Did You Know that, according to the Activity Rankings function of the CEELMDirect website, two CEE lawyers have already authored or co-authored eight thought leadership articles published on the CEE Legal Matters website this year, more than anyone else in the region?
The Debrief: March 2023
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 stay up to date with the latest developments impacting their respective practice areas.
Advertising of Medical Devices in Poland: Surveillance and Sanctions
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.
Draft Regulation of the Polish Ministry of Health On Medical Device Advertising
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).
Forms of Promotional Activities Covered by the Polish Medical Device Act
The Polish Medical Devices Act of 7 April 2022 (the MDA) does not provide a definition of medical device advertising or criteria that could allow a clear assessment of whether an activity is advertising and what requirements it should meet.
Advertising Medical Devices to the Public in Poland
The Polish Medical Devices Act of 7 April 2022 (the MDA) imposes certain restrictions on the medical device advertising that is addressed to the general public. Such advertising activities must not be misleading (Article 7 of the MDR or the IVDR, and Article 55(3) of the MDA), but also must not:
Prohibition of Misleading Advertising of Medical Devices Under EU and Polish Law
The EU regulations (Regulations 2017/745 on medical devices (the MDR) and 2017/746 on in vitro diagnostic medical devices (the IVDR)), introduced a prohibition of misleading advertising of medical devices.
Who May Be Subject to Advertising Regulations in Poland?
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.
What is Medical Device Advertising Under Polish Law?
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.
New Legal Framework for Medical Device Advertising in Poland
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.
Corporate Criminal Liability in Poland – Changes to Affect Life Sciences & Healthcare
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”).
New Advertising Regime for Medical Devices in Poland
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).
MFW Fialek and NGL Legal Advise on Orkla's Acquisition of Da Grasso
MFW Fialek has advised Orkla on the acquisition of shares in the Da Grasso pizzeria chain. NGL Legal advised sellers Karolina Rozwandowicz and Magdalena Pirog.
NGL Legal and CMS Advise on Sale of CDT Medicus to Medicover
NGL Legal has advised the shareholders of CDT Medicus on the sale of their company to Medicover. CMS advised Medicover on the deal.
Starting in Style: Interview with the Partners of the New NGL Symbio Alliance
Interview with the Partners of the New NGL Symbio Alliance.