Medilink NOE News Summer 2020 Summer 2020 - Page 6
CE-IVD MARKING FOR ITS
SARS-COV-2 TEST AND
LEAVING THE EU -
IMPLICATIONS FOR THE LIFE
SCIENCES AND MEDICAL
If no trade agreement is reached by 31 December 2020, there
could be disruptive consequences for the life sciences industry.
Businesses should prepare for the eventuality of the UK trading
with the EU on World Trade Organisation terms.
Bad News: Disruption
• Prepare for potential difficulties trading or obtaining new
contracts whatever the deal with the EU
• Expect a decline in stability for contracts binding for EU and UK
businesses, due to the unknown impact on many economic factors
• Without a satisfactory trade deal, protections guaranteed by the
GDPR regarding international transfers of data are uncertain
Good News: Regulatory Revisions
• The UK has already transposed EU legislation into national law,
creating a temporary patchwork of applicable legislation and
preventing significant disruption.
• The UK has already communicated its intention to align, where
possible, to the EU Clinical Trials Regulation 536/2014 (CTR).
• The UK MDR 2002 has been amended to reflect the upcoming EU
Medical Devices Regulation and the EU In Vitro Diagnostic Medical
Our advice to business
• Audit current contracts with EU businesses for likely changes.
Preventive measures should be included in contracts, either
through amendments or by adding Brexit-related termination
• For new contracts, consider opting for short-term agreements
and consider issues like delivery, payment, etc.
• Examine the implications of trading with EU-based companies
and the ability to meet contractual obligations, for example, supply
chain issues due to customs disruption. Brexit will not relieve
businesses from their contractual obligations
The UK will have to recreate its own legal order to some extent.
We can expect the emergence of an ‘a la carte’ regulatory
regime, which will increase the uncertainty of contract law and
business relationships. However, businesses can count on the
UK government’s intention to adjust rapidly to beneficial EU
We are a corporate partner of Medilink UK and the exclusively
recommended provider of legal services to Medilink’s North of
England members. View James Lawford Davies’ webinar on the
legal implications of Brexit for the life sciences and healthtech
AI AND IP -
A NEW FRONTIER
AI (Artificial Intelligence) has become the
new buzzword in the sector. Even now, AI -
machines that can become better at a task
typically performed by humans with limited
or no human intervention – is moving to ML
(Machine Learning) - an AI process that uses
algorithms and statistical models to allow
computers to make decisions, without having
to explicitly program it to perform the task.
The FDA has already approved a diagnostic
device powered by a deep learning algorithm
trained on extensive set of images annotated
by experts. We also have ML tools carrying
out some of the science and conceiving
inventions. So, what does this all mean for the
Who is the inventor of any AI/ML conceived
invention? The EPO recently explained that it
had refused two patent applications naming
the machine DABUS as an inventor because an
inventor must be a natural person and various
national courts have issued decisions to this
effect. The applicant, DABUS’s owner could
also not have had ownership transferred to
him because DABUS has no legal personality
and so cannot hold property. Will this be
When is an AI/ML invention obvious because
the use of AI/ML is obvious in itself? We are
probably already there in some instances.
An invention also has to be sufficiently
disclosed. However, sometimes we don’t fully
understand ML inventions – we can see the
effect but not always how it works.
AI/ML clearly needs big data. Yet none of the
six regions of Health Data Research UK is
located in the North. So, the North will rely on
its Digital Health workforce. We have almost
30% of the country’s total Digital Health
workforce - a force to be reckoned with.
Please note - the views being expressed
are those of the author and not necessarily
LR DAME SARAH STOREY, PROF ROB COPELAND, DAN JARVIS MP
SHEFFIELD HALLAM LAUNCHES
RESEARCH CENTRE FOR
Sheffield Hallam University has opened the most advanced
research centre in the world for developing innovations that
will increase physical activity and improve population’s health.
The new multi-million Advanced Wellbeing Research Centre
(AWRC), supported by £14million funding from the Department
of Health and Social Care and £905k investment from the
European Regional Development Fund, has been officially
opened by the Active Travel Commissioner for Sheffield City
Region and Britain’s most successful female Paralympian,
Dame Sarah Storey.
As the centrepiece of the Sheffield Olympic Legacy Park, the
AWRC is dedicated to improving the health and wellbeing of
the population through innovations that help people move. Its
mission is to prevent and treat chronic disease through codesigned
research into physical activity, while attracting new
jobs and investment to the region.
The Centre is supported by several partners including: Canon
Medical Systems, Westfield Health, EXOS, the National Centre
for Sport and Exercise Medicine in Sheffield, Sheffield Children’s
Hospital Charity, Ingesport and parkrun.
Dame Sarah Storey said: “It is fantastic that innovation into
helping people live more healthy and active lives is taking
place here in the Sheffield City Region. Physical activity can
improve both physical and mental health for people of all ages
and abilities, and it’s important that everybody is given the
opportunity to be active.
“Our vision includes creating a 2040 Active Travel network which
is safe and suitable for all, to allow everybody to start building
physical activity into their everyday lives.”
Mayor Dan Jarvis, Mayor of the Sheffield City Region, said: “I
am delighted that the Advanced Wellbeing Research Centre
will bring jobs and investment to the region, whilst driving new
research into the health of populations across the world, as well
as our own communities.
“South Yorkshire is now home to the world’s most advanced
research centre in the world for wellbeing research, the
Advanced Manufacturing Research Centre, and National Centre
for Excellence in Food Engineering.”
The AWRC features indoor and outdoor facilities for multidisciplinary
researchers to carry out world-leading research
on health and physical activity in collaboration with the private
sector, charities and the community.
QuantuMDx Group Limited, a UK-based life
sciences company developing transformational
point-of-care molecular diagnostics and
Medilink member, has received CE-IVD marking
for its SARS-CoV-2 test under the In Vitro
Diagnostics Detective (98/79/EC), which will
enable the use of the device within the EU.
The company has registered the test with the UK’s
Medicines & Healthcare Products Regulatory
Agency (MHRA). The company has also applied to
the US Food and Drug Administration (FDA) for
Emergency Use Authorisation.
The assay has been designed with the most upto-date
sequence information to ensure 100%
coverage of all known SARS-CoV-2 sequences.
Working with a British manufacturing partner,
Biofortuna Limited, the company has increased
the production capability up to 2 million tests a
week with the potential to scale up to 3 million
tests per week.
Jonathan O’Halloran, Chief Executive of
QuantuMDx, said: “Gaining CE-IVD marking now
enables us to sell our SARS-CoV-2 detection
assay directly into the European Union, as well
as other territories worldwide that adhere to
its regulations. This is another exciting step
forward for QuantuMDx as we commercialise,
join the international testing effort and support
governments in their test, track and trace
QuantuMDx has also announced the
appointments of Jonathan O’Halloran as Chief
Executive Officer and Neil Butler as Chairman of
the Board. Jonathan O’Halloran is the company’s
Co-founder, former Chief Scientific Officer and
inventor of many of its proprietary technologies.
Neil Butler was appointed to the Board as
Non-Executive Director last summer and is a
seasoned IVD specialist.
The board changes coincide with QuantuMDx’s
transition towards commercialisation and the
launch of its Q-POC™ high risk HPV genotyping
assay in early 2021
LEGAL INTERNATIONAL PAYMENTS INSURANCE IP