other hand, products specially designed for disinfection, washing, rinsing or humidification of contact lenses are medical devices. However, drops that are intended to treat eye damage caused by environmental factors can be considered as both medical devices and medicinal products, depending on their basic mode of action, provided that they clearly indicate their function in the treatment or relief of damage, eye irritation.
An interesting example is also warming patches containing capsaicin. These were intended, among other things, for local anesthesia and treatment of muscle pain, rheumatic pain or migraine. In this case, it was established that such a patch should be considered as a carrier of a given substance (capsaicin), which thanks to it is delivered to the body, where it causes an analgesic effect. It cannot therefore be excluded that the product concerned achieves its main objective by means of a pharmacological agent. Therefore, these patches cannot be classified as a medical device[i].
[i] Examples from MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES version 1.12 (04-2012)
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