Europarättslig tidskrift nr 4 2023
ISSN (ONLINE): 2002-3561
LEDARARTIKEL
ARTIKLAR
Peer Review
Liability for Medical Devices – How Clear and Harmonised Is It?
Civil liability for defective medical devices is not regulated comprehensively by European Union (EU) law. The current EU product liability rules cover a significant proportion of the cases that concern the liability of manufacturers, but the national laws of EU Member States remain relevant. The liability of parties other than manufacturers is largely left to national laws. Given the vagueness of EU law, case outcomes vary, and the law is uncertain. Economic operators need clear liability rules to gauge the risks of introducing innovations to the market. Predictable liability rules are also important for individuals and for the uptake of new technologies. At present, interpreting EU and national law can be difficult, in particular in the context of intelligent medical devices. EU legislators are eager to promote the use of beneficial artificial intelligence (AI). Accordingly, they have published two proposals that, if passed into law, would affect liability for medical devices. One of the proposals concerns a revision of the EU product liability framework. The other deals with damages liability for harm caused by AI. In this article, we address the problems of contemporary EU law and discuss developments in the Union-level regulation of liability for medical devices.
Peer Review
The Choice of Legal Basis in EU Competition Law: Shifting the Competence in the Digital Era
This article analyses the competence shift in EU competition law, with a particular focus on the digital era and the EU’s institutional dimension. As will be argued, the latter is expanding by means of new legislation in the Digital Single Market. Particularly Article 114 TFEU is employed as a legal base for this purpose, which essentially harmonises and pre-empts Member States’ action in this area. The article argues that the Commission’s preference of Article 114 TFEU over Article 103 TFEU significantly alters the constitutional setup of competences in the area of competition law as codified by the Treaty of Lisbon. This is further exacerbated by the new ex-ante mechanism as opposed to the traditional ex-post framework. In addition and with regards to judicial review, the courts have often interpreted general criteria of legal basis litigation in favour of the EU institutions and thereby increased and legally manifested their powers vis-à-vis the Member States. The article concludes by arguing that regulation and centralisation in the Digital Single Market not only increases the EU’s institutional dimension, but also serves as a proxy for treaty change.
Peer Review
Nya regler om invasiva främmande arter: Hur försiktigt blev det?
Caroline Gardelli, Maria Pettersson
Invasiva främmande arter utgör ett av de största hoten mot biologisk mångfald. År 2015 trädde en EU-förordning om förebyggande och hantering av introduktion och spridning av invasiva främmande arter i kraft, och Sverige har därefter infört reglering i form av lagändringar i miljöbalken år 2018 samt genom antagandet av en svensk förordning år 2019. I artikeln redogörs för den EU-rättsliga och den svenska regleringen mot bakgrund av världshandelsorganisationens regler om sanitära och fytosanitära åtgärder och analyseras huruvida den nya regleringen förändrat möjligheterna att vidta åtgärder mot invasiva främmande arter med stöd av miljöbalkens försiktighetsprincip. Vidare undersöks om regleringen innebär att svenska myndigheter fått bättre förutsättningar att arbeta med invasiva främmande arter, och diskuteras vad som ytterligare kan behövas för att arbetet ska bedrivas effektivt.
