NetZealous LLC

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.

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:

• 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

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• 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

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• 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.

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.

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:

• Stating and putting in place the conditions for ensuring the pre-market conformity of certain medical devices with the stated requirements

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• 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.

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

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.

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.

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.

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.

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.

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.