Poland: The President has signed the Act on Medical Devices, coming into force on 26.05.2022.
After nearly two years of legislative work – we have a new law on medical devices. It enters into force exactly one year after the application of Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices. Of course, the regulation applies directly, but in the explanatory memorandum of the bill you can read about the areas that are left to the Member States and their regulatory authorities.
These issues include principles for advertising medical devices, introduction of provisions regulating the possibility of reprocessing and further use of single-use medical devices, and the definition of requirements concerning the languages in which documents relating to marketing of medical devices are to be drawn up. The new law also introduces information obligations for entrepreneurs operating in the medical device market. These obligations are accompanied by a system of administrative penalties.
As we recall, in the still-existing Act the word ‘advertising’ does not appear at all, and promotion of medical devices was mentioned in a single paragraph in Article 8. Meanwhile, in the new Act, advertising is regulated by a whole separate Chapter 12 (Articles 54 to 61). The obligations of an entrepreneur running a medical device advertisement include keeping samples of advertisements and information about the places where they are distributed for a period of 2 years from the end of the calendar year in which the advertisement was displayed.
It is interesting to note the use of the term „lay person”, inter alia in the context of the addressee of a medical device advertisement. The Act uses this wording in the wake of Regulation 2017/745, where the definition of lay person is contained.
Under the new law, reprocessing single-use devices is allowed in Poland. However, this is only strictly in accordance with the rules set out in Regulation 2017/745. It is further provided that the President of URPL, in the event of a breach of the EU provisions on reprocessing, will issue an administrative decision to withdraw from the market (or from use) reprocessed single-use devices, if this is justified by the need to ensure public health protection and patient safety.
An important novelty is also the list of distributors of medical devices, systems or treatment sets, maintained by the President of URPL (the so-called list of distributors). A distributor who makes a medical device available in Poland for the first time, submits an application to the President of URPL for an access code and password to the list of distributors. Then the distributor enters on this list, among others, the Basic UDI-DI code of the product according to the Eudamed database, and other data, according to the label.
Time will tell how the market – with the experience of pandemics and war – will cope with implementing the new procedures.
Source: Act of 7 April 2022 on Medical Devices (parliamentary print No. 1764)