The UK MedTech Forum, of which the Proprietary Association of Great Britain (PAGB) is a member, has written to the Medicines and Healthcare products Regulatory Agency (MHRA) recommending regulatory reforms aimed at improving patient access and supporting innovation in the HealthTech sector. In a letter addressed to MHRA Chief Executive Lawrence Tallon, the Forum called for the indefinite recognition of EU CE-marked medical devices to prevent regulatory duplication, reduce costs, and maintain timely access to safe and effective technologies. It also advocated for the introduction of internationally aligned reliance pathways for premarket approvals, enabling streamlined oversight based on approvals by trusted foreign regulators. Emphasising the need to eliminate systemic barriers and fast-track alternative routes to market, the Forum underlined MHRA’s opportunity to promote global harmonisation through its role in the International Medical Device Regulators Forum (IMDRF). Forum members expressed their ongoing commitment to working with MHRA to co-develop a regulatory framework that improves patient outcomes and strengthens the UK HealthTech ecosystem.

This Practice Note provides high-level information on the UK rules for product governance, which form part of the UK MiFID II regime and apply to the design, approval, marketing and ongoing management of financial products throughout their lifecycle. The MiFID II product governance rules are set out in PROD 2 and PROD 3 in the Financial Conduct Authority’s (FCA’s) Product Intervention and Product Governance sourcebook (PROD). Note that PROD also contains rules on IDD and pathway investments (PROD 4), extended warranties sold with rent-to-own agreements (PROD 5), additional provisions for pathway investments and default options (PROD 6), funeral plans (PROD 7) and products available for targeted support recipients (PROD 8). These rules are not covered in this Practice Note. For general information on the UK MiFID II regime, see Practice Note: UK MiFID II—essentials. Application of PROD 3 PROD 3 sets out the product governance requirements which form part of the UK MiFID II regime and applies to: • MiFID investment firms (ie investment firms with their head offices in the UK)

The Markets in Financial Instruments Directive (Directive 2014/65/EU) (MiFID II) and Markets in Financial Instruments Regulation (Regulation (EU) 600/2014) (MiFIR) (together the MiFID II framework) were published in the Official Journal of the European Union (EU) on 12 June 2014 and came into effect on 3 January 2018. MiFID II and MiFIR were implemented in the UK through amendments to legislation drafted by HM Treasury, as well as Financial Conduct Authority (FCA) and Prudential Regulation Authority (PRA) rules and guidance. For more information on the UK implementation of MiFID II and MiFIR, see Practice Note: UK implementation of MiFID II and MiFIR [Archived]. The EU’s MiFID II framework has recently been the subject of a mandated review process led by the European Commission (the EU MiFID II Review). For information on the development of the Commission’s proposals and the legislation in its final form, see Practice Note: European Commission review of EU MiFID II [Archived]. As a result of the UK’s withdrawal from the EU, the UK was not subject to this review and the resulting

This timeline shows key developments relating to the UK provisions which implemented the recast Markets in Financial Instruments Directive 2014/65/EU (MiFID II) and Assimilated Regulation (EU) 600/2014 (UK MiFIR) (together, the UK's MiFID II framework). For earlier developments, see: Markets in Financial Instruments Directive (MiFID II) and Markets in Financial Instruments Regulation (MiFIR)—timeline (2007–2023) [Archived]. For key developments relating to the EU’s MiFID II framework, see: EU Markets in Financial Instruments Directive (MiFID II) and Markets in Financial Instruments Regulation (MiFIR)—timeline. 2026 Date Source Document Description 3 August 2026 FCA Policy Statement PS26/15: Improving the UK transaction reporting regimeFCA finalises rules to cut firms' transaction reporting costs by over £100m a year The Financial Conduct Authority (FCA) has published Policy Statement PS26/15, Improving the UK transaction reporting regime, setting out final rules to simplify transaction reporting requirements under the UK Markets in Financial Instruments Regulation (UK MiFIR). The FCA says the reforms will reduce firms' compliance costs by more than £100m a year while ensuring it continues to receive high-quality transaction data to support market oversight

This Practice Note provides high-level information on the key elements of the UK MiFID II regime, with links to detailed guidance. The UK MiFID II regime is a body of law and regulation derived from Directive 2014/65/EU (MiFID II), and including EU measures which had direct effect in the UK, formed part of UK assimilated law upon the UK’s withdrawal from the EU, and are subject to revocation under the Financial Services and Markets Act 2023 (FSMA 2023). Measures forming part of UK assimilated law include Assimilated Regulation (EU) 600/2014 (UK MiFIR) and, until its revocation on 23 October 2025, Commission Delegated Assimilated Regulation (EU) 2017/565 (the UK MiFID II Organisational Regulation). For information on the revocation of UK MiFIR and other assimilated law forming part of the UK MiFID II regime, see Practice Note: UK MiFID II reforms. Activities and firms which the UK MiFID II regime applies to Investment services and activities, and ancillary services The UK MiFID II regime applies to investment services and activities and, where relevant, ancillary services (referred to in the Financial Conduct Authority

Retained Regulation (EU) No 600/2014 on markets in financial instruments as it forms part of retained EU law as defined in the EU (Withdrawal) Act 2018.

The UK Mission to the World Trade Organisation (WTO), UN and other international organisations in Geneva announced a £14 million Aid for Trade package at the 14th WTO Ministerial Conference in Yaoundé, Cameroon. The package consists of £13 million in Official Development Assistance, spread across seven initiatives and £1 million transferred to the WTO Fisheries Fund.

Corporate analysis: The government has published its Modern Industrial Strategy along with multiple individual sector plans, which have a headline focus on economic growth and industrial renewal for the UK. What are the implications for corporate law?

MLex: The Financial Ombudsman Service (FOS) is seeking to block Barclays application for judicial review of a key decision on car finance mis-selling, with potential implications for an ongoing Financial Conduct Authority (FCA) probe.

TMT analysis: After the passing of the Online Safety Act 2023 (OSA 2023) in October 2023, Ofcom is continuing the process of implementation, now launching its third consultation on the guidance and codes for the protection of children. Elle Todd, Francesca Paull and Farkhanda Ali of Reed Smith consider the key takeaways.

WRAP launches UK Packaging Pact to transform packaging system

The UK Parliament has progressed the Arbitration Bill [HL] to its next legislative phase. Following its debate at second reading on 29 January 2025, the Bill has been committed to a Committee of the whole House where it will be considered on 11 February 2025.