Taylor Wessing LLP

This Practice Note discusses key changes to the requisite clinical evaluation and performance evaluation processes of medical devices under the EU regulatory regime introduced by Regulation (EU) 2017/745, the Medical Devices Regulation (MDR) and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR). This note considers the practical implications of the changes to definitions and requirements for clinical data, clinical evidence and, in particular, clinical investigations for assessing the health and safety of medical devices under the MDR and IVDR in Europe.

This Practice Note discusses the various intellectual property (IP) rights that can be used in relation to personalised medicines. It explains what personalised medicines are and how they are identified. It explores second and subsequent medical use claims, sub-population claims, as well as monoclonal antibody patents. It examines the plausibility threshold for inventive step and sufficiency, and plausibility and enablement of functional claims. It also discusses patentability of diagnostic products and methods and supplementary protection certificates (SPCs) for targeted treatments. This Practice Note also covers other IP considerations, such as regulatory data protection and market exclusivity, the protection of trade secret as well as copyright and database rights.

This Practice Note provides an overview of Regulation (EU) 2017/745, the Medical Devices Regulation (MDR) and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR), and the process of placing a device on the EU market, including the application of complex transitional provisions for ‘legacy’ devices certified under the previous directives regime.

This Practice Note examines the EU regulatory regime introduced by Regulation (EU) 2017/745, the Medical Devices Regulation (MDR) and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR), in relation to its reform and strengthening of a mandatory comprehensive post-market surveillance system and vigilance obligations that monitor and record the real-life use of medical devices after authorisation to feedback into a device’s official safety profile and certification, thereby ensuring their continuing safety. Stakeholders involved in the supply chain of devices must implement robust interrelated systems and maintain a significant paper trail. This Practice Note discusses details of the compliance requirements, such as preparing the periodic safety update report (PSUR) and other reporting obligations involved.

This Practice Note written by Alison Cartin, of Taylor Wessing LLP explains the role of the protector of a trust, the reasons why a settlor might choose to appoint a protector and the powers and liabilities of a protector. It also explains how to appoint a protector and issues to consider when drafting a trust with a protector.

This Practice Note, produced in partnership with James Ross of Taylor Wessing, provides an overview of some of the tax issues that are particularly relevant to a company operating in the life sciences sector. Such companies may include pharmaceutical, medical technology, biotechnology companies etc. In particular, it considers, among other things, corporation tax issues such as R&D reliefs and the patent box; cross-border issues such as transfer pricing and investment reliefs.

This Practice Note considers the European database on medical devices (EUDAMED) and the obligations of economic operators, such as manufacturers, distributors and importers of medical devices, under Regulation (EU) 2017/745, the Medical Devices Regulation and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation.

This Practice Note examines the scope and classification of devices under Regulation (EU) 2017/745, the Medical Devices Regulation and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation, conformity assessment procedures and designation and monitoring of Notified Bodies.

This Practice Note, written by Alison Cartin of Taylor Wessing LLP, provides an overview of the remittance rules affecting UK resident non-domiciled individuals (non-doms). It considers what is and what is not a remittance, the extension of the remittance basis of taxation to temporary non-residents eligibility for the remittance basis, how to claim the remittance basis and the possible drawbacks of doing so. It includes references to Finance Act 2012.

This Practice Note, written by Alison Cartin of Taylor Wessing LLP, covers mixed funds for the purpose of the remittance basis. It considers: the statutory definition of ‘mixed fund’ under section 809Q(6) of the Income Tax Act 2007; when a transfer from a mixed fund will occur; and the steps for ascertaining the composition of a remittance (arising by virtue of Conditions A and B) from a mixed fund.

This Practice Note sets out the UK tax considerations for an innovative business with global ambition when developing and acquiring IP. Specifically, it focuses upon the intangible fixed assets regime, R&D reliefs and the UK patent box. This Practice Note was produced in partnership with Graham Samuel-Gibbon and Claire Hawley of Taylor Wessing.

This Practice Note sets out some of the UK tax considerations for an innovative business with international or global ambition looking to structure its exploitation of IP. The UK tax treatment of IP-derived profits falling both inside and outside of the UK patent box is considered, as is the possibility of realising such profits outside the UK and the associated CFC risks. The VAT considerations are also briefly outlined. This Practice Note was produced in partnership with Graham Samuel-Gibbon and Michelle Williamson of Taylor Wessing.