produkty: Law of the European Union

Evidence: 100 • authority: 72

European Union law is a system of supranational laws operating within the 27 member states of the European Union (EU). Originally referred to as Community law, it has grown over time since the 1952 founding of the European Coal and Steel Community, to promote peace, social justice, a social market economy with full employment, and environmental protection. The Treaties of the European Union agreed to by member states form its constitutional structure. EU law is interpreted by, and EU case law is created by, the judicial branch, known collectively as the Court of Justice of the European Union. Legal Acts of the EU are created by a variety of EU legislative procedures involving the popularly…

Evidence: 67 • authority: 72

The president of the European Commission, also known as president of the College of Commissioners, is the head of the European Commission, the executive branch of the European Union (EU). The president of the Commission leads a cabinet of commissioners, referred to as the College. The president is empowered to allocate portfolios among, reshuffle, or dismiss commissioners as necessary. The college directs the commission's civil service, sets the policy agenda and determines the legislative proposals it produces. The Commission is the only body that can propose, or draft, bills to become EU laws. The Commission president also represents the EU abroad, together with the High Representative of…

Evidence: 51 • authority: 92

Challenges and Recommendations in Regulating AI Medical Devices in the European Union: A Scoping Review.. Background/Objectives : The integration of artificial intelligence (AI) in medical devices has significant potential for transforming healthcare in the European Union (EU). However, AI medical devices are regulated under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), as well as horizontal legislation such as the AI Act, resulting in a multilayered framework that raises difficulties for all stakeholders. This scoping review aims to identify and classify the challenges associated with the regulation of AI medical devices in the EU and t…

Evidence: 51 • authority: 72

Right to repair is a legal right for owners of devices and equipment to freely maintain, repair, or modify products such as automobiles, electronics, and farm equipment. Common obstacles to repair include requirements to use only the manufacturer's maintenance services, restrictions on access to tools and components, and software barriers. These obstacles represent a repair monopoly, an aftermarket monopoly where a company controls the market for repairing and maintaining their products, making it difficult or even impossible for anyone to fix them. This can take the form of making it challenging or prohibitively expensive for individuals or independent third parties to get access to parts,…