In The Debrief, our Practice Leaders across CEE share updates on recent and upcoming legislation, consider the impact of recent court decisions, showcase landmark projects, and keep our readers apprised of the latest developments impacting their respective practice areas.
Under the Polish Medical Devices Act of 7 April 2022 (the MDA), surveillance over medical device advertising is exercised in principle by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (the URPL), and in certain cases, by the Minister of Health or the Chief Sanitary Inspector.
The draft regulation of the Minister of Health on medical device advertising (the Draft) provides for further restrictions and requirements on advertising to the public. The Draft is intended to be a clarification of the technical requirements for advertising medical devices that have been introduced at the statutory level in the Polish Medical Devices Act of 7 April 2022 (the MDA).
As a rule, medical device advertising can be conducted by economic operators, i.e. manufacturers, distributors, authorized representatives and importers (Article 56 (1) of the Polish Medical Devices Act of 7 April 2022 (the MDA)). Other entities can conduct advertising only after approval of the advertisement in writing by the economic operators.
As in the case of EU Regulations 2017/745 on medical devices (the MDR) and 2017/746 on in vitro diagnostic medical devices (the IVDR), the Polish Medical Devices Act of 7 April 2022 (the MDA) does not provide any definition of advertising. It can therefore be difficult for the industry to understand in practice which activities are likely to be treated as advertising by the regulatory authorities. Whilst the new legislation provides for stricter rules for advertising addressed to the general public, the MDA fails to provide guidance on what the advertising to the general public in fact is and determine a clear distinction between such activities and the advertising directed to non-laymen.
1 January 2023 brought a major change to medical device advertising in Poland. From this date, the new national regime for medical device advertising applies. Therefore, all promotional activities associated with medical devices in Poland need to comply not only with the European Union regulations, but also with the new national requirements.
The Life Sciences & Healthcare industry is not free of criminal activity that may give rise to the companies’ liability for criminal offences. However, the corporate criminal liability in Poland is not effectively enforced now. The government presented its proposal to change that in the new draft law amending the Corporate Criminal Liability Act (the “draft”).
The adoption of the Regulation (EU) 2017/745 on medical devices (MDR) and the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) triggered changes in the medical devices law on the national level in Poland. The new Polish Medical Devices Act of 7 April 2022 (MDA) stipulates entirely new restrictions to advertising of medical devices (Articles 54-61) that were previously unknown to this industry sector and heavy sanctions for infringements of the new rules (Articles 103 and 104).