Stages for placing medical devices on the market – EU and Polish regulations
In order to ensure the greatest possible safety for the patient, the manufacturer must notify and register the medical device before placing it on the market. However, before this can happen, a number of conditions must be met. On 26 May 2021, the revision of EU medical device legislation came into force. These regulations are governed by Regulation 2017/745 of the EU Parliament and Council of 5 April 2017 (MDR Regulation) on medical devices. In Poland, the register of medical devices placed on the market or put into use and the entities responsible for their introduction is kept by the Polish President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
What is a medical device?
Under Polish law, in accordance with Article 2 of the Act on Medical Devices of 20 May 2010, a medical device is: “an instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including software intended by its manufacturer to be used specifically for diagnostic or therapeutic purposes and necessary for its proper application, intended by its manufacturer to be used for human beings with a view to
- the diagnosis, prevention, monitoring, treatment or alleviation of disease,
- to diagnose, monitor, treat, alleviate or compensate for the effects of an injury or handicap,
- studying, replacing or modifying an anatomical structure or a physiological process,
- regulation of conception” [1]
MDR Regulation
According to Regulation MDR 2017/745, the placing on the market of devices is defined as, the first transfer, against payment or free of charge, of a brand new or completely reconstituted device with a view to use or distribution within the territory of a Member State. In contrast, putting into service shall mean the first making available to the user within the territory of a Member State of a device which is ready for use, with a view to its intended purpose. The main objectives of the MDR Regulation are to establish uniform regulations for the medical device market in the European Union, to make it easier to identify the devices themselves and the entities responsible for their manufacture and distribution. [2]
Main responsibilities of distributors
The MDR Regulation introduces new obligations for distributors and expands on existing ones. The main obligations of distributors are described in Article 14 of the Regulation. Before a distributor places a product on the market, he must check its compliance with the requirements:
- presence of CE marking and EU Declaration of Conformity,
- labelling of the product in accordance with the MDR – whether it has the required instructions for use,
- the presence of the manufacturer’s UDI code, where applicable,
- that the label and the instructions for use contain information in the language required by the country in which the product will be sold. [3]
Placing medical devices on the market – conditions
Devices placed on the market, put into service, submitted for performance evaluation, distributed, supplied, made available, installed, put into service and used must:
- meet specific essential requirements for the design, manufacturing, packaging and labelling of the product,
- have a declaration of conformity duly drawn up. Before medical devices are placed on the market for the first time, they must undergo a conformity assessment procedure. It confirms whether a given product meets all the essential requirements that apply to it. The procedure is carried out depending on the class of the medical device, which indicates the risk of its use. For medical devices in risk class I, the manufacturer carries out the conformity assessment himself, then issues the declaration of conformity and marks his device with the CE mark. For devices of higher risk classes, a notified body must participate in the conformity assessment procedure. For this purpose, the manufacturer can turn to any unit. The notified bodies authorised by the Minister of Health based in Poland are:
- Polskie Centrum Badań i Certyfikacji S. A.
- TÜV NORD Polska Sp. z o.o. [4]
Following the conformity assessment, the manufacturer shall draw up a declaration of conformity. In it, he confirms that the product complies with the essential requirements applicable to it.
Certificate of compliance
Certificate of compliance applies to medical devices in which a notified body has participated in the conformity assessment. It confirms that the product meets the essential requirements applicable to it. It contains the name and number of the notified body, certificate identification number, name and address of the manufacturer, identification of the conformity assessment procedure, conclusions of the conformity assessment, date of the certificate.
CE marking
Products placed on the market and put into service must also be properly CE-marked.
The CE mark is the manufacturer’s declaration that the product which has been placed on the market conforms to the essential requirements and quality and safety standards applicable to that product. [5]
Other requirements
Devices placed on the market and put into service must also be safe for the life and health of patients, users or other persons and not pose a risk or exceed acceptable risk limits when correctly supplied, installed, maintained and used in accordance with the manufacturer’s intended purpose. They must have specific information on the function to be performed, on the performance of the device and on the potential risks involved in using the medical device. They must also be provided with appropriate labelling, instructions for use and information material which cannot mislead the user with regard to the characteristics and performance of the device and the handling of the device in use.
Before being placed on the EU market for the first time through the Polish market, a medical device must be notified to the Polish President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products – at least 14 days before the first device is placed on the market. [6]
[1] https://sip.lex.pl/akty-prawne/dzu-dziennik-ustaw/wyroby-medyczne-17625064
[2] https://www.meddev.pl/wymagania-prawne/warunki-wprowadzania-do-obrotu-i-uzywania
[3] https://eur-lex.europa.eu/legal-content/PL/TXT/PDF/?uri=CELEX:32017R0745&from=IT
[4] https://www.gov.pl/web/zdrowie/wprowadzenie-wyrobow-medycznych-do-obrotu-i-do-uzywania
[5] Ustawa z dnia 20 maja 2010 r. o wyrobach medycznych, Dz.U. 2010 Nr 107 poz. 679
[6] http://www.urpl.gov.pl/pl/wyroby-medyczne/zg%C5%82oszenia-wyrob%C3%B3w-medycznych
