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NEWS
The European Commission’s Medical Device Coordination Group (MDCG) on 8 July 2024 has issued a revision to its guidance to help classify in vitro diagnostic (IVD) devices before they are placed on the market. The updated guidance replaces the former update on 10 February 2023 and is the third revision following its much anticipated release in 2020. The updated guidance explains that conformity assessments are 'highly dependent' on the IVD risk class. It explains the IVDR classification rules, gives examples of the classification categories for certain IVDs, and provides a list of seven rules for classifying IVDs. Some of the changes include the addition of a definition of a kit, which is defined as 'a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof'. It also includes revisions of an example in Rule 3(a) covering devices for detecting the presence of a sexually transmitted agent, a revision of Rule 4(a) covering devices intended for self-testing, a revised Rule 5(c) covering specimen receptacles, and a revised example of a Class B device under Rule 6.
GLOSSARY
NDA guidance, ‘Authority’s Guidance for Site Stakeholder Groups', Ref LAR3.0, 27 March 2009.
NEWS
The European Data Protection Board (EDPB) has provided updated guidance clarifying the rules for data transfers to authorities in third countries. This includes scenarios where such transfers are governed by appropriate safeguards under EU General Data Protection Regulation, Regulation (EU) 2016/679 (EU GDPR), such as standard contractual clauses or binding corporate rules. The guidance aims to ensure compliance with GDPR requirements and the Court of Justice of the European Union’s Schrems II judgment, which highlighted the need for robust protections against indiscriminate access to personal data in third countries. The guidelines are subject to public consultation until 27 January 2025.
NEWS
The President of the Family Division, Sir Andrew McFarlane, has issued guidance for designated family judges engaging with the media in the transparency reporting pilot courts. Journalists have been permitted to attend and observe hearings since 2009 but were previously unable to report without the court’s permission. Pursuant to the transparency reporting pilot in the Family Court established by the President’s Transparency Implementation Group (TIG) in January 2023, journalists and legal bloggers have attended the pilot courts and reported anonymously on cases they have heard there. The President’s guidance is not intended to set out the detailed provisions established in statute and case law as to what aspects of family court proceedings may and may not be reported. The guidance covers practical considerations such as listing, who can attend and who can report, transparency orders, direct contact from journalists and liaison with the local media.
PRACTICE NOTES
This Practice Note explains the Lady Chief Justice's Live Links in Criminal Courts Guidance 2026 (Live Links Guidance), which sets out a presumptive framework for remote attendance in the magistrates’ courts and the Crown Court. The Live Links Guidance must be read in conjunction with the Criminal Justice Act 2003 (CJA 2003), the Criminal Procedure Rules 2025 (CrimPR 2025), SI 2025/909, the Criminal Practice Directions (CPD), the Better Case Management Revival Handbook and Appendix E of the Equal Treatment Bench Book. The Practice Direction on Listing in the Criminal Courts requires the Live Links Guidance to be followed. The Live Links Guidance applies to proceedings in the magistrates’ court and Crown Court. It does not apply to the Single Justice Procedure in the magistrates’ court or proceedings in the Court of Appeal (Criminal Division). For more information on remote hearings, including the statutory framework, see Practice Note: Remote hearings in the criminal courts. The presumptive framework The Live Links Guidance introduces a presumptive framework for the use of live links in criminal
PRACTICE NOTES
This Practice Note provides guidance for mentees, including what it takes to be a good mentee and whether mentoring is the right choice for you. For further guidance on mentoring generally, see Practice Note: Mentoring—getting started. Do I really need a mentor? What can mentees hope to gain from the mentoring relationship? Aside from a valuable ally within the business and an insight into what it means to operate at the most senior levels, you should also be able to get the following from a mentoring relationship: • expert guidance • sound advice • encouragement • a critical friend who will tell you the things you need to hear • a chance to talk through professional concerns • increased self-awareness • career development Mentoring schemes can also provide ongoing support, advice and feedback on work. This approach can help you actively assess your learning and development (L&D) needs and obtain knowledge, advice and expertise to help you meet Solicitors Regulation Authority (SRA) requirements under the SRA competence regime—for further information, see Practice Note: The continuing
PRACTICE NOTES
Knowledge management and personal development are hot topics for most organisations and mentoring is a great way to combine the two. For background guidance on what mentoring is and how to get started, see Practice Note: Mentoring—getting started. Becoming a mentor can be daunting, especially if it is your first time. In this Practice Note, we consider: • the benefits of being a mentor • what skills and experience you will need to be a mentor • how to guide the discussion • what to do if things start to go wrong Benefits of being a mentor Becoming a mentor is not just a 'nice thing to do'. It can have a positive impact on your personal development and future career. Typical benefits include: • reinforcing and refreshing your knowledge and developing soft skills required to meet Solicitors Regulation Authority (SRA) requirements under the SRA competence regime—for further information, see: Practice Note: The continuing competence regime • improving your coaching and development skills—knowing how to do something and enabling someone else to
NEWS
Private Client analysis: Claire van Overdijk, barrister at Outer Temple Chambers, explains the recent case of in which the court set down guidance for trust corporations that apply to the Court of Protection for appointment as property and affairs deputy for incapacitated persons. .
GLOSSARY
The Pensions Regulator produces guidance to help improve understanding of work-based pension schemes and to promote good practice.
NEWS
Employment analysis: The Inner House rejected a petition brought by a feminist organisation, that guidance issued by the Scottish Ministers with respect to the Gender Representation on Public Boards (Scotland) Act 2018 (GRPB(S)A 2018), such that those having transitioned from male to female and holding a full gender recognition certificate would come within the protections of GRPB(S)A 2018, was unlawful. The court held that there was no distinction within the terms of the Gender Recognition Act 2004 (GRA 2004) as between sex and gender, and such an interpretation would not lead to, as the petitioner submitted, contradictions within the Equality Act 2010 (EqA 2010). Therefore, those holding a full gender recognition certificate would benefit both from the protections of the characteristic of gender reassignment, and the characteristic of their acquired sex, under EqA 2010, ss 7 and 11 respectively, and under GRPB(S)A 2018. The petition was consequentially dismissed. Written by Thomas Mallon, barrister at Henderson Chambers.
NEWS
The Home Office has published guidance which sets out how people who were evacuated from Kabul in Afghanistan under Pathway 1 of the Afghan citizens resettlement scheme (ACRS) can make a referral to bring their family member to the UK to settle permanently. This route has opened a long time after the evacuation took place and referrals can only be made until 30 October 2024.