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Shuna Mason

Partner

CMS Cameron McKenna Nabarro Olswang LLP
Cannon Place
78 Cannon Street
London
EC4N 6AF
United Kingdom
Languages English, German

Shuna Mason is a partner in the Lifesciences group at CMS UK and is the firm’s lead on regulatory and product liability issues.

She specialises in the lifesciences and consumer products sectors, covering pharmaceuticals, medical devices, in vitro diagnostic devices, human tissue, cosmetic and plant protection products.  

Shuna advises companies on regulatory, compliance and liability issues in relation to product lifecycles as well as business models, on both international as well as national issues. She frequently manages and co-ordinates international regulatory, compliance and liability / litigation advice. She is also actively involved in UK and European trade associations in the medical devices and diagnostics sectors, including as an invited member of the MedTech Europe legal affairs focus group and its ethical business code committee and brings a broad perspective on healthcare sector issues when advising clients.

Shuna’s team advises in relation to pre-market development, market authorisation or conformity assessment as well as in relation to (pharmaco-)vigilance and other post-market compliance issue, including postmarket surveillance, field safety corrective action, labelling/IFU and all types of promotional materials and activities, including compliance.

Shuna has extensive experience in handling English product liability disputes and other litigation, including regulatory enforcement and judicial review administrative challenges.  She is also familiar with co-ordinating and managing product liability litigation and recalls across Europe and beyond for manufacturers and insurers.

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Chambers ranks Shuna for regulatory and as a Band 1 individual for product liability.

Shuna Mason leads the firm's regulatory practice and is well known in the medical devices, pharmaceuticals and consumer health products markets. She is also recommended for product liability defence instructions.

Chambers

Shuna is listed in the 2016 edition of Who's Who Legal: Life Sciences – Regulatory.

Relevant experience

  • Evolving lifesciences business models to include eHealth products or connectivity, including advice on borderlines between manufacturer and healthcare provider regimes and triggers for healthcare provider registration requirements (Care Quality Commission or equivalent) and remote healthcare and cross-border healthcare regulatory and liability issues.
  • The legal status of clinical use software and potential medical device / IVD (or accessory) status for a wide variety of different software products, including surveys of legal status across multiple regions.
  • A US-based orphan medicinal product manufacturer on the commercialisation, reimbursement and compliance processes across G5 group countries.
  • A UK R&D company on the implications of the EFPIA Disclosure Code.
  • Takeda Pharmaceutical Company Limited on the integration of its business with that of acquired Swiss drug company, Nycomed A/S.
  • Product borderline issues (drug / device / cosmetic / human tissue / biocide / “unclassified” borderlines) and appropriate product development and marketing strategies, including surveys of viability of different product claims across multiple jurisdictions.
  • A Japanese global pharmaceutical company on the clinical trial insurance requirements across 18 jurisdictions and also for a clinical trials insurer on multi-jurisdictional insurance requirements, policies and certificates.
  • A Japanese pharmaceutical company on the EU labelling implications for generic companies of EU usage patents.
  • Merger partners in the context of a competition inquiry about API and excipient GMP manufacturing requirements.
  • Various pharmaceutical and medical device companies on compliance with the UK Bribery Act and with the ABPI Code of Practice / MedTech Europe Code of Ethical Business Practice and in relation to investigation of violations and complaints, including coordinating compliance systems reviews across multiple jurisdictions.
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Publications

  • Contributed 2 chapters to publication “The Textbook of Pharmaceutical Medicine” (7th edition) published by WILEY-BLACKWELL: “Legal and ethical issues relating to medicinal products” (co-author) and “European regulation of medical devices” (sole author) 
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Lectures list

  • Informa’s Pharmaceutical and Medical Device Labelling Summit in Berlin, October 2015: Claims in promotional materials: legal implications of non-compliance
  • ABHI’s Regulatory Conference in London, September 2015 (Chair): Importers and Distributors: New Roles and Responsibilities under the Medical Devices Regulations
  • Informa’s 23rd EU Pharmaceutical Law Forum in Brussels, May 2014: Review of the EU clinical trials regulation
  • ABHI’s seminar, UDI Systems: The Here and Now of Implementation in London, May 2014: UDI for medical devices in the EU: legal obligations and implications for manufacturers and the supply chain
  • DIA, 26th Annual EuroMeeting in Vienna, March 2014: Development of the EU Regulatory Framework for Companion Diagnostics
  • ABHI’s MedTech Conference in London, October 2013: Chair of Regulatory Session
  • DIA, Combination Products Workshop in Basel, October 2013: Current and Future Regulatory Requirements for CDx
  • DIA, 25th Annual EuroMeeting in Amsterdam, March 2013: Development of the EU Regulatory Framework for Companion Diagnostics
  • ABHI’s Regulatory Conference, the MDD Revision: a definitive overview, in London, October 2012: Revision of the Medical Devices Directives: the Commission’s proposals of 26.9.12
  • MHRA Design Management Workshop in London, 2010: Device Design Management: the current legal parameters
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28 April 2020
Key con­sid­er­a­tions for con­duct­ing in­tern­al in­vest­ig­a­tions re­motely
With so many busi­nesses in lock-down, many in­tern­al in­vest­ig­a­tions will have to be con­duc­ted re­motely, with in­vest­ig­a­tion teams, em­ploy­ees, ex­tern­al coun­sel and oth­er pro­viders work­ing from home for the...
20 April 2020
CMS Ex­pert Guide to ad­vert­ising of medi­cines and med­ic­al devices
Ad­vert­ising of phar­ma­ceut­ic­als and med­ic­al devices is a chal­len­ging area for the Life Sci­ences and Health­care in­dustry.The leg­al frame­work is con­stantly chan­ging. Due to very few laws on this area, there...
18 June 2020
MHRA re­leases up­dated guid­ance on med­ic­al device soft­ware and apps
On 4 June 2020, the Medi­cines and Health­care products Reg­u­lat­ory Agency (“MHRA”) pub­lished its up­dated guid­ance on med­ic­al device stand-alone soft­ware, which is in­ten­ded to cla­ri­fy the types of soft­ware...
06 March 2019
Life Sci­ences Reg­u­lat­ory
Leg­al and reg­u­lat­ory frame­works are con­stantly evolving in the life sci­ences sec­tor to keep up with in­nov­at­ive ther­apies, dia­gnostics and oth­er med­ic­al tech­no­lo­gies, as well as in­creas­ing ser­vices pro­vi­sion...
20 April 2020
CMS Ex­pert Guide to can­nabis law and le­gis­la­tion
In re­cent years can­nabis trade and re­lated activ­ity has de­veloped in­to a growth busi­ness area. In the life sci­ences and health­care fields there have been in­creases in the num­bers of pa­tients hav­ing ac­cess...
26 March 2020
European Com­mis­sion pro­poses delay­ing the May 2020 ap­plic­a­tion of the EU...
The European Com­mis­sion has con­firmed it is work­ing on a pro­pos­al to delay for one year the date of ap­plic­a­tion of the new EU Med­ic­al Devices Reg­u­la­tion 2017/745/EU (the “MDR”) in light of the Cov­id-19...
11 January 2017
Con­sumer products and re­tail dis­putes and in­vest­ig­a­tions
The Con­sumer Products in­dustry is chan­ging fast. You need a leg­al ad­visor that un­der­stands your world.Our spe­cial­ist con­sumer products group can help you nav­ig­ate the leg­al and com­mer­cial chal­lenges of...
06 March 2020
MDR - Agree­ments with third party con­tract man­u­fac­tur­ers
The EU Med­ic­al Device Reg­u­la­tion, which comes in­to force on 26 May 2020, will lead not only to big changes in how med­ic­al devices are reg­u­lated, but also to more thought be­ing giv­en to agree­ments between...
08/07/2016
Our ehealth cap­ab­il­it­ies
With tech­no­logy and di­git­al in­nov­a­tion at the fore­front of many ad­vance­ments in the lifes­ci­ences in­dustry and in health­care de­liv­ery, we un­der­stand that you will be look­ing to con­sist­ently push bound­ar­ies...
07 February 2020
MHRA up­dates guid­ance on with­draw­al of no­ti­fied body ser­vices (UK)
The Medi­cines and Health­care products Reg­u­lat­ory Agency (MHRA) has re­cently is­sued guid­ance for situ­ations where a no­ti­fied body with­draws all, or part, of its ser­vices in re­la­tion to med­ic­al devices...
06/02/2016
CMS launches Glob­al Product Li­ab­il­ity team in Lifes­ci­ences
Our newly formed spe­cial­ist Product Li­ab­il­ity Team con­sists of over 40 law­yers across Europe, Rus­sia and China, with in-depth know­ledge of the Lifes­ci­ences in­dustry (in­clud­ing their in­surers).They have...
13 December 2018
Di­git­al Health - The new reg­u­la­tion of med­ic­al soft­ware and apps
The new Med­ic­al Devices Reg­u­la­tion 2017/745 (“MDR”), which comes in­to force in May 2020, rep­res­ents a huge over­haul of the reg­u­lat­ory frame­work gov­ern­ing med­ic­al devices in the EU.  The com­pli­ance...