“Brexit” is expected to have wide-ranging implications, and one of the areas that could potentially be impacted is the post Brexit medical devices industry. Will the UK keep the EU’s regulatory approval process? Will the UK medical device industry face major changes? Will translation requirements change? The answer to these questions will depend upon the results of a lengthy process negotiating the UK’s formal withdrawal from the EU.
Brexit Medical Devices: Brexit Carries No Immediate Legal Effects
As of today, the UK remains a member of the EU and there will not be any immediate change in either EU or UK law as a result of the vote. EU law does not govern contracts, and the UK is not part of the EU’s monetary union (hence their use of the Pound, rather than the Euro).
However, the vote does begin a lengthy process during which the official terms of the UK’s withdrawal from and future relationship with the EU are negotiated, and will likely have a profound effect.
Brexit Medical Devices: The UK’s Future Relationship With The EU Will Need Negotiation
The ultimate legal impact of the Brexit vote will depend on the terms that are negotiated during the formal withdrawal period. This is presently the main source of uncertainty about the legal implications of the “leave vote”.
In the coming months, both the UK and EU governments will need to formulate their positions for the withdrawal negotiations. Once this is done, the direction of the UK’s future relationship with the EU will become clearer.
How this will impact a post Brexit medical devices market will entirely depend on the economic model the UK chooses to take, and that which the EU accepts. The negotiation period is estimated to take about 2 years, during which time the implications of the medical device industry will become clearer.
What are some of the changes the post Brexit medical devices industry in the UK could see?
- The UK notified bodies responsible for conducting conformity assessment procedures (based on EU directives) may lose their ability to perform such assessments – rendering CE marks granted by them invalid.
- The UK may have to adapt EU regulations and procedures – including those governing medical devices.
- Entirely independent medical device regulations could be implemented, depending on how much the UK distances itself from the EU.
- New trade deals and agreements may have to be forged between the UK and EU member states to allow for the trade of medical devices according to agreed upon conforming standards.
While there won’t be any major changes for some time, manufacturers of UK medical devices (and those looking to sell in the UK) still need to address future plans to mitigate any impact that the post Brexit environment may have on the industry.
To understand just how a post Brexit medical devices industry could look, we must first understand a little about the different economic models that are likely to be considered by the UK.
Brexit Medical Devices: Potential Models Post-Brexit
The UK’s main objective seems to be declaring sovereignty while still having the fullest participation possible in the EU single market. This will obviously require negotiation, and the price of a free trade agreement with the EU will likely include some acceptance of EU regulations.
This trade agreement would depend on the post-Brexit model the UK chooses, of which there are many different possible outcomes. A few of the most likely include the Norwegian/EEA mode, the Swiss/EFTA Model, and the Total Exit/WTO model.
The Norwegian/EEA Model
The UK would need to apply to sign the European Economic Area (EEA) Agreement. It would join Norway, Iceland, and Liechtenstein as EEA member states that are not in the EU.
This agreement would allow the UK to participate in the EU’s single market, but it would require the UK to implement into its national laws the majority of EU legislation designed to encourage free movement of goods, services, capital, and persons. This would include all EU medical device legislation, and the effects for companies under this model would be limited.
However, EEA member states must accept free movement of EU citizens, and this is likely to be a sticking point for the UK in negotiations.
The Swiss/EFTA Model
Another option is for the UK to join Switzerland in the European Free Trade Association (EFTA). This would allow the UK to enter into free trade relations with the EEA and EU by negotiating bilateral agreements on a case-by-case basis. The UK would not be obligated to implement EU laws, although the EU has in the past expressed concerns about the Swiss “cherry-picking” specific EU policies.
Under this model, there would be some pressure to allow for the free movement of workers, but the UK would have greater ability to control its own borders by negotiating the terms of each bilateral agreement individually.
The Total Exit/WTO Model
In this scenario, the UK leaves the EU and ceases to benefit from any part of the single market. The UK would either follow the rules of the World Trade Organization (WTO), or else negotiate a new trade deal with the EU.
What Are The Possible Impacts Of These Models On A Post Brexit Medical Devices Industry?
The impact of Brexit on the UK medical device industry depends largely on the result of the negotiations and the future economic relationship between the EU and the UK. Each of the options would have their own impacts on current medical device regulations and the industry.
One thing that is likely is the UK acting more as an onlooker when it comes to EU decisions regarding legislation and regulation procedures for the medical device industry.
While it isn’t anticipated that a post Brexit medical devices industry will see as many changes as the pharmaceutical industry, what it could anticipate would depend on just how much the UK distances itself from the EU.
The Norwegian/European Economic Area Agreement (EEA) Model
Under this model the UK could still participate in the EU’s internal market, but it would mean integrating EU legislation into existing national laws. This legislation happens to include that for medical devices which covers:
- The Active Implantable Medical Devices Directive
- The Medical Devices Directive
- The In Vitro Diagnostic Medical Devices Directive
The latter two of which would be replaced by regulations regarding medical devices and in vitro medical devices (IVD) once adopted.
The EEA also requires that outside countries looking to sell their medical devices to EEA member states have a designated representative hold the underlying technical documents for CE marks. Seeing as the UK would join the EEA there would be no change to the distribution of products with valid CE marks.
The Swiss/EFTA Model
Adoption of the Swiss/EFTA model would render EU medical device directives and regulations non-applicable, unless an agreement was formed with EEA member states to conform to the aforementioned regulations so devices adhering to EU regulations could be sold in the UK and vice versa.
According to Covington and Burling LLP, if such an agreement was formed, “it would also mean that the EU could continue to recognize conformity assessments conducted by UK notified bodies…the UK manufacturer could continue to act as the legal manufacturer for the purposes of the medical device regulations and would not need to designate an authorized representative within the EEA…[and] a UK company [would not have] to comply with pre-launch notification requirements in the EEA.”
The Total Exit/WTO Model
As the name implies, the total exit/WTO model would mean a complete separation between EU and UK medical device regulations. Devices in the UK would have to comply to laws and regulations that are independently adopted. There is once again room for agreements to be made between UK and EU member states to recognize conformity among standards.
Under this model UK entities looking to sell in the EEA would not be able to hold the CE marks, as a designated representative in the EEA would be required.
While these are a few of the potential changes faced by the post Brexit medical devices industry, there are also implications regarding the continued employment of EU citizens in the medical device and life sciences sector if the UK were to choose a hard exit, as well as those regarding clinical testing of medical devices – something to be covered separately.
How will Brexit Affect Medical Device Translation Requirements?
As far as translation services are concerned, requirements will probably remain the same for the most part. Each EU member state must receive documents accompanying a medical device in their own national official language(s). As a general rule, each country will require the manufacturer to translate documents into at least one of its official languages.
In some cases, Belgium for instance, translation must be provided in all three of the country’s official languages – French, Dutch and Flemish. With a total of 24 EU official languages, and some countries requiring multilingual translations, the process can be somewhat complex.
For international companies marketing their medical devices to the UK following the Brexit, some regulations may change or there may be new regulations in addition to existing EU requirements. But as far as translation requirements are concerned, they will remain the same – all relevant documentation accompanying a medical device must be provided in English and localized for target market audiences in the United Kingdom.
With an anticipated shift in the post Brexit medical devices market, it is wise to look ahead to the future when forming strategies for market entrance and market share stability in the UK. As always companies should use a translation agency to translate all documents associated with a medical device, ensuring accuracy and professionalism – one thing that won’t be changing in light of Brexit.
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Sources:
- https://www.davispolk.com/files/2016-06-24_Legal_Implications_Brexit.pdf
- https://corpgov.law.harvard.edu/2016/06/24/brexit-legal-implications/
- https://www.theguardian.com/commentisfree/2016/jun/21/legal-implications-britain-votes-leave-eu-brexit
- http://medical.electronicspecifier.com/around-the-industry/the-impact-of-brexit-on-the-medical-device-industry
- https://www.emergogroup.com/print/blog/2017/01/hard-brexit-and-its-effects-medical-device-companies?action
- https://www.cov.com/-/media/files/corporate/publications/2016/07/impact_of_brexit_on_eu_medical_devices_regulation_and_structures.pdf
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