On 7 April 2022, the Parliament passed the Act of 7 April 2022 on Medical Devices (the “Act“). It was signed by the President on 20 April.
This long-awaited Act aligns national legislation with EU Regulation 2017/745 on medical devices (MDR) and EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR). Among other things, it defines the information obligations of economic operators on the market of medical devices and in vitro diagnostic devices, the rules for the advertising of devices, and the system of administrative penalties related to non-compliance with the MDR, the IVDR or the Act. Selected issues regulated by the Act are presented below.
1. Advertising of medical devices
The Act lays down rules for the advertising of medical devices for the first time, but without actually defining the term ‘advertising’. However, it indicates that the advertising of a device addressed to the public must be phrased in a manner understandable to a layperson; this also applies to medical and scientific phrases, as well as references in the advertising to scientific research, opinions, literature or scientific studies and other materials directed to users other than laypersons. It cannot:
- use the image of a person performing or claiming to perform a medical profession or depict a person presenting a device in a manner suggesting that they perform such a profession;
- contain a direct appeal to children to purchase the advertised device or to persuade parents or other adults to buy the advertised device for them; and
- concern devices intended for use by users other than laypersons, i.e. professional entities.
The advertising cannot contravene the prohibitions referred to in Article 7 of the MDR and Article 7 of the IVDR, i.e. claims in respect of the device.
The advertising should contain at least the name or trade name of the product and its intended use. Detailed requirements concerning the necessary data and the manner of presenting advertisements are to be specified in a regulation of the Minister of Health.
Only economic operators may advertise devices, but other entities can be granted an approval from the economic operator, in writing, to advertise a device. However, the economic operator is solely responsible for the compliance of the advertising with the legal provisions. An economic operator that is advertising a device to the public is obliged to keep samples of advertisements and information on where it was disseminated for two years from the end of the calendar year in which it was disseminated.
The provisions on advertising also apply to other activities, such as the advertising of a business or professional activity in which a device is used to provide services (to the extent that it concerns services provided with the use of a device, including hiring, renting or lending), the communication of opinions by users of devices to the public if they receive a benefit from it, visiting medical professionals to promote devices, presenting devices during meetings with the aim or effect of encouraging their purchase, financing such meetings, sponsoring fairs, exhibitions, demonstrations, presentations, conferences, congresses, or scientific conventions (including events for healthcare professionals and those who market devices) and presenting devices during such events, and providing samples to promote devices.
Where the President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, “URPL“) finds violations of Article 7 of the MDR or of the IVDR or of the rules on advertising set out in Articles 55 and 56 of the Act, it will order, by administrative decision, the removal of the violations or the cessation of the publication, appearance or conduct of the advertising, or the publication of the decision in the places or media in which it appeared.
2. Register of distributors
The Act introduces a national register of distributors of devices, systems and procedure packs established in Poland. A distributor that makes available for the first time in Poland a device, system or procedure pack must file a request with the President of the URPL for an access code and password to the list of distributors.
The request contains the distributor’s name, address of activity, tax identification number (NIP) or PESEL (for individuals), telephone number, e-mail address and website address, if any. After receiving the access code and password, the distributor enters in the register the Basic UDI-DI code of the device, the system or procedure pack according to the Eudamed database, and the name and address of the manufacturer and the type and trade name of the device, system or procedure pack according to its label. This information should be provided within seven days of the first import of the device, system or procedure pack into Poland.
The register of distributors will be maintained in electronic form and available on the website of the URPL. The published information will include the name of the entity, its registered office and address of activity, telephone number, e-mail address, and website address, if provided.
3. Administrative fines
The Act introduces a number of fines. The highest fines, of up to PLN 5,000,000 (approx. EUR 1,100,000), may be imposed in the following cases:
- marketing or using a device which does not meet the requirements set out in Annex I to the MDR or Annex I to the IVDR (a fine of between PLN 20,000 (approx. EUR 4,300) and PLN 5,000,000 (approx. EUR 1,100,000));
- compiling the technical documentation or its short version by the manufacturer contrary to the requirements set out in Annex II to the MDR and Annex II to the IVDR in a manner which is not clear, structured, easily searchable and unambiguous or which does not contain elements described in these annexes;
- compiling the technical documentation on post-market surveillance by the manufacturer contrary to the requirements set out in Annex III to the MDR and Annex III to the IVDR in a manner which is not clear, structured, easily searchable and unambiguous or which does not contain elements described in these annexes;
- using texts, names, trademarks, pictures and symbols or other signs which may mislead the user or patient as to the intended use, safety and performance of the device, contrary to the prohibition set out in Article 7 of the MDR or Article 7 of the IVDR.
In the case of advertising products contrary to Article 7 of the MDR, Article 7 of the IVDR or Articles 54-60 of the Act, a fine of up to PLN 2,000,000 (approx. EUR 430,000) may be imposed.
However, provisions allowing for the mitigation of fines, including in the above mentioned cases, were eventually included in the Act, i.e. the fine actually imposed may not exceed 10% of the maximum fine for a given act if the infringement on which the fine is based could not pose a threat to the life or health of users or patients; the fine actually imposed may not exceed 50% of the maximum fine for a given act, where the fine is imposed on the same grounds for repeated non-compliance and the infringement on which the fine is based could not pose a threat to the life or health of users or patients.
The relevant authority may also refrain from imposing fines if the infringement was incidental, did not pose a risk, and the infringing entity took actions aimed at its elimination by the deadline indicated by that authority, and informed that authority about these actions.
The Act will enter into force on 26 May 2022. The provisions on the advertising of medical devices are expected to enter into force on 1 January 2023, and some of the provisions on the registration of devices and economic operators are expected to enter into force on 1 July 2023.