How to establish a Polish limited liability ready to operate in the market of medical devices and equipment.
The spread of the SARS-Cov-2 virus (coronavirus) causes difficulties in supplying products such as disposable face masks in many places around the world. Products of this type, according to Polish law, are classified as medical devices, i.e. products designed and manufactured to protect the patient or their user from mechanical injuries or to reduce the risk of infection when using these devices.
This article will cover basic rules for production and sale of the medical devices (the below rules does not apply to medicines or dietary supplements, which are subject to the separate provisions of law).
The production and sale of medical devices are regulated by the Act of 20 May 2010 on medical devices. The Act imposes numerous obligations regarding requirements that medical devices must meet. However, the manufacturer or importer doesn’t need to meet any conditions regarding the form of such business. This means that any legal entity may carry out an activity in the production or sale of medical devices.
The market for medical devices is supervised by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (pol. Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych or simply “UPRL”).
Medical devices are divided into 3 classes depending on their type and use. The type of conformity assessment procedure depends on the type of class of the device – the higher the device class, the more stringent the conformity assessment procedure is. For example – gloves for medical examinations – class I, blood containers – class II, vascular prostheses – class III.
Conformity of medical device
Before medical devices enter the market for the first time, they must go through a conformity assessment procedure. The procedure confirms that the product meets all the essential requirements that apply to it.
The procedure is carried out depending on the class of medical device:
- Medical devices of class I – the manufacturer independently performs conformity assessment procedure, issues a declaration of conformity and CE marking on his device.
- Medical devices with higher classes – conformity assessment procedure is made with the participation of Notified Institutions (institutions that meet certain standards and are authorized by the Polish Ministry of Health).
Before placing a medical device on the market, the manufacturer of a device must perform clinical tests of the medical device to confirm the compliance of the device with the requirements regarding the qualities and functioning of the device and to assess the negative effects of the device and acceptability of the clinical benefit/risk ratio under normal conditions of use of the device.
The clinical tests can be started after obtaining the permission of the President of UPRL to conduct these tests.
Obligation to notify the device to UPRL
Before the first placing on the EU market through Poland, a medical device must be notified to UPRL – within 14 days before the device is placed on the market. The placing on the market of medical devices doesn’t, therefore, require obtaining individual licenses for specific devices, but each time the Office must be notified of the introduction of the device. The manufacturer doesn’t have to wait for a reply from the Office.
The CE mark is the manufacturer’s declaration that a device that has placed on the market meets the essential requirements as well as legal regulations, quality and safety standards related to this product.
The CE mark is usually applied by the product manufacturer or his authorized representative – independently and at his own risk. However, if a notified institution was involved in the conformity assessment procedure – the 4-digit identification number of that institution must be placed next to the CE mark.
Import of medical devices to Poland
The medical device importer is responsible for meeting the relevant requirements by the devices he imports. In particular, the importer:
- verifies whether the manufacturer or his authorized representative has carried out the appropriate conformity assessment procedure of the product,
- ensures that the product has the CE marking and information whether an EU declaration of conformity has been drawn up for that product
- ensures that the manufacturer of a device is marked that the information whether the manufacturer has appointed his representative is contained,
- ensures that the device is appropriately marked (per EU regulations) and have instructions for use,
- ensures that additional labels of importer do not prevent the labels of the manufacturer from reading,
- notifies the device to UPRL (if it hasn’t been notified earlier) and the importer based in Poland who introduces a medical device in Poland (not a custom-made device) is required to notify UPRL within 7 days of the first device being introduced,
- provides his name, registered trade name or registered trademark, registered place of business and address where he can be contacted.
If the importer believes or has reason to believe that the device is not in compliance with proper regulations, he cannot place this device on the market until the device is in conformity and he must inform about this the manufacturer and his authorized representative. If the importer believes or has reason to believe that the device in question presents a serious risk or is a fake device, he must inform UPRL about this.
The rules described above apply accordingly to the distributor of medical devices in Poland.
Sale of the medical devices through the Internet
The Act on Medical Devices also contains regulations regarding the sale of these devices via the Internet. The Act treat this type of sale as mail-order sale of devices i.e. a contract of sale of a device concluded with a consumer under an organized system of concluding distance contracts, without the simultaneous physical presence of the parties, with the sole use of one or more means of distance communication up to and including the conclusion of the contract.
At the request of the UPRL, the companies providing means of distance communication are obliged to immediately provide UPRL with data on products and entities selling devices via the Internet, such as:
- name, address of the entity selling the device and, if available, its telephone number, fax number and e-mail address;
- the name or first name and address of the manufacturer;
- trade name and generic name of the product.
The above information is also provided to URPL, at his request, by relevant public authorities.
The breach of the obligation to provide the above data to UPRL is subject to a fine.
Of course, to run a business in Poland you shall need a proper form. In order to be advised on which form will be most suitable for yourself please do not hesitate to contact our law firm.