Brexit: What are the biggest challenges for businesses now that the UK has left the EU?
Three and a half years after UK citizens voted in favour of leaving the EU, the UK is formally no longer part of the European Union since January 31st, 2020, a date which also marked the beginning of a transition period scheduled to finish on December 31st, 2020. During such transition, the UK will negotiate a trade deal with the EU while still temporarily being part of the EU customs union and single market but will be outside of EU Parliament and political institutions. While the negotiations are taking place, businesses in the industrial sectors are still trying to understand what will happen after the transition. Following new regulations and consulting in linguistic matters is now more important than ever.
United Kingdom leaves the EU: What will happen now and what are the biggest challenges for businesses that export or have HQs and offices in the UK? With this short reminder we want to address the consequences of Brexit for companies dealing with industrial products, medicines, medical devices and clinical trials, and intellectual property in the event a trade deal between the UK and the EU is not reached after the transition period.
Brexit consequences: the EU guidelines on industrial products
The European Union has tried to provide answers about some consequences of Brexit by issuing a series of guidelines that have also been summarised in a publication on the consequences of Brexit by Qarad, a Belgian company specialising in Regulatory Affairs and Quality Systems for the IVD and Medical Device industry, in an attempt to shed some light on the issue in view of the forthcoming deadline.
Here are the main points highlighted by both documents:
Goods placed on the EU market before the withdrawal date, which are, goods distributed in the EU, manufactured in the EU, imported into the EU and delivered before the withdrawal date, will continue to be available without undergoing any modifications, as they were placed on the market;
Regulatory compliance: those based in the UK, with responsibility for regulatory compliance, will cease to have any authority on the date of the UK’s withdrawal. Regardless of when products were placed on the market, manufacturers will have to appoint a new representative based in the EU. Goods to be placed on the market after the withdrawal date will have to be re-labelled in compliance with EU legislation; goods placed on the market in the EU-27 before the withdrawal will be considered correctly labelled;
Importers (of products imported via the UK and placed on the EU market before or on the withdrawal date): according to guidelines published by the EU, UK-based importers and manufacturers will no longer be EU operators as of the withdrawal date. So those receiving goods from UK manufacturers or UK-based importers will become importers, and will no longer be distributors, if they make a product available in the EU for the first time;
Transfer of Notified Bodies certificates: CE certificates issued by a UK Notified Body (NoBo) will no longer be valid, and a CE certificate issued by an EU-27 Notified Body will be required. Economic operators must either apply for a new certificate with an EU-27 NoBo or arrange for a transfer of the file and the corresponding certificate to an EU-27 NoBo before the withdrawal date. After withdrawal, the EU declaration of conformity and the NoBo certificate will have to be updated.
Accreditation services (that is, the attestation, issued by a national accreditation body, that a conformity assessment body meets the requirements to carry out a specific conformity assessment activity): accreditations by the UK Accreditation Service will no longer be valid or recognised in the EU-27 as of the withdrawal date.
Consequences of Brexit regarding medicines, medical devices and clinical trials
For key items under the EU Medical Device Regulation (MDR) and IVD Regulation (IVDR), the UK government has worked on a series of amendments enabling UK rules to be fully operational in the event of a no-deal Brexit known as The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019. Compliance with these rules will be mandatory for anyone wishing to put medical devices on the UK market. The amendment has been cited in the Qarad report “No-deal Brexit impact”.
The main points highlighted by the Department of Health and Social Care are:
- Medicines: after withdrawal, and without a deal, the UK will no longer be part of the EU regulatory network and the MHRA will assume functions previously performed by the EU in the UK market until the UK law is changed. Medical devices: the UK will recognise medical devices approved for the EU market and bearing the CE mark. The UK will comply with all key elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulations (IVDR), which will apply in the EU from May 2020 and 2022 respectively, even though the UK is no longer formally present at EU committees as of January 31st 2020.
- Clinical trials: the 2004 Regulations have been modified so they still apply to the UK after withdrawal from the EU.
Consequences of Brexit for industrial products: intellectual property, patents and trademarks
The ICEX, the Spanish institution for foreign trade, released a statement on the consequences of Brexit for industrial property last year. In the event of a no-deal Brexit, the EU regulations protecting these industrial property rights will no longer be effective, so any type of industrial property solely registered at the European Union Intellectual Property Office, and protected by geographical indication, will no longer be protected in the UK. If such property rights have previously been registered at the UK Intellectual Property Office, they will be protected.
As a result of Brexit, new regulations on exportation matters will need to be addressed. If you are encountering any doubts and need regulatory and/or linguistic guidance, contact us.
Check out the latest MDD & IVD EU Regulations here.