Medical devices in the UK are regulated by the directives put forth by the EU, including:
- Active Implantable Medical Devices Directive (AIMDD)
- Medical Devices Directive (MDD)
- In Vitro Diagnostic Medical Device Directive (IVDD)
High risk medical devices are certified by an independent conformity assessment conducted by notified bodies (NB). The notified bodies are overseen by the national authority of each member state in the EU, and by the Medicines and Healthcare products Regulatory Agency(MHRA) in the UK. NBs are also subjected to European commission audits.
Now that the UK is set to exit the European Union on March 29,2019, we are sure to see ripple effects in many industries. This will in turn disrupt the supply chain and the regulatory network for medical device manufacturers in the UK and the European union. If the UK is unable to subsequently adapt its regulations for market access and manufacturing of medical devices, then the patients in the UK will be deprived of high-quality medical devices for treatment and diagnosis.
Earlier in the year, the British Government released a white paper that addresses the future relationship between the UK and the EU. The white paper sets forth a common rule book in terms of goods manufacturing and trade. It proposes establishing free trade area for goods across borders (i.e. elimination of any tariffs for goods in the UK-EU region). The white paper also proposes that the manufacturers should only have to undergo one series of tests in the UK or the EU to gain entry in both markets. To support this proposal, the UK further states that the accreditation of the notified bodies should be done by a joint framework of accreditation. It also adds a notable point that the EU and the UK would continue recognizing the activities of one another’s approval authorities.1 However, this proposal was later rejected by the European commission.
If before the exit the EU and the UK are not able to propose a withdrawal agreement, then it will be called a ‘No Deal’ or a ‘Cliff Edge’ Brexit.
What this means for the Medical Device industry?
According to the notice released by the European Commission to the stakeholders of industrial goods in Jan 2018:2
Marketing in the EU
The UK will be considered as a ‘third country’ after the ‘no deal’ Brexit. This means that distributors and manufacturers of medical devices located in the UK will be given an ‘importer’status and will have to comply with the regulations applicable to an importer from any other country.
Medical Device manufacturers from across the globe, with an authorized representative (AR) in the UK, will have to consider switching to an EU based AR. Also, after the Brexit, UK based manufacturers will have to establish EU based AR’s. Thus, a resounding financial and logistical impact is going to exert additional pressure on the Medical Device industry.
In addition, UK based NB’s will lose their status as an EU notified body and will no longer have the permission for conformity assessment and will become unable to issue certificates for devices in the EU market. This move will impact the medical device manufacturers in that their current CE marks that were granted by a UK based notified body will now have to be transitioned to a notified body in one of the 27 European member states, or the manufacturers will have to transfer their certificates and the technical documents to an EU based NB on a contractual agreement to market their device in Europe.
Marketing in the UK
The British Government released guidance for the medical device industry in case a no deal is struck before the Brexit. It further states that the release of the guidance is only a step in their preparation for a no deal scenario and does not in any way imply the confirmation of a no deal outcome.
According to the guidance document, the UK will continue to recognize the medical devices approved for the European market for a limited time period and will continue to follow the European regulations for medical devices, including the MDR and the IVDR which will become effective in 2020 and 2022 respectively. The UK will continue using the GxP guidelines as issued by the European Commission. In a scenario where the post market surveillance data which is currently shared between the European regulatory network becomes unavailable to the UK because of a no deal, the MHRA would take the charge of performing post market surveillance and making marketing decisions in the UK.3
All the regulatory submissions such as marketing authorization (MA) applications, device registrations… etc. will need to be submitted to a national portal, which the British Government will release more information on in the future. However, the British Government did loosen the burden on the stakeholders by stating that the UK will continue to accept EU application forms and eCTD (electronic common technical document) for submissions.4
The Health and Social Care Committees of the UK sent out a report to the British Government with concerns and recommendations on the regulatory arrangements in the UK after the Brexit. It is a bit of a relief to know that the UK and the EU negotiating teams have reached an agreement on the terms of an implementation period that will start on 30 March 2019 and last until 31 December 2020. During the implementation period, the UK will no longer be a Member State of the EU, but market access will continue on current terms; stated the response from the Government.5
The Committee report suggested that if full regulatory connection with the EU is not secured, then it would be preferable that the UK establishes a standalone regulatory system, or a second-best option could be an alignment with the US-FDA; however, this has the potential to create greater financial and public health ramifications.
The Government responded to this recommendation by stating that “Our door will always be open to a deep and special relationship with the EU which remains the best way to promote improved patient outcomes both in Europe and globally. We will support global initiatives like the Medical Devices Single Audit Program, which aims to minimize duplicative regulatory inspections of individual manufacturers”.6
The Committee also expressed concerns on the supply chain issues and asked the Government to set up a contingency plan to maintain the supply chain of medicines and the devices in the UK.
In conclusion, Brexit poses huge challenges to the medical device industry and carries several unintended consequences for patients in the UK. A “no deal” Brexit would further mean a massive burden on device manufacturers to adhere to the new regulatory system set up by the UK in the future.
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1HM Government, UK (July 2018). The future relationship between the United Kingdom and the European Union. Retrieved on 11-06-2018 from https://assets.publishing.service.gov.uk/Government/uploads/system/uploads/attachment_data/file/725288/The_future_relationship_between_the_United_Kingdom_and_the_European_Union.pdf
2European commission, Brussels (Jan 2018). Notice to stakeholders- Withdrawal of the United Kingdom and EU rules in the field of industrial products. Retrieved on 11-06-2018 from https://ec.europa.eu/info/sites/info/files/file_import/industrial_products_en_1.pdf
3HM Government, UK (September 2018). How medicines, medical devices and clinical trials would beregulated if there’s no Brexit deal. Retrieved on 11-06-2018 from https://www.gov.uk/Government/publications/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal
4HM Government, UK (September 2018). Submitting regulatory information on medical products if there’s no Brexit deal. Retrieved on 11-06-2018 from https://www.gov.uk/Government/publications/submitting-regulatory-information-on-medical-products-if-theres-no-brexit-deal/submitting-regulatory-information-on-medical-products-if-theres-no-brexit-deal
5HM Government, UK (May 2018). Brexit: medicines, medical devices and substances of human origin: Government response to the Health and Social Care Committee’s Fourth Report of Session 2017-19. Retrieved on 11-06-2018 from https://www.parliament.uk/documents/commons-committees/Health/Correspondence/2017-19/Government-response-to-Brexit-medicines-medical-devices-and-substances-of-human-origin-report-2017-19.pdf
6HM Government, UK (May 2018). Brexit: medicines, medical devices and substances of human origin: Government response to the Health and Social Care Committee’s Fourth Report of Session 2017-19.(pp.7) Retrieved on 11-06-2018 from https://www.parliament.uk/documents/commons-committees/Health/Correspondence/2017-19/Government-response-to-Brexit-medicines-medical-devices-and-substances-of-human-origin-report-2017-19.pdf