Alison Dennis#7438

Alison Dennis

Partner, International Co-Head Life Sciences and Healthcare, Taylor Wessing LLP
Alison co-heads the international Life Sciences and Healthcare group at Taylor Wessing. She works with international life sciences companies to cut through the complexity of EU regulation of medical devices and pharmaceuticals and get their products to market.

In a career of over 20 years, Alison has helped hundreds of life sciences companies manage the range of legal challenges involved in commercialising medical devices and medicinal products. She combines an encyclopaedic knowledge of the EU and UK life sciences regulatory environment with an analytical understanding of strategy and business in the life sciences sector. 

Alison provides sophisticated advice on regulation, compliance and commercialisation, as well as intellectual property transactions. On a number of occasions, she has successfully persuaded regulators and notified bodies to reconsider and ultimately overturn their decisions, allowing her clients to commercialise new products.

Alison supports clients on outright acquisitions and licences, as well as in due diligence for sizeable corporate transactions and listings. She also helps clients navigate the nuances of structuring and negotiating arrangements with various commercial and health care partners within the complex framework of EU regulations, national laws and industry and deontological codes. 

Her clients praise the pragmatism and commercial awareness she brings to every legal challenge and transaction, as well as her bright and personable working style. She is an accomplished leader, having previously built new life sciences practices for two top-tier London law firms.
Contributed to

5

Clinical evaluation and performance evaluation of medical devices in the EU
Clinical evaluation and performance evaluation of medical devices in the EU
Practice notes

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.

Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
Practice notes

This Practice Note provides an overview of Regulation (EU) 2017/745, the Medical Devices Regulation and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation, and the process of placing a device on the EU market.

Post-market surveillance of medical devices in the EU
Post-market surveillance of medical devices in the EU
Practice notes

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 that monitors and records 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.

The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—EUDAMED and economic operators
The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—EUDAMED and economic operators
Practice notes

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.

The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified Bodies
The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified Bodies
Practice notes

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.

Practice Area

Panel

  • Contributing Author

Qualified Year

  • 1996

Experience

  • Taylor Wessing (2020 - Present)
  • Fieldfisher LLP (2008 - 2020)
  • Reed Smith (1996 - 2008)

Membership

  • Chair/vice-chair, legal & compliance committee, Association of British HealthTech Industries (ABHI), since 2013
  • Regulatory Affairs Professional Society (RAPS)
  • The Organisation for Professionals in Regulatory Affairs (TOPRA)

Qualifications

  • LPC, York Law School (1994)
  • Admitted as a solicitor, England & Wales (1996)
  • Masters, Law & Economics (1993)
  • LLB (Hons) European Legal Studies (1992)

Education

  • University of Oxford (1993)
  • University of Bristol (1992)

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