Medical devices regulation – applicable from 26 May 2021

Amidst much anticipation, the Medical Devices Regulation becomes fully applicable across the EU from today, 26 May 2021. These Regulations represent a long-awaited strengthening of the European regulatory system for medical devices.

Related briefings

Virtual Asset Service Providers become subject to registration requirements and AML/CTF obligations

On 23 April 2021, provisions of the Fifth Anti-Money Laundering Directive (5AMLD) were transposed into Irish Law by the Criminal Justice (Money Laundering and Terrorist Financing) (Amendment) Act 2021 (CJA 2021), which amends the Criminal Justice (Money Laundering and Terrorist Financing) Act 2010 (CJA 2010). Please see our recent briefing for analysis of changes introduced by 5AMLD: New Irish Anti-Money Laundering Rules.

Newcastle United FC and the “reasonable bystander” test

Newcastle United Football Club (Newcastle) recently applied to remove the chair of the arbitration panel due to consider the Premier League’s rejection of a proposed takeover of the club. The English High Court (Court) ruled that Michael Beloff QC could continue in his role, as Newcastle’s allegation of bias did not meet the “reasonable bystander” test.

SFDR Level 2 – 7 Months To Go

1 January 2022 is the next key compliance deadline for funds and fund managers under the EU Sustainable Finance Disclosures Regulation (SFDR). It is also the scheduled effective date of SFDR Level 2 measures, a complex and prescriptive set of technical compliance standards (currently at various stages of finalisation) for SFDR. To support compliance preparations, […]

Impecunious plaintiffs and security for costs – a new leg to the test

The Irish Supreme Court recently refined the legal test to be applied in security for costs applications against corporate plaintiffs. The Supreme Court introduced a new leg to the proper approach to such applications. In certain circumstances, the court must consider whether is it likely that the proceedings will be “stifled” by an order for security. This consideration should be taken into account in assessing the rights of the parties and the approach that will cause the least injustice to them.

High Court delivers ruling in Facebook data transfer case

On 14 May 2021, the High Court delivered its ruling in the latest Schrems-related action in which Facebook challenged the legality of the Data Protection Commission (DPC) decision to investigate the transfer by Facebook of EU individuals’ personal data to the US. The High Court has rejected Facebook’s challenge thus paving the way for the DPC investigation to proceed.

Latest Briefings

Principles applicable to an ‘insolvent’ trust in Jersey

It is important that trustees understand their obligations if their trust structure comes under financial stress. Helpfully, the Jersey courts have provided guidance on the principles applicable to ‘insolvent’ trusts, which is likely to be highly persuasive in other jurisdictions.

Flexibility and teleworking

Flexible working is not a new concept in the UK, and it exists in a number of forms, both formal and informal.

The economic substance requirements for Jersey partnerships

The Taxation (Partnerships – Economic Substance) (Jersey) Law 202- was lodged with the States Assembly on 18 May 2021 and, if passed, is expected to come into effect from 1 July 2021 (with a six month transition period to 1 January 2022 for partnerships established before 1 July 2021).


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