The changes that could emerge from the British decision are likely to impact a number of other industries in a huge manner. Medical devices are one of the industries that will see major changes in the years to come. There are a number of reasons for which the medical devices industry will undergo major changes.

1. NetZealous LLC

2. In the last week of June 2016, the world and Europe in particular watched
tensely for the result of the British referendum on its people’s decision on
whether to stay with Europe or leave it. By a hair’s breadth, the
referendum decided that the EU should leave Europe. This had serious
implications for the political establishment, with some careers being ended
by this vote and some others’ stars rising. No matter what the political
repercussions of this decision; the major area in which the repercussions
were felt related to the economy.
Certainly, this decision is not going to be without major effects for the
British, European and the global economy in varying degrees.
Assessments are being voiced about the possible fallouts of this decision
on a number of areas relating to the life sciences and healthcare. For
example, the field of clinical research will now be left with the possibility of
having to either fully or partially forsake the benefits of collaborative
research and utilization of collective talent that were a hallmark of a
Britain-included, unified EU.

3. The changes that could emerge from the British decision are
likely to impact a number of other industries in a huge manner.
Medical devices are one of the industries that will see major
changes in the years to come. There are a number of reasons
for which the medical devices industry will undergo major
changes. These are some of the reasons:

4. • The size of the medical devices market in the EU is put at
over $120 billion. The over 22,000 medical devices
manufacturing companies in the EU provide employment to
over 500,000 people
•
• The EU puts back around one-twelfth of its earnings in this
sector into research, because of which its technological
innovations bring medical devices faster to the market than
in Japan or the US
•
• Medical devices is an area in which Britain has been a very
proactive participant when it came to framing regulatory
rules, as well as being a major hub for medical devices in
Europe.

5. Of course, Britain is not going to sever links with Europe in a
day or two. A few processes and protocols need to be fulfilled
before the actual splitting takes place. Firstly, the whole of the
UK has to invoke the provisions of the Lisbon treaty, mainly
Article 50. This sets out the process by which the separation
is going to take place, opening up the issue of negotiations
on the way the exit is going to take place and other related
issues. This is going to be phased over at least five to ten
years. Given this fact, we are not likely to see drastic changes
happening on the horizon anytime soon. Even then, both
during and after this phase, there are going to be
implications.

6. Before getting to understanding the implications of the Brexit
policy on the medical devices market for Britain and the rest of
the continent, it needs to be mentioned that as of now, since
Britain is part of the EU and continues to be till it takes legal
and legislative action for exiting from this group; it is bound by
the pan-European instrument, the EU Medical Directives. Till
the time Britain actually says goodbye to the EU; it is bound by
the regulations and policies framed by these directives.
Among the upcoming legislations whose implementations
could take place during this interregnum are the EU Medical
Devices Regulation (MDR) and In Vitro Diagnostic Devices
Regulation (IVDR). The scope of these legislations includes:

7. • Stating and putting in place the conditions for ensuring the
pre-market conformity of certain medical devices with the
stated requirements
•
• Supervising post-market and monitoring traceability of
devices throughout the supply chain.
These regulations are due for EU approval by September
2016, and their implementation is to begin in 2020. So,
unless Britain opts out of the EU and makes its own laws on
these subjects by 2020, which is a highly unlikely possibility;
Britain is bound to implement these two provisions as a
member of the EU. What provisions and regulations it will
legislate in the future is unknown at this point of time.

8. Following the separation, there is a very big possibility of
Britain framing its own regulations in relation to medical
devices, leading to a system in which there will be more than
one set of regulatory requirements to deal with for companies
that want to market medical devices in both the EU and the
UK.
The areas on which a Brexit decision is likely to cast the most
uncertainly relates to two areas: CE Marking and the status of
Authorized Representatives

9. CE Marking is a stamp which certifies that a medical device has met the
required quality standards set out by the Directives of the European
Commission and issued by what this commission deems a Notified Body,
which could be in any Member State of the EU. What will happen to the
status of a Notified Body once the UK leaves the EU is not very clear or
predictable at this stage.
So, this is likely to be a contentious and uncertain area as of now, with the
British Standards Institution not having announced any plans to put in
place a mechanism that replaces the present arrangement in relation to
Notified Bodies. Whether the Notified Bodies throughout the EU will be
considered good enough for the UK and vice versa is a major question
that will challenge lawmakers and marketers alike, and is something on
which a clear picture is going to take quite some time and protracted
haggling to emerge.

10. The status of Authorized Representatives, or what are called EC
Representatives, in a future, non-British EU is a grey area for now.
Authorized Representatives are appointed by the EU to decide on giving
access to the EU market for medical devices manufacturers who are from
outside the EU. So, once Britain leaves the EU, what is going to happen to
the EC Representatives based in the UK hangs in the balance.
Since they are not likely to be able to act as representatives for any
manufacturer, there is now going to be a fresh round of uncertainty about
the status of these EU representatives, who currently number over 70. A
system in which there is a fresh round of regulatory requirements to be
satisfied and with it, having to get regulatory or other approvals from an
added, separate body is a possibility many medical device manufacturers
will have to grapple with.

11. In the light of these uncertain scenarios; analysis is being
made that there could be at least these different
possibilities:
One, the UK could become a part of the economic
groupings of the EU, such as the European Economic Area
(EEA), or the European Free Trade Association (EFTA), or
work out a similar arrangement by which the CE-marked
medical devices will be allowed to flow and trade freely
between the EU and the UK, and the Notified Bodies and
Authorized Representatives will continue to work in their
present positions, albeit with some conditions.

12. Second, the EU and the UK would work out an arrangement by which CE-
marked medical devices made from elsewhere in the EU could be sold in
the UK, and continue to have the British Authorized Representative in EU
countries. With some conditions, Notified Bodies and Authorized
Representatives could continue to work from inside the UK.
Third, work out an agreement for trading medical devices between the EU
and UK, something similar to agreements between different nations, where
the UK and EU could sell each other’s medical devices in each other’s
markets, with some conditions.
Fourth, the UK can trade medical devices with the EU under an agreement
framed by the World Trade Organization (WTO). This is considered
unattractive for the main reason that the world body does not need to be
invoked for what essentially are trade differences between two groups that
are closely related to each other in many ways.

13. It is natural for anyone to get bogged down by the difficulty in understanding
and implementing the provisions of these legislations and different
possibilities. Professional trainings help professionals and organizations in
the medical devices industry to make sense of the legislations, regulations
and technologies that pervade the medical devices market and to get a
grasp of the various implications of the Brexit decision.

14. A professional trainings provider like NetZealous LLC,
headquartered in Fremont, CA is the ideal partner for these
professionals and organizations to move towards the goal of
gaining clarity on the issue concerning medical devices
following the Brexit decision. With a huge number of experts in
the field of medical device regulation; NetZealous LLC helps
players in the medical devices industry clear the air regarding
all the aspects of post-Brexit medical devices.