Legal opinion in Case T-600/21 WS and Others v Frontex before the Court of Justice of the European Union, commissioned by the applicants' legal counsel.
With the implementation of the new MDR 2017/745 by the European Parliament, more robust clinical and pre-clinical data will be required due to a more stringent approval process. The EFORT Implant... Show moreWith the implementation of the new MDR 2017/745 by the European Parliament, more robust clinical and pre-clinical data will be required due to a more stringent approval process. The EFORT Implant and Patient Safety Initiative WG1 'Introduction of Innovation', combined knowledge of orthopaedic surgeons, research institutes, orthopaedic device manufacturers, patient representatives and regulatory authorities to develop a comprehensive set of recommendations for the introduction of innovations in joint arthroplasty within the boundaries of MDR 2017/745. Recommendations have been developed to address key questions about pre-clinical and clinical requirements for the introduction of new implants and implant-related instrumentation with the participation of a steering group, invited by the EFORT Board in dialogue with representatives from European National Societies and Speciality Societies. Different degrees of novelty and innovation were described and agreed on in relation to when surgeons can start, using implants and implant-related instrumentation routinely. Before any clinical phase of a new implant, following the pre-market clinical investigation or the equivalent device PMCF pathway, it is a common understanding that all appropriate pre-clinical testing (regulatory mandatory and evident state of the art) - which has to be considered for a specific device - has been successfully completed. Once manufacturers receive the CE mark for a medical device, it can be used in patients routinely when a clinical investigation has been conducted to demonstrate the conformity of devices according to MDR Article 62 or full equivalence for the technical, biological and clinical characteristics has been demonstrated (MDR, Annex XIV, Part A, 3.) and a PMCF study has been initiated. Show less
Mechanisms to control public power have been developed and shaped around human beings as decision-makers at the centre of the public administration. However, technology is radically changing how... Show moreMechanisms to control public power have been developed and shaped around human beings as decision-makers at the centre of the public administration. However, technology is radically changing how public administration is organised and reliance on Artificial Intelligence is on the rise across all sectors. While carrying the promise of an increasingly efficient administration, automating (parts of) administrative decision-making processes also poses a challenge to our human-centred systems of control of public power. This article focuses on one of these control mechanisms: the duty to give reasons under EU law, a pillar of administrative law designed to enable individuals to challenge decisions and courts to exercise their powers of review. First, it analyses whether the duty to give reasons can be meaningfully applied when EU bodies rely on AI systems to inform their decisionmaking. Secondly, it examines the added value of secondary law, in particular the data protection rules applicable to EU institutions and the draft EU Artificial Intelligence Act, in complementing and adapting the duty to give reasons to better fulfil its purpose in a (partially) automated administration. This article concludes that the duty to give reasons provides a useful starting point but leaves a number of aspects unclear. While providing important safeguards, neither EU data protection law nor the draft EU Artificial Intelligence Act currently fill these gaps. Show less
Manders, M.; Dissel, A.M.C. van; Brouwers, W.; Fink, M.; Spoelstra, J.; Hoop, R. de; ... ; Vroomen, O. de 2022
Frontex has become one of the major players in European external border management. As its powers and resources have increased, so have the challenges surrounding its compliance with fundamental... Show moreFrontex has become one of the major players in European external border management. As its powers and resources have increased, so have the challenges surrounding its compliance with fundamental rights. A major concern continues to be how to ensure legal accountability for fundamental rights violations that occur in the context of its activities. While Member States can be held accountable before their own national courts and before international courts, neither of these options are available in relation to Frontex. But it can be brought before the Court of Justice of the European Union to account for the conformity of its conduct with EU law. This Article explores the potential of the EU action for damages to offer a remedy for fundamental rights violations committed by Frontex. It identifies where public liability law falls short of providing a remedy for fundamental rights violations committed by EU bodies, explores the possibilities to close that gap, and assesses the implications this has for Frontex’s liability. The Article argues that the action for damages may be the means to close the accountability gap in the specific case of Frontex, but also more generally in circumstances where EU administration is delivered in the form of informal or factual conduct. If it is to fulfill that role, the CJEU would have to lower the threshold for EU liability where fundamental rights are concerned. Show less
Non-governmental organisations (NGOs) have become increasingly involved in search and rescue in the Mediterranean Sea in order to fill a gap in humanitarian protection. This article examines the... Show moreNon-governmental organisations (NGOs) have become increasingly involved in search and rescue in the Mediterranean Sea in order to fill a gap in humanitarian protection. This article examines the legal framework of their search and rescue activities. The international law of the sea sets out an obligation to render assistance to persons in distress at sea. However, recent developments reveal that the relationship between NGO vessels rendering assistance and the affected coastal states is highly uncertain. This article addresses two particular questions: First, can NGOs navigate anywhere in order to render assistance at sea or can (coastal) states limit the rights of navigation of NGOs? Second, can coastal states give NGOs binding instructions concerning whether and how to conduct search and rescue and where to disembark the persons rescued? The article concludes that within their territorial sea, coastal states enjoy the power to determine, in a legally binding manner, how search and rescue operations are carried out, but that they may not deny NGOs access to distress scenes. Beyond their territorial sea, coastal states are neither entitled to issue binding instructions to foreign vessels nor limit their navigational freedom. In any case, all instructions have to comply with the substantive restrictions set out within the Search and Rescue regime and international human rights law. Show less
This thesis examines the legal responsibility for human rights violations that may occur in the context of border control or return operations coordinated by the EU agency Frontex. Imagine,... Show moreThis thesis examines the legal responsibility for human rights violations that may occur in the context of border control or return operations coordinated by the EU agency Frontex. Imagine, for example, that during a border control operation at sea, a vessel forces a boat carrying migrants back to its place of origin, which may be in violation of the rights of persons on that boat. The operation is hosted by State A, coordinated and financed by Frontex, but the vessel in question is from State B. The contributions by State A, B, and by Frontex to the violation vary in nature and degree. But which contribution leads to legal responsibility? The thesis concludes that direct responsibility typically lies with the host state. In addition, participating states who contribute large assets and Frontex will often incur responsibility together with the host state, predominantly on the basis of their obligations to protect or supervise. However, the study also exposes just how difficult it may be for individuals to find a place for bringing complaints against violations of their human rights suffered at the EU’s external borders. This casts doubts on whether the current legal framework offers them an effective remedy. Show less
