NANDO – a key base for compliant trade in the EU on the example of the segment of medical devices
Publication date: April 25, 2024
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.
“THE MOST EXPENSIVE PREVENTION IS ALSO CHEAPER THAN THE CHEAPEST TREATMENT” – LEGAL REGULATIONS FOR REPORTING PERFORMANCE TESTS OF A MEDICAL DEVICE FOR IN VITRO DIAGNOSTICS
Publication date: April 17, 2024
Medical devices for in vitro diagnostics.
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;
- to predict response or responses to treatment;
- to determine or monitor therapeutic activities.
15 new medical professions in Poland – from March 26, 2024
Publication date: April 15, 2024
15 new medical professions in Poland – the new act of law entered into force on March 26, 2024. Importantly, work is still underway on the regulation specifying professional activities for individual medical professions, and this is important in the context of employers entrusting the scope of responsibilities to persons performing these new medical professions, such as also the need to ensure the health safety of patients.
New medical professions in Poland – from March 26, 2024.
PLANNED AMENDMENTS TO ABORTION LAW IN POLAND – CONTROVERSIES
Publication date: April 15, 2024
The issue of the right to abortion in Poland is currently a lively topic of political discussions aimed at changing existing regulations in a way that gives women the right to decide about their own body. Currently, attention is focused on four projects (drafts) bringing changes in the analyzed topics:
