March 1, 2019
No-deal Brexit Scenario: What Will Happen With The Medical Device Industry?
With 30 March 2019 approaching, the possibility of a no-deal Brexit is still very likely. What happens if a no-deal Brexit occurs? At Factory-CRO we have been thinking a lot about that scenario. Below are six key areas to consider if there is no deal and how it will impact the medical device industry.
The United Kingdom (UK) will be classified as a ‘Third country’ in the case of a no-deal Brexit. Meaning, the transfer of personal data to and from the UK will classify as the transfer to a non-European Union (EU) member state. According to the EU General Data Protection Regulation (GDPR), several ‘appropriate safeguards’ need to be in place for data transfer to Third countries. This may impact regulatory processes, clinical trial agreements or acquisition of study data. Severity of this impact depends on the type of data, location of involved parties, GDPR compliance of the involved parties, etc. Therefore, organisations that participate in (clinical) data transfer activities to and from the UK should carefully assess this impact, and be prepared to take additional measures.
Industrial Products/ Medical Devices
If the UK becomes a ‘Third country’, identification of economic operators (organisations that supply goods, work or services related to market operations) will change. For example, an economic operator established in the EU may currently be identified as a distributor of medical devices, while after the 29th of March the same distributor may be identified as an importer. The identification as an importer has, according to EU regulations, the responsibility of complying with different specific obligations as compared to a distributor.
Authorised Representative/Responsible Person
For specific products (including medical devices), EU legislation obligates an Authorised Representative (Responsible Person for cosmetic products) to be established in the EU. May the Authorised Representative be established in the UK after the 29th of March 2019, then the EU will not recognise the Authorised Representative in case of no-deal Brexit. Organisations operating in the EU with Authorised Representatives located in the UK should therefore closely look at the impact of a no-deal Brexit and prepare for its consequences (e.g. relocation of the Authorised Representative). On the other hand, it is important to realize that after a no-deal Brexit a manufacturer of a medical device on the UK market needs to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) through a ‘UK Responsible Person’, who is established in the UK (including an UK registered address). This ‘UK Responsible Person’ will take accountability for the product in the UK. Some consolation is there will be no labelling changes required to reflect the role of the ‘UK Responsible Person’.
Current UK regulations concerning medical devices are aligned with EU directives. Meaning, the EU Directives AIMDD 90/385/EEC, MDD 93/42/EEC and IVDD 98/79/EEC are transposed into UK law: Medical Devices Regulation 2002. In case of a no-deal Brexit, the MHRA will take responsibility for medical device regulation for the UK market. The MHRA issued a statement that the EU MDR & IVDR will be mirrored into UK regulation, including the usage of the EU issued transitional timetable for implementation. Important to know: the MHRA indicated that in case of a no-deal Brexit, medical devices in conformity with EU Directives can be placed on the UK market for a “time-limited period”.
The EU requires Notified Bodies (NBs) to be established in a Member State. In case of a no-deal Brexit, NBs located in the UK will no longer be recognised by the EU. Certificates issued by UK-based NBs will no longer be valid, and it is advised to either apply for a new certificate with an EU-based NB or arranging a transfer to a NB located in the EU. Considering the Brexit is due end this month; if you’re not already in the process of re-applying or transferring, you will most likely be too late already. BSI-UK is currently working hard to transfer their certificates to BSI-NL, whether they will be able to transfer all their certificates before the end of March is however doubtful.
The UK itself will continue to recognise UK-based NBs, meaning products covered by UK-based NBs are allowed to be placed on the UK market. For pre-market access products, registration with the MHRA will be required prior to market access.
“Organisations and companies involved in data transfer, clinical operations and conformity assessments in the UK should carefully look at the impact of a no-deal Brexit.”
Jurriaan Sombeek – Factory CRO
The current available information outlines no significant changes to clinical investigations. The UK will continue to recognise existing Ethics Committee and regulatory approvals, there is no need for re-applying. UK clinical investigations will continue as they are presently.
In conclusion, a lot will change for the medical device industry in the scenario of a no-deal Brexit. Imperatively, medical device manufacturers, Authorised Representatives, Contract Research Organisations and other stakeholders should prepare for such a scenario. The 12-14 of March will be key for how the Brexit is going to be shaped as British Parliament votes for a deal, no-deal or transition period extension.
So, be prepared for the leaving of our British friends and colleagues without a deal!
If you have clinical trial related questions as these changes with no-deal Brexit occur, we are here to help you. Please do not hesitate to reach out to us for your comments and questions at www.factory-cro.com.