Polish Medical Device Law Renewed – Published on cemarking.net – April 27, 2022
Finally, the new Polish national legislation on medical devices is a reality. The new regulations were signed by the President on April 20, 2022.
This has led to better consistency between the national law and the European directives. It now aligns with EU Regulation 2017/745 (on medical devices, the MDR) and EU Regulation 2017/746 (on in vitro diagnostic medical devices, the IVDR).
Key Points Defined in the New Regulations
The most essential provisions deal first of all with the information obligations of economic operators on the market of medical devices and in vitro diagnostic devices. At the same time, rules for advertising medical devices are defined. Finally, the law describes the system of administrative sanctions related to non-compliance with the MDR, the IVDR or the law.
Advertising for Medical Devices
Never before had Polish regulation of medical device advertising been established. Now there is. Nevertheless, the term “advertising” is not factually defined. Advertising aimed at the general public must contain understandable language so that even a layman can know what it is about.
What is Not Allowed in Medical Device Advertising?
A number of rules have been laid down stating what is not allowed. First of all, it is not permitted to show an image of someone who practices or claims to practice, a medical profession. This also means that the presentation of the product in question may not be done by a medical professional. Similarly, the suggestion of such a professional is also prohibited.
In addition, the advertising must not be aimed directly at children. This group may in no way be urged to buy the product itself, nor persuaded others to do so. Furthermore, the advertisements may not relate to specific professional devices. It may only be about medical devices used by laymen.
Finally, Article 7 of the MDR and Article 7 of the IVDR lay down some additional proscripts. These deal with claims made in relation to the medical device. The new Polish law now states that advertising must not violate the rules as laid down by these two articles.
What is Required to be Stated in Medical Device Advertising?
There are two things that every advertisement must contain at least. First, of course, there is the name or trade name of the product. Next, it is mandatory to describe the intended use.
The Minister of Health is going to draft another supplementary regulation. This will not only include detailed regulations regarding the necessary information in advertisements. They will also include the manner in which advertisements should be made.
Further Provisions on Advertising
In summary, the new regulations also provide guidance on a number of issues. For example, it answers the question of who may advertise medical devices. Furthermore, the law defines, among other things, who is responsible for advertising. In addition, the new regulations also lay down to which other advertising-related activities the described provisions apply.
Violators
Measures can be taken if the rules are violated. This may involve correcting the violation or stopping the publication. The public publication of a correction can also be a measure.
Register of Distributors
There will be a national register of distributors. These are the companies that market devices, systems and procedure packaging located in Poland. The first time this happens, the distributor has to apply to be on the list. That application is made by the dealer to the president of the URPL. In Poland, this is the agency for the registration of medicines, medical devices and biocides.
As well as explaining the registry and where a distributor can submit their registration, the rule also provides guidance on what a request must meet.
Administrative Fines
When the law is violated, a fine can be imposed. In the worst case, this can be as much as 1.1 million euros. On the other hand, there are also provisions that allow the penalty to be mitigated.
When do the Law and the Additional Provisions Enter Into Force?
These Polish national regulations are valid as of May 26, 2022. There is also the part of the supplementary provisions concerning the advertising of medical devices. It is expected that this part will come into effect on January 1, 2023.
Finally, there is a part that frames the provisions on the registration of devices and market participants. That part is expected to take effect on July 1, 2023.
Conclusion
The medical device industry continues to undergo significant changes. We are nearing the end of the legislative process for Poland’s new medical device law will radically change the current environment for doing business in Poland’s medical device sector.
Polish Medical Device Law Renewed, Links and Downloads
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