Category: 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:

• concern medical devices intended for use by non-laymen,
• be worded in a way that is hard to understand by a layman (this also applies to medical and scientific wording, opinions, literature or scientific studies and other material aimed at professionals),
• use the image of persons practising or claiming to practise a medical profession or depict persons presenting a device in a manner suggesting that, and
• be directed at children.

The draft regulation of the Minister of Health on the medical device advertising provides for further restrictions and requirements applying to advertising to the public.

Problem with the qualification of the medical devices for users other than laymen

Because of the variety of medical devices available on the market and their practical use, it can in some situations be difficult to establish if the specific device is or is not intended for the use by the non-laymen. As a result, it can be hard to determine what restrictions in advertising of such devices in fact apply.

In the absence of more precise guidelines, the evaluation will always need to be made on a case-by-case basis. The legislator’s intention behind the MDA was, in case of doubts, to follow the previous decisions of the regulatory authorities and courts for medicines. In practice, adopting a very strict approach could not only significantly limit advertising activities in the medical device sector, but also make it more difficult for patients to access information about possible therapeutic options, including new and innovative medical devices. Such approach may not always respond properly to the needs of the market and the patients.

Problem with assessing whether an advertisement is directed to the public

When assessing whether an advertisement is directed to the public, it is necessary to take into account not only the intentions of the advertiser, but also the actual availability of the message.

With respect to medicines, the competent authorities considered situations in which an advertisement intended to be directed to professionals accidentally reached the laymen as advertising directed to the public (e.g. patients being able to read leaflets at the doctor’s office or the availability to the postman of an envelope with the medicine’s logo). The time will tell what the actual practice of the regulatory authorities in fact is with respect to medical devices.

In online advertising of medical devices addressed to professionals, care will need to be taken to ensure that access to the advertisement is appropriately secured (e.g. a login requirement for registered professional users).

By Agnieszka Majka, Partner, Celina Bujalska, Senior Associate, and Paulina Roslon-Horosz, Junior Associate, NGL Legal

Clifford Chance has advised ING Bank Slaski, Bank Gospodarstwa Krajowego, and Alior Bank on a sustainability-linked corporate refinancing for the Paged Group. Baker McKenzie advised the borrowers.

According to Baker McKenzie, the funding is aimed at refinancing Paged Group’s existing debt and obtaining financing for the group’s general corporate purposes in the form of multi-million euro and zloty term and revolving facilities.

The Paged Group is a Polish plywood and bentwood furniture producer. The company also produces plywood in Estonia through its subsidiary Paged Eesti.

The Clifford Chance team was led by Partner Andrzej Stosio and Counsel Kacper Bardan and included Associates Piotr Weclawowicz, Artur Gladysz, Krzysztof Burda, Aleksander Smakosz, and Aleksandra Sierac.

The Baker McKenzie team was led by Partner Marcin Iwaniszyn and included Senior Associate Sebastian Mikina and Lawyers Andrzej Sarnacki, Krystian Kurgan, and Oskar Lipien.

GFKK Grzybczyk Kaminski Gawlik has advised German company IAV on entering the Polish market to operate as IAV Poland Spolka.

IAV, with its registered office in Berlin, is a part of the IAV international group, specializing in the automotive engineering industry. The company employs over 7,500 people in Germany and countries including China, Japan, and the US.

The GFKK team included Partner Michal Grzybczyk, Attorney-at-Law Marek Widera, and Lawyer Agata Piotrowska.

Marszalek & Partnerzy has advised Dom Development on its PLN 90 million sale of a property to an institutional investor in the private rental sector as well as the conclusion of a contract to build four residential buildings worth PLN 200.4 million.

Dom Development is Warsaw Stock Exchange-listed real estate developer.

The Marszalek & Partnerzy team included Partners Piotr Marszalek and Iwona Dobkowska-Pulawska and Associate Magdalena Mydlowska.

Marszalek & Partnerzy did not respond to our inquiry on the matter.

CDZ Chajec & Partners has advised Centerscape Poland on its acquisition of five retail parks located in Warsaw, Lodz, Bydgoszcz, Jablonna, and Lewin Brzeski with a total retail area of 10,000 square meters.

Centerscape Poland is a retail properties investor, developer, owner, and manager in Poland, Germany, and the Czech Republic.

The CDZ team was led by Partner Patryk Galicki and included Lawyers Nina Horbowiec, Jakub Urbanek, Agnieszka Wisla, and Szymon Zyto.

CDZ did not respond to our inquiry on the matter.

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.

According to Article 7 of the MDR or the IVDR, it is prohibited to use in the advertising of devices text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device’s intended purpose, safety and performance by:

• ascribing functions and properties to the device which the device does not have,
• creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have,
• failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose,
• suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

In addition, the Polish Medical Devices Act of 7 April 2022 (the MDA; Article 55(3)) stipulates that medical device advertising cannot be misleading as to the conditions of maintenance, servicing, software updates, inspections, adjustments, calibrations, and safety checks, including the requirements for technical equipment, entities performing these activities and their qualifications.
In practice, advertising can be regarded misleading not only if it contains false information, but also if it provides information that is incomplete, unclear, hardly verifiable or difficult to access (even if it is objectively true). Advertising can also be considered misleading if it creates perception of the device inconsistent with the real state of affairs, contains generalizations, presents the device in a biased view, or guarantees effect.
Additionally, not only advertising, but also other types of communication about medical devices need to comply with applicable laws.

Sanctions for violations of Article 7 of the MDR/IVDR

Conducting misleading advertising in breach of Article 7 of the MDR or the IVDR, or Article 55(3) of the MDA is punishable by a fine of up to PLN 2 million (approx. EUR 444,000). Anyone who advertises medical devices in breach of these regulations can be sanctioned.
Breaches of Article 7 of the MDR or the IVDR other than those related to the advertisement are subject to financial penalty of up to PLN 5 million (approx. EUR 1.1 million).

By Agnieszka Majka, Partner, Celina Bujalska, Senior Associate, and Paulina Roslon-Horosz, Junior Associate, NGL Legal

WKB Partners Agnieszka Wiercinska-Kruzewska and Aleksander Stawicki have been appointed as the new Managing Partners of WKB, taking over the role from Partner Jerzy Baehr.

“I am very pleased to be handing over the management of WKB to the next generation of equity partners,” commented Baehr. “I took over the reins from Andrzej Wiercinski. The law firm can grow if it is propelled by the energy of many people with different experiences and predispositions. Agnieszka and Alexander have been involved with WKB from the beginning, both having built large, market-leading practices. Now, with the participation of other equity partners, they will have a chance to apply their unique experience in their new role.”

Wiercinska-Kruzewska is WKB’s Co-Founding Partner and the firm’s Head of Intellectual Property and TMT. Before founding WKB in 2004, she spent seven years with Wardynski & Partners.

Stawicki is the Head of the firm’s Competition Law and Consumer Law practice. He has been with the firm since 2008 and became Senior Partner in 2015. Stawicki graduated from Adam Mickiewicz University and holds an LLM degree from Radboud.

“Jerzy’s tenure has been a very good time for WKB,” Wiercinska-Kruzewska said. “We are very grateful indeed to Jerzy for the effort he has put into managing WKB and very much look forward to his ongoing commitment and support.”

“We are taking over the management of WKB recognizing the many areas where we can still grow,” Stawicki added. “We will do our best to fulfill our functions in such a way that we can proudly pass the baton to our successors in a few years.”

Clifford Chance has advised Xebia on the acquisition of GetInData. DLA Piper advised GetInData.

Xebia is an IT consultancy company that operates in the US, India, the Netherlands, Belgium, Germany, Denmark, Dubai, the UK, Poland, Spain, Switzerland, Canada, Mexico, Vietnam, Singapore, Australia, and Colombia. The group is owned by Dutch independent private equity fund Waterland.

GetInData is a Polish company producing big data, cloud, analytics, and ML/AI solutions.

Clifford Chance’s team included Counsel Tomasz Derda, Senior Associates Aleksandra Wlaszczuk and Aleksandra Ulatowska, and Associates Mariusz Wisniewski, Marcelina Slugocka, Katarzyna Kuchta, Agata Parys, and Julia Piotrkowicz.

DLA Piper’s team included Partners Lukasz Dynysiuk and Jakub Domalik-Plakwicz, Senior Associates Malgorzata Krok, Rafal Dostatni, and Michal Banasiak, and Associate Karolina Pichit.

Brockhuis Jurczak Prusak Sroka Nilsson has advised DB Schenker on the construction of its Szczecin transshipment terminal.

According to BSJP, “DB Schenker opened a new transshipment terminal in Szczecin at the end of 2022. The terminal covers an area of approximately 620 square meters and operates 45 docks. The investment is worth tens of millions of Polish zlotys and constitutes an element of DB Schenker’s continuous terminal network optimization program.”

DB Schenker is a Germay-based international logistics company.

The BSJP team included Partner Jaroslaw Sroka, Senior Associate Agnieszka Pokora, and Associate Andrzej Malinowski.

BSJP did not respond to our inquiry on the matter.

Partner Krzysztof Szczecina has been elevated to Equity Partner with Drzewiecki Tomaszek & Partners on January 1, 2023.

Szczecina specializes in corporate/M&A, litigation/disputes, and intellectual property law and has been with Drzewiecki Tomaszek & Partners for over eight years. He joined the firm in 2015 as a Senior Associate and was promoted to Partner in 2017. Before joining the firm, Szczecina was an Associate at Gozlinska, Staszewska-Lisiak & Partners from 2011 to 2015.

“I would like to thank all my clients, colleagues, and everyone else who supported me along the way,” Szczecina commented.