When medical garment is a medical device – communication from the Polish authority

In May 2024, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (President of the URPL) issued a Communication on the principles for determining the regulatory status of medical garments (Communication). In the Communication, the President of the URPL outlined the evaluation criteria it follows when issuing an opinion on whether used garments in healthcare facilities meet the definition of a medical device.

The President of the URPL explained that, depending on its intended use, it will have a different regulatory status, and will be subject to different national and community regulations applicable to medical devices, personal protective equipment or hygiene articles. The key to assessing whether a medical garment should qualify as a medical device is to determine the manufacturer’s intended use of the garment, and to identify whether this use is medical use within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR). The mere designation of a garment as "medical", in the opinion of the President of the URPL, is not sufficient to determine that it will have a medical use within the meaning of the MDR.

The President of the URPL pointed out that for a garment to be considered a medical device within the meaning of the MDR, it is necessary for its manufacturer to state its intended use for medical purposes on the label, in the instructions for use, and in promotional materials. If the manufacturer of a medical garment demonstrates its compliance with certain requirements of the MDR, but does not specify its intended use for medical purposes on the label, in the instructions for use or in promotional materials, then – despite bearing a CE mark and issuing a declaration of conformity for it - this product will not meet the definition of a medical device.

In the opinion of the President of the URPL, the following medical-clothing products that protect against the transmission of infectious agents from medical personnel to the patient can be classified as medical devices:

• surgical gowns;
• clothing for operating theatres (clean-room clothing).

The medical context of these devices is based on their direct (positive) impact on the patient's health during a medical procedure. Without the use of these devices, the health or life of the patient undergoing the procedure is at risk. In addition, both surgical gowns (which must be either sterile or designed to be sterilised) and operating theater garments (which must be either a one-piece or two-piece suit) are subject to the strict requirements of European standards.

In the Communication, the URPL President also referred to disposable medical gowns, which he does not recognise as a medical device if they:

• protect against the transmission of infectious agents from visitors to patients;
• protect against the transmission of infectious agents from one patient to another patient by medical personnel;
• protect medical personnel from infectious agents from patients.

If manufacturers state on the label, in the instructions for use or in promotional materials for disposable medical gowns that the gowns protect against the transmission of infectious agents from visitors to the patient, it must be remembered that visiting a patient is not a medical purpose, and, according to the CJEU judgment in Case C-219/11, only a product whose use has a medical purpose can be considered a medical device.

Disposable medical gowns that protect against the transfer of infectious agents from one patient to another patient by medical personnel do not protect the patient in any way. They are disposed of after each use, and do not prevent disease, which is one of the purposes of using a medical device as specified in its definition.

Medical gowns that protect medical personnel from infectious agents on patients are not medical devices, but are personal protective equipment, since they are designed to protect those wearing them from hazards that can have very serious consequences, such as death or irreversible damage to health, associated with harmful biological agents.

In addition, clothes intended for use by medical personnel when washing their hands before a surgical operation are not medical devices, according to the Communication. In the opinion of the President of the URPL, such clothes, as well as brushes and sponges intended for washing nails, hands and arms of medical personnel before surgical procedures, should be classified as hygiene articles.

For more information on this Communication and regulations surrounding medical devices in Poland, contact your CMS client partner or these CMS experts.