The Prime Minister, David Cameron, has referred to the 23 June referendum on Britain’s membership of the European Union as a ‘once in a generation’ decision – more significant than a general election and one that ‘lasts for life’.
Both sides of the debate have campaigned extensively, but the ramifications for the medical device industry in particular have largely escaped mainstream coverage, with the exception of a BBC News piece interviewing the owner of a medicinal leech company.
High on the list of unanswered questions would be the status of CE marking and the route to market for UK companies selling into the EU in the event of Brexit. UK manufacturers would no longer be able to claim automatic entitlement to market devices in the EU on the basis of a completed conformity assessment and display of a CE mark, and UK based Notified Bodies (NBs) finding themselves outside of the EU would no longer be able to operate.
Any companies, whether based in the UK or not, currently registered with UK NBs would need to transfer to an EU alternative and seek an authorised representative in a Member State, with conformity assessments undertaken in the same way as any other non-EU country. Less clear would be how devices manufactured and certified elsewhere in Europe would be treated in the UK – this would depend on how closely any future UK regulatory framework mirrored the EU system. Potential problems could be avoided by following the Swiss model of a bilateral agreement, establishing mutual recognition of medical devices with the EU.
Precedents for systems of mutual recognition exist outside of Europe, with examples in Australia, New Zealand and Canada covering medical devices, but such a system would still inevitably require the UK to comply with EU legislation, without its involvement in shaping it.
Future of regulation
Any primary UK legislation that has already been put in place to implement EU laws would continue to be in effect until and unless it was amended by Parliament. A thorough audit of legislation would need to take place during this transition, and it is impossible to say what the outcome would look like.
From outside the EU, we would no longer be involved in the process of drawing up and amending the regulations that govern the manufacture, sale and distribution of medical devices in the EU. The process of creating the new Medical Device Regulations (MDR) has seen extensive involvement of the Medicines and Healthcare Products Regulatory Agency – an organisation with significant standing within Europe, but one that would lose its voice in the event of Brexit.
Britain could maintain membership of the European Economic Area, along with Norway, Iceland and Liechtenstein, affording some continued involvement in the development of legislation, albeit less than if we remained, in exchange for financial contributions and an agreement to implement the full body of legislation itself. It’s unclear, however, what the extent of this involvement would be.
Going it alone
A more potentially disruptive option would be for the UK to establish its own regulatory system for medical devices without attempting to mirror that of the EU. For companies selling and manufacturing in the UK alone, this could appeal for its potential to afford greater freedom and a more permissive regulatory environment. However, such benefits would be outweighed for UK companies wanting to become involved in the EU, where the disparity in regulatory requirements would undoubtedly hinder their ability to bring products to market.
The detrimental impact on business of leaving the EU is an issue that has been raised by a number of BDIA members. Belinda Mayoh, Marketing Director at Kemdent, describes Brexit as a serious concern. With EU regulations being used on a daily basis with customers, she comments that ‘we feel leaving the EU would cause a lot of confusion, cost us time and affect our sales and profitability’.
Mark Sanderson, Business Development Manager at Advanced Healthcare Ltd, comments, ‘Being part of the EU, whilst not a perfect organisation, does allow us to trade “hassle free” with such a large potential market’, adding that ‘our direct European based competitors will have a trading advantage that will make us less competitive in Europe’.
Unfortunately it is simply not possible to make any accurate predictions of what the industry would look like post-Brexit; the best that can be done is to identify the areas of change. This in itself is a difficult task given the amount of legislation involved and the uncertainty surrounding what decisions might be taken in the period of transition that would follow a potential Brexit.
Author Adam Stanley
Policy Support Co-ordinator at the BDIA
Posted by Gemma