How could a no-deal Brexit affect my medical device lifecycle?
The full implications are still unclear, however it is a stressful time for UK manufacturers and sponsors of medical devices as companies face harsh penalties for violating EU law if they don’t comply; yet they still need to meet business obligations to stakeholders, clients and patients. The political and legal situation is still evolving, and this uncertainty raises many questions for the device development pathway.
Highlight: Unless a deal is reached, the UK will be classified as a “3rd country” (i.e. become its own country) in the device regulation world, creating a fallout of other challenges related to maintaining and obtaining CE marks, manufacturing devices and running clinical device trials in the EU.
What can you expect from the medical device development team at Covance in preparing for Brexit?
Covance is monitoring the political situation in the UK and preparing for all possible outcomes, including a no-deal Brexit. We are committed to supporting our clients and their medical device products—whatever the product’s development stage—and keeping company pipelines running as smoothly as possible.
What is a key legal implication for device development under Brexit?
The significant legal implication is that as of 30 March 00:00h, the United Kingdom will become a “third country” in the eyes of the EU. This change means that CE marks from UK Notified Bodies will no longer be recognized by the European Union. UK medical device manufacturers who place their products into EU markets will now be classed as economic importers instead of EU distributors.
The European Commission sent out a notice to industrial product stakeholders on 22 January 2018 stating:
The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the EU. This means that, unless a ratified withdrawal agreement establishes another date, all EU primary and secondary law will cease to apply to the United Kingdom from 30 March 2019, 00:00h (CET) ('the withdrawal date’).1
How will a no-deal Brexit impact medical device CE marks issued in the UK?
If your “conforming with Europe” mark (i.e. the CE mark) has previously been issued by a Notified Body (NB) located in the UK—and the UK becomes a third country—you will need a certificate (or a new CE mark) delivered by a NB that is recognized as an EU NB to continue placing your medical devices on the market.
If this is the case for your medical device, consult with an EU-27 Notified Body to transfer the CE mark or submit the technical file / technical file dossier before the withdrawal date. Be sure to also update your EU Declaration of Conformity (developed by the manufacturer) document with your certificate numbers. (You will indicate both the UK NB number as well as the new EU NB number.)2
Bear in mind that with the new Medical Device Regulations (MDR) there is a requirement that the Notified Body be accredited under the upcoming MDR. Currently 35 NBs have applied for the accreditation so make sure you submit to a NB that has already applied to and is most likely be certified. Interestingly, the only accredited NB under the new MDR is located in UK and CE Marks from this NB will be no longer accepted by the EU-27 after the UK withdraws from the EU.
A full list of EU Notified Bodies can be found in the Nando Database, which guides you to the UK Notified Bodies.
How will a no-deal Brexit impact products manufactured in UK and shipped to EU?
If the medical device is manufactured in the UK, and the UK becomes a third country, an authorised representative for the manufacturer needs to be established in the European Union.1
The 22 Jan 2018 notice further explains the new importer role as such:
According to Union product legislation, the importer is the economic operator established in the Union who places a product from a third country on the Union market. As from the withdrawal date, a manufacturer or importer established in the United Kingdom will no longer be considered as an economic operator established in the Union. As a consequence, an economic operator established in the EU-27 who, prior to the withdrawal date, was considered as an EU distributor will become an importer for the purposes of Union product legislation in relation to products from a third country that this economic operator places on the EU-27 market as from the withdrawal date. This operator will have to comply with the specific obligations relevant to an importer, which are different from those of a distributor.
What is the potential impact for a UK device sponsor/manufacturer conducting clinical trials in the EU?
If the sponsor of a medical device clinical trial is in the UK, and the UK becomes a third country, a legal representative needs to be established in the European Union in order to conduct the clinical trial in the EU.
Where does your responsible person (i.e. authorised / legal representative) need to be based?
According to the clarifying Q&A documents, any UK-based authorised or legal representatives will lose their status on the withdrawal date. All manufacturers need to ensure that their responsible person is “established in the EU” before 30 March. 2
What is the difference between an “authorised representative” for manufacturers and a “legal representative” for sponsors?
Medical devices are governed by Directives and medical device laws in the EU. The EU Directives, such as Directive 2007/47/EC refer solely to a product manufacturer’s “authorized representatives” and in this directive, any reference to clinical trials is included in the responsibility of the “manufacturer.” (The word “sponsor” doesn’t even appear in the legislation.) The legal representative requirement is outlined in the medical device laws of each country.
Regardless of whether you have a separate authorised representative for manufacturing from your legal representative for clinical trials, the principle is the same: representation now needs to be based in the EU.
Note: The directives have been translated into medical device laws in March 2010 for each EU country, so those are the binding requirements we must comply with. The German Medical Devices Act (English translation) requests for a “representative of the Sponsor” in the EU if the Sponsor is located outside of the EU (§ 20 (1) no. 1a German MPG). The Austrian Medical Devices Act (§ 3 no. 5 Austrian MPG) does not specifically provide a definition for the legal representative, nevertheless the Austrian CA clarifies in their guidance document for clinical trials with medical devices on their website that the legal interpretation is in analogy to that of the medicinal product legislation: “§ 2a (16) AMG (Austrian Medicinal Products Act): Sponsor is a natural or legal person who takes responsibility for the planning, initiation, management and financing of a clinical trial. The sponsor or his legal representative have to reside in a signatory party of the EEC.”
What can Covance do to help you navigate Brexit changes?
Our Covance Global Regulatory Submissions (GRS) Team can identify for each ongoing clinical investigation the requirements for every participating country and can submit, on your behalf, the substantial changes to the authorities and ethic committees. This includes changes, such as switching the CE mark from an EU-27 Notified Body mentioned in this article. There are also potential changes that impact the labeling of medical devices and its associated documents (i.e. IB, IFU, informed consent), which we can help with. And finally, we are also able to consider acting as your legal representative for the purposes of conducting clinical trials if you wish.
Conclusions and outlook
As the reality of a no-deal Brexit increases in probability, Covance has created task forces to work with our device clients on a case-by-case basis to ensure each sponsor is prepared for any probability. Despite the uncertainty of Brexit, we are committed to supporting our UK medical device clients and assisting them with their unique circumstances and individual concerns
We are confident that through understanding the legal situation and implementing appropriate risk mitigation strategies our UK clients can continue business with the EU and bring new medical devices to market.
If you would like to speak with one of our device leaders, please contact us.
1 European Commission: 22 January 2019, Notice to Stakeholders: Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products
2 European Commission: 1 February 2019, Questions and Answers Related to the United Kingdom’s Withdrawal From the European Union With Regard to Industrial Products
Update: 15 March 2019
Covance continues to monitor the changing political situation in the UK and remains prepared for all possible outcomes, including a no-deal Brexit.
On 14 March 2019, the House of Commons passed a motion to extend Article 50 beyond 29 March 2019. The motion laid by the government states that if the withdrawal agreement is passed on 20 March, the prime minister will seek to delay UK withdrawal from the EU until 30 June. If the withdrawal agreement bill is not passed, a longer delay will be sought.
The regulatory requirements for medical device manufacturers as outlined above have not changed, and a delay to the Brexit process is not guaranteed; however, if the withdrawal is postponed, our clients will have more time to comply with new requirements. Please contact us if you have any concerns about your project.