The NANDO (New Approach Notified and Designated Organizations) database is an indispensable tool for every sponsor or investor who wants to legally introduce their products to the European Union market.
NANDO constitutes a list of notified bodies authorized to issue documents confirming compliance with EU regulations. Notified unit is an organization appointed by EU Member State (or other countries under specific agreements) to assess the compliance of certain products with the regulations before placing them on the market. As the name NANDO suggests, it refers to all organizations in the European Union notified and designated by the European Union under the political concept called “New Approach” and “New Approach Framework”. This covers a wide range of products, including toys, personal protective equipment and diagnostic devices.
KIEŁTYKA GŁADKOWSKI lawyers from the Polish jurisdiction took part in the inaugural meeting of INSOL SPG. INSOL is an international legal organization associating lawyers and accounting and financial advisors specializing in bankruptcy and restructuring matters, especially those with a cross-border element. KIELTYKA GLADKOWSKI lawyers are members of INSOL INTERNATIONAL. During the meeting, comparative issues of debt collection in individual jurisdictions and the need to regularly inform colleagues about legislative changes, including corporate and consumer bankruptcy, were discussed.
The subject of the meeting was to prepare practical issues for the annual conference in San Diego (USA) from May 22 to 24, 2024 and the possibility of publishing case content on the INSOL newsletter.
Upon the application of Ceneo, the Polish Regional Court in Warsaw banned the Google search engine from favoring its own price comparison website in search results.
The court’s decision applies to the results displayed to users of the Google search engine in Poland. It was issued as security for Ceneo’s claims to refrain from acts of unfair competition before filing a lawsuit against Google.
Ceneo – a comparison website owned by the Allegro Group, the owner of the e-commerce platform – in its application for granting interim security measure (reference number of the case: XXII GWO 24/24) pointed to four types of Google practices that limit their access to the market. The first is favoring one’s own comparison website (Google Shopping) at the expense of competing services (so-called self-preference), done through the way search results are presented. The second – redirecting traffic to Google Shopping at the expense of Ceneo, and the third – hindering access to the Polish comparison website by deleting search results leading to it.
In vitro diagnostic medical devices are intended for testing samples taken from the human body. This test is carried out outside the human body (in vitro) in laboratory conditions, as well as at home, in the case of products intended for self-testing. In accordance with the definition contained in Art. 2 point 2 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ EU, L. of 2017, No. 117, p. 176, as amended) (hereinafter: IVDR) medical device is a device that is a reagent, reagent product, calibrator, control material, kit, tool, instrument, hardware, software or system, whether used individually or in combination, intended by the manufacturer to be used in vitro for the examination of samples obtained from the human body, including blood and tissue obtained from donors, solely or principally for the purpose of providing information:
about a process, physiological or disease state;
congenital physical or mental developmental defect;
predisposition to disease or illness;
to determine safety and compatibility with potential recipients;
