Medical Devices and Brexit

The dust has barely settled on the Brexit referendum and the future planning yet to begin. However, the continued uncertainty on structures and funding is allegedly threatening the availability of research grants in the UK and impacting on the ability of Medical Device manufacturers to produce long term plans.

Given the potential implications it is important to consider what the landscape may look like.

There are a number of models that are being considered, the main ones are as follows:

The Norway Model

The UK exits the EU but joins the EEA which means that it would retain access to the single market. This would require the UK implementing key EU legislation including the free movement of people within the EU. The UK would need to implement all new EU legislation including the new Medical Devices Directive once it has been adopted. Significant benefits of this model include that CE marks would remain valid across the EEA and the ability to market medical devices across the EEA would be retained.

The Swiss Model

The UK exits the EU but joins the European Free Trade Association. This would enable the UK enter free trade relations with the EEA. This option would not require the UK to adopt EU laws (including the Medical Devices Directive) although this may be a requirement of any treaties with the EU under which the EU and UK mutually agree to allow the marketing of CE marked medical devices.

The Canada Model

The UK could seek to trade with Europe under a special agreement comparable with the current arrangements that Europe has just agreed with Canada. The UK would need to put in place its own legislation and guidance which could be, but is not required to be, based on EU Directives.

Medical Devices in the UK will still be required to be CE marked in order to be marketed in the EU and it is likely that in the UK the CE mark (or an equivalent) will still be required. Depending on the option above, UK manufacturers may need to appoint an EU based authorised representative to market into the EU. Additionally, manufacturers based outside of Europe may need to consider whether having a European Authorised Representative situated in the UK will remain lawful or whether they will need to make arrangements to move or recruit an additional representative in the EU.

In June of this year the European Council endorsed the draft Medical Devices Regulations with the aim of the draft regulations being in place in Europe by the end of the year. Given the UK will remain within the EU for the time being it will be subject to any such new legislation until the final exit.

Whilst the future has not been painted as rosy there could be benefits to Brexit for the Medical Devices market. Freedom from state aid could provide the UK with a mechanism of investing in science and technology which could provide the UK with a unique position in Europe to create a centre of excellence. Further, given the slow speed of putting in place any new legislation across the EU as a whole, separation may allow the UK to act quicker to bring in legislation where it wished to do so.