Life Sciences

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.

Gessel and Jonak i Partnerzy Advise on Pure Biologics Public and Private Offerings

Gessel has advised Pure Biologics on its public offering of shares carried out under an accelerated book-building program and the private offering of new company shares. Jonak i Partnerzy advised the managers.

Closing: INVL Baltic Sea Growth Fund Acquisition of Nemunas and Egles Sanatorija Now Closed

On December 29, 2022, Sorainen announced that INVL Baltic Sea Growth Fund’s acquisition of Nemunas and Egles Sanatorija (reported by CEE Legal Matters on June 13, 2022) had closed.

Dorda and Schoenherr Advise on Croma-Pharma and EHC Business Combination Agreement

Dorda, working with Loyens & Loeff, has advised Croma-Pharma on entering into a business combination agreement with the European Healthcare Acquisition & Growth Company. Schoenherr, working with Sullivan & Cromwell and Houthoff, advised EHC.

D&B David si Baias Advises Memorial Healthcare on Acquisition of Monza Oncology Hospital

PwC Legal Romanian affiliate D&B David si Baias has advised Memorial Healthcare on its acquisition of the Monza Oncology Hospital within the Enayati Medical City in Bucharest.

Deal 5: MediGroup Director Mihailo Obucina on Acquisition of Konzilijum

On December 8, CEE Legal Matters reported that BDK Advokati had advised MediGroup on its acquisition of Konzilijum. CEE In-House Matters spoke with Mihailo Obucina, Director of Strategy, M&A, and Business Development at MediGroup, to learn more about the acquisition.