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EU law on medical devices: New transition periods and other changes
Amendments to the EU’s provisions on medical devices were published in the Official Journal on 9 July 2024. The new rules will begin to apply six months after publication (i.e. from 10 January 2025). In vitro diagnostic devices are gaining extended certificate validity and longer transition periods. The EUDAMED database can be launched in steps, which should speed up the mandatory use of the modules that are now ready. Meanwhile, manufacturers and other participants in the distribution chain have a new obligation to report problems with availability of medical devices.
Not all public assistance is state aid
Granting of state support in the EU, which businesses are increasingly taking advantage of, is based on a set of common principles. Mainly these include compatibility with the internal market, achievement of an objective of common interest, a clear incentive effect, proportionality, and full transparency. Violation of these rules when granting public support may mean a grant of unlawful state aid, incompatible with the common market and subject to recovery.
Deregulated public procurement
A proposal to cut red tape for businesses in Poland could backfire against contractors in procurement appeals.
News from Poland—Business & Law, Episode 46: NIS2 EU Directive: Why should management be responsible for cybersecurity?
The newest episode of News from Poland is devoted to the topic of personal responsibility of management bodies for compliance with cybersecurity regulations and standards, particularly with the EU NIS2 Directive and its upcoming transposal to Polish law.
The subject is explained by Jakub Barański, adwokat and partner from the firm's Dispute Resolution Practice.
The subject is explained by Jakub Barański, adwokat and partner from the firm's Dispute Resolution Practice.
Fashion in video games
The growing role of fashion in the world of video games was confirmed by the Roblox report published in November 2023 analysing the behaviour of Gen Z. The survey found that for 84% of respondents, digital fashion is an important part of the game, with 56% of respondents admitting that their avatar’s appearance is just as important to them as their own real-life appearance—up from 42% the year before.
Tales from the National Appeal Chamber: Requiring additional evidence is an unreasonable barrier to fee indexation
The last two years in the public procurement market have been stormy. The Covid-19 pandemic and the war in Ukraine have caused a steady and dynamic increase in the prices of materials and services, and disrupted supply chains, translating into record inflation rates and unprecedented fee increases. With this tough economic situation directly affecting the market, contractors have faced the difficult task of indexing their fees in public contracts. The National Appeal Chamber, which hears challenges in public procurement matters in Poland, gave essential guidance on this issue in its ruling of 28 November 2023 (case no. KIO 3389/23).
Control of foreign investments in Poland: The competition authority’s current procedural guidance
On 9 May 2024, the Office of Competition and Consumer Protection (UOKiK) published updated guidance on notifications to the regulator and conducting proceedings under the Control of Certain Foreign Investments Act. The amended provisions of the act, which significantly expanded the scope of its application, entered into force almost four years ago, in July 2020. At that time, the regulator was granted additional powers to protect Polish companies deemed vital for public order, security or health (as we discussed in the article “Control of certain investments: new protective provisions”). The regulator published its first guidance on the new rules in 2022.
Progress on the Polish National Recovery Plan and amendments to state aid law
On 3 May 2024, Poland marked the third anniversary of submission of the first version of its National Recovery Plan to the European Commission. On the eve of that date, information was released on disbursement of the first funds under the plan, in the amount of c. EUR 6.3 billion. But this is not the only good news for those interested in financial support from European funds. Legislative work is also underway to help absorb funds the National Recovery Plan and other European funds.
News from Poland—Business & Law: tax offence at a company – who’s liable for the crime?
The newest episode of News from Poland is about who may be held liable for tax offences committed at a company. The issue is explained by Jakub Znamierowski, PhD, adwokat and senior associate in the firm's Criminal Law Practice.
Insurers of trade receivables should verify whether their outsourcing of collections complies with KNF guidance
Guidance from the Polish Financial Supervisory Authority of 25 March 2024 on certain aspects of outsourcing by insurers and reinsurers also covers collection proceedings related to performance of insurance contracts. Insurers offering trade credit for which collections are carried out by external providers must verify whether this outsourcing is compliant with the regulator’s position.
