The Polish Ministry of Health continues legislative work on a new draft law on medical devices. The original draft was presented during the previous term of the Polish Sejm. The law is intended to carry over the solutions of the EU Regulation 2017/745 (MDR Regulation) on medical devices which came into force at the end of May 2021.[1]
Advertising
medical devices
One of the most significant changes
is expected to be the introduction of certain restrictions on the advertising
of medical devices. First of all, advertising of products at fairs,
exhibitions, public presentations or scientific symposiums will be prohibited.
Sales representatives will not have the opportunity to visit physicians to
advertise their product to them. On the other hand, if a person cooperates with
the company and receives benefits from it, he or she will not be able to
recommend and pass on his or her opinion about the medical device to others. On
the other hand, trade catalogs or price lists containing only the trade name
and the price of a medical device are not to be regarded as product advertising.
The condition is, however, that they do not contain information referring to
the characteristics of the medical device or other information with promotional
purposes or leading to an increase in sales. In addition to the general
prohibition on misrepresentation under the MDR, under the Draft, advertising of
a device to the public will not permit the use of images of persons who are or
claim to be members of the medical profession or depict persons presenting a
device in a manner suggesting that they are members of such profession.
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On October 14, 2021 KIELTYKA GLADKOWSKI will take part in a webinar organised by CohnReznick, focused on plans for healthcare services investment.
As deal activity in healthcare services reached an all-time high in 2020 and last year, the suddenness of the COVID-19 pandemic prompted investors and healthcare providers to look to the M&A market in record numbers, the organisers of the webinar will discuss the environment, trends and deals (closed and planned to expand existing and explore new platforms).
As providers continue to adjust their business models and the ways they provide care to their patients, Private Equity and M&A statistics offer tea leaves into how they plan to do that. The panelists will therefore provide insights on investment trends, healthcare company value drivers and opportunities for the sector.
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On 1 December 2021 KIELTYKA GLADKOWSKI will
take part in The WSJ Pro Cybersecurity Executive Forum, sharing practical
perspectives from senior practitioners, policy makers and thought leaders to
help corporate executives make the right decisions.
The Pro Cybersecurity Executive Forum will
dig into case studies, participants will learn practical advice on how to be a
better technology leader beyond the IT department; there will be presented
solutions-focused interviews with experts from a wide range of industries and
roles.
The agenda will include, inter alia, the
case study describing the 2020 attack on SolarWinds and its customers which brought
supply chain attacks to the fore and was the start of a long journey of
remediation and winning back customer trust. That will be described by the
company’s chief executive. Then, cybersecurity chiefs from the industry will discuss
their biggest challenges and how they’re addressing them. The speakers will
also focus on the Biden administration that took office amid a rising tide of
cyberattacks and describe policies of the administration used to stem attacks
and to help protect companies and consumers.
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KIEŁTYKA GŁADKOWSKI KG LEGAL constantly supervises and prepares its lawyers for the specialization in which they provide services for foreign clients. In order to systematize the conceptual grid of very specialized fields of pharma, biology, medicine and life sciences as well as new tech in healthcare KIEŁTYKA GŁADKOWSKI conducts internal consultations to improve the experience of our lawyers specializing in legal assistance for foreign clients from life science and tech sector. As a result of such internal research, KIEŁTYKA GŁADKOWSKI creates and publishes texts on topics related to modern legal problems, but also to explain the basic concepts of specialized life sciences and pharmaceutical fields. In this way, KIEŁTYKA GŁADKOWSKI aims to demonstrate to potential clients within specialized industries that our lawyers are also familiar with specialist terms necessary for a proper understanding of our foreign client’s business and legal needs.
This is
one of those texts. We invite you to read it.
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Małgorzata Kiełtyka
and Jakub Gładkowski of KG LEGAL Kiełtyka Gładkowski took part in a virtual
meeting of the members of Deutsch-Nordischen Juristenvereinigung e.V.
Deutsch-Nordischen Juristenvereinigung e.V is an organization, which goals
are:
- Promotion of
professional education
- Knowledge and understanding of
Nordic law in Germany and of German law in the Nordic Council countries
- Personal and scientific contact
between German-speaking lawyers and lawyers from the member states of the
Nordic Council.
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