Alison Dennis
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.
Practice Areas
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)
5 Contributions by Alison Dennis
PRACTICE NOTES
EU MDR/IVDR clinical and performance evaluation of medical devices and IVDs: clinical investigations, evidence standards, risk management and post-market obligations
Practice Note
This Practice Note sets out the principal updates to the mandatory clinical evaluation and performance evaluation pathways for medical devices under the EU regime brought in by Regulation (EU) 2017/745 (the Medical Devices Regulation, MDR) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation, IVDR), together termed the MD Regulations. The MD Regulations represent a substantial shift in how the health and safety of devices are appraised, requiring a structured, rigorously evidenced clinical/performance evaluation that starts with the conformity process (CE marking) and carries on throughout the entire life cycle of a device. This Practice Note examines the practical consequences of the revised definitions and obligations for clinical data, clinical evidence and, notably, clinical investigations.
For further information on:
an introduction to the MD Regulations, see Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
scope and classification of devices, conformity assessment procedures and Notified Bodies, see Practice Note: The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified Bodies
post-market surveillance, see Practice Note: Post-market surveillance of medical devices in the EU
European database on...
Life Sciences
PRACTICE NOTES
EU MDR/IVDR EUDAMED and UDI: compliance obligations for manufacturers, authorised representatives, importers and distributors, with roll-out timelines and transitional guidance
This Practice Note explores the European database on medical devices (EUDAMED) and the obligations on economic operators, including manufacturers, distributors and importers of medical devices, arising under Regulation (EU) 2017/745, the Medical Devices Regulation (MDR), and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR). For guidance on:
key provisions of the MDR and IVDR, refer to Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
scope and classification of devices, conformity assessment procedures and Notified Bodies, see Practice Note: The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified Bodies
clinical evaluation and investigation of devices, consult Practice Note: Clinical evaluation and performance evaluation of medical devices in the EU
post-market surveillance, see Practice Note: Post-market surveillance of medical devices in the EU
EUDAMED and UDI system
The European Commission has been tasked with upgrading Eudamed2, the database created under the MD Directives regime, to encompass information about all devices and about their manufacturers, importers and authorised representatives. The initial plan was for EUDAMED to be accessible for use, even if not fully operational, from the date of application of...
Life Sciences
PRACTICE NOTES
EU MDR/IVDR post-market surveillance: manufacturer obligations, PMS plans, PSURs, vigilance, incident and trend reporting, field safety corrective actions, EUDAMED and UDI
Post-market surveillance
Post-market surveillance refers to manufacturers’ ongoing oversight of medical devices to confirm they remain safe and effective for patients once authorised and placed on the market. Its aim is to detect whether corrective or preventive safety actions are needed. While the former regulatory framework under the medical device directives did impose compliance duties, it faced criticism for lacking rigour in tracking safety when products are actually used by patients, and for failing to feed that experience adequately into the official safety profile and continuing authorisation. The device scandals involving Poly Implant Prothése (PIP) breast implants in the early 2000s, followed by a widespread hip implant crisis that harmed hundreds of thousands of patients across multiple countries, exposed the shortcomings of a safety certification regime unevenly carried out by different Notified Bodies, and triggered a comprehensive overhaul of medical device regulation. A central element of Europe’s regulatory reform is stronger post-market surveillance requirements. Notably, there is greater focus on gathering clinical and safety data after CE certification and market entry to prevent concealed defects or security risks. Devices must...
Life Sciences
PRACTICE NOTES
EU Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR): scope, classification, GSPRs, conformity assessment, CE marking, technical documentation, expert panels, and designation and oversight of Notified Bodies
This Practice Note outlines the breadth and categorisation of devices governed by Regulation (EU) 2017/745, the Medical Devices Regulation (MDR), and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR) (together, the MD Regulations), along with conformity assessment routes and the designation and oversight of Notified Bodies...
For information on:
key provisions of the MDR and IVDR — see Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
clinical evaluation and investigation of devices — see Practice Note: Clinical evaluation and performance evaluation of medical devices in the EU
post-market surveillance — see Practice Note: Post-market surveillance of medical devices in the EU
European database on medical devices (EUDAMED) and the obligations of economic operators — see Practice Note: The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—EUDAMED and economic operators
Devices that fall within the scope of the MD Regulations—Qualification
Medical devices
General medical devices and active implantable medical devices (AIMDs) are both covered by the MDR. Article 2(1) of the MDR broadens the term ‘medical device’ to include implants, in vitro diagnostic medical devices (IVDs), and devices used for diagnostic prediction or prognosis of a disease, among other concepts...
Life Sciences
PRACTICE NOTES
EU Medical Devices and IVD Regulations: placing devices on the EU market, transitional provisions for legacy devices, EUDAMED roll-out, Notified Bodies, and recent amendments (2023/607, 2024/1860)
This Practice Note summarises Regulation (EU) 2017/745, the Medical Devices Regulation (MDR), and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR), along with the steps for placing a device on the EU market, including how the intricate transitional rules apply to ‘legacy’ devices certified under the former directives system
For fuller analysis of how the MD Regulations affect related topics, see the following Practice Notes:
The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified Bodies
Clinical evaluation and performance evaluation of medical devices in the EU
Post-market surveillance of medical devices in the EU
The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—EUDAMED and economic operators
The EU MDR and IVDR implementing acts and guidance tracker
Medical devices—UK and EU regimes comparison
Legislative framework EU Directives
Up to 25 May 2021, medical devices and active implantable medical devices (AIMDs) within the EU/EEA were governed by the...
Life Sciences
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