Medilink North of England News 2019 Medilink NOE News 2019 | Page 3
THE PERFECT STORM – NEW MEDICAL DEVICE
REGULATIONS, NOTIFIED BODY CAPACITY, AND BREXIT.
The theme of our last newsletter was the
new Medical Device and IVD Regulations
which came into force on 25 May 2017. The
transition period is therefore now well
under way, with medical device companies
having to comply with the new regulations
no later than 26 May 2020 (less than a year
away!) and 2022 for IVD companies. What
has largely gone under the radar is that
the time it takes to get a CE Mark audit has
increased dramatically due to capacity
issues and the reduced number of notified
bodies. Of course, to make the ‘perfect
storm’ we have BREXIT and whether we
end up with a ‘DEAL’ or ‘NO DEAL’ Brexit,
each with different regulatory scenarios.
As you will be aware, the UK has agreed
with the EU an extension to Article 50 until
31 October 2019 and the new government
leadership is committed to come out of the
EU by this date.
What does this mean in practice? In the
event of a No Deal exit, for a limited period
only, companies will continue to be allowed
to place products on the UK market that
are in conformity with the applicable
EU Directive and that carry a CE mark
– certificates issued before exit day will
continue to be recognised and there won’t
be any changes of labelling required. A new
UK regulatory system will be introduced,
given that the UK’s participation in the
European regulatory network will end,
which will almost certainly mirror all the
key elements of the EU regulations. In the
event of a ‘Deal Brexit’, with an agreed
withdrawal agreement, there would be
a time limited implementation period
providing a bridge to a future relationship
between the UK and the EU, and companies
would trade on the same terms as now
until the end of 2020. And of course, there
is a third scenario that may be becoming
increasingly remote, that we do not leave
the EU at all.
What is clear, is that whatever the position
going forward, you will need to undertake
risk analysis on an ongoing basis to identify
risks, impact and mitigation. If you have
not already undertaken a gap analysis
to understand the difference between
the current MDD and new MDR e.g., the
additional clinical evidence required, costs,
time lines, etc., then this is something that
you should prioritise. Similarly, there is
a real need to make initial preparations
for a Deal / No Deal Brexit. The business
representatives on the three Medilink
Regional Advisory Groups (North West,
North East & Yorkshire & Humber) have
made it clear that regulation is now the
number one issue facing members. As
such Medilink has recently stepped up its
support in this area through:
i) education / skills development: – initial
conference on global regulations held on
9th July (see page 10)
ii) raising the issue of the lack of capacity in
Notified Bodies at a national level
iii) working with Innovate UK in undertaking
a survey of SME readiness for the new
regulations
iv) providing a voice from SME’s on what
the government should be looking for in
a future economic partnership around
regulation, post BREXIT.
Kevin Kiely
Chief Executive Medilink North of
England Limited
MEDILINK NOE WELCOMES NEW CORPORATE PARTNER - HILL DICKINSON
Medilink North of
England is delighted to
have teamed up with
commercial law firm, Hill
Dickinson, as our latest
corporate partner. The
three-year agreement
with the law firm and its
180-strong specialist
health division, provides
a number of important
benefits to Medilink
members and the wider sector. The announcement comes as
Hill Dickinson sets out its credentials as a leading provider of
services to the life sciences and health tech sectors.
Hill Dickinson is a leading commercial law firm that acts for
more than 100 independent healthcare, pharmaceutical, life
sciences, health-tech and biotech companies as well as over
100 NHS bodies. Key sector knowledge, combined with a strong
corporate offering, allows them to provide an unparalleled breadth
of experience and expertise across the life sciences and health
tech sectors, providing clients with first class and cost-effective
support on a wide range of legal transactions and matters.
The Hill Dickinson team includes health tech lawyers, who offer
advice in relation to medical devices and pharmaceuticals, and
life sciences lawyers whose various specialisms include cell and
gene therapy, reproductive and genetic technologies, embryo
research, ethics and clinical trials.
These experts are complemented by a team of corporate lawyers
whose experience in regulatory matters and corporate finance
enable them to provide a comprehensive range of sector-specific
legal services.
James Lawford Davies, a partner at Hill Dickinson, whose own
specialisms include reproductive and genetic technologies,
embryo research, and cell and gene therapies, said: ‘Our
partnership with Medilink North of England is an exciting new step
for us and we’re delighted to be working together with Kevin Kiely
and the Medilink team.
“As Medilink North of England’s recommended provider of legal
services, we’re also very much looking forward to getting to know
other members and supporting them in any matters related to our
specialisms in health tech and life sciences.”
Hill Dickinson lawyers have a real understanding, not only of the
legal and commercial issues Medilink members face but also
of the strategic arena and regulatory environment, policies and
principles that underlie and influence the health care sector in
which your business operates.
To contact Hill Dickinson and find out more
about how they can help your business,
visit their website at hilldickinson.com
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