No-deal Brexit: Key Questions for Medical Device Companies
Regulatory Updates | In-Vitro Diagnostic Devices, Medical Devices
With Brexit Day now just a month away, medical device companies active in UK and European markets should be mapping out the impact of a no-deal Brexit on their operations.
Following Emergo by UL’s recent webinar on a no-deal Brexit’s impact on the medical device industry, we discuss some key questions many manufacturers are facing.
How would a no-deal Brexit affect REACH in the UK?
The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation is part of the EU requirements for placing products on the EU Single market. If the UK leaves, those rules do not automatically apply. However, British authorities have indicated they will make EU laws into UK laws. That means that legislation such as the REACH and ROHS will also apply in the UK. They will be supervised by UK authorities and interpreted by UK judges.
Are you aware of plans for any kind of triage system for trucks moving in or out of the UK, so that certain shipments such as medical products can be prioritized?
In a way this can be expected as the UK is trying to organize special ferry services for emergency goods. However, I don’t how they think they can organize that. Those trucks need to be singled out from the lines of waiting trucks. That means that someone with a certain authority of checking the contents of a truck needs to be available for checking trucks in those pile-ups, and then these trucks somehow need to be able to move to a specific point so they can get on board. I don’t expect this will work.
What would be the impact on vigilance reporting and FSCAs of a no-deal Brexit? This is for cases that potentially cross the hard border.
This is a rather complex question to answer. Let’s look as some scenarios for incidents happing after Brexit Day:
1. An incident happens in Europe with a device from a European manufacturer or a non-EU manufacturer using an EU-based Authorized Representative. Parties determine that a Field Safety Corrective Action (FSCA) is required. This FSCA is also carried out in the UK. The manufacturer reports the incident to the national Competent Authority (CA) of the Member State where the incident happened, and also informs them about the FSCA. All Member States involved in the FSCA will be informed. This manufacturer should also inform the UK CA, MHRA. However, MHRA will be cut off from European networks and databases in which these cases are handled, so the agency will not know about it until notified directly by the manufacturer. EU data on this FSCA will also not be shared with MHRA. The manufacturer will have to report this case to the MHRA as if it were a EU case. MHRA will then draw its own conclusions, but will not be able to communicate that with the EU authorities.
2. An incident happens in the EU with a device from a UK-based manufacturer, or non-EU manufacturer using a UK-based AR, that has been placed on the market before Brexit. After investigating the incident, the manufacturer decides to issue an FSCA. In this case the device is not represented by an E- based legal person. The incident should be reported to the CA in the Member State where the incident happened. This CA will take the lead in the FSCA. They will reach out to the UK-based manufacturer. If this is not successful, this may indicate the device is not sufficiently represented on the EU market. EU authorities cannot formally reach out to MHRA to require action. They may decide the device must be recalled from the EU market (current article 8 procedure). For cases in which a device placed on the market by an EU-based manufacturer/AR with an incident in the UK, the situation is similar: the EU cannot formally be approached, and may not act.
3. An incident happens with a device placed on the EU market after Brexit by a UK-based manufacturer, using an EU-based AR, where the incident results in an FSCA. From an EU perspective this is fully covered, because this would be treated the same way as for a device placed on the EU market by any non-EU manufacturer. UK citizens may be kept exposed to a device with an issue, because MHRA is no longer part of the EU vigilance system.
In case of a no-deal Brexit, would the MDR still be implemented in the UK?
We will see the current directives becoming UK law and it is highly likely this will also happen with the Regulations. Of course there will be some differences regarding CE Marking, the functioning of Notified Bodies and the roles of the European Commission, MDCG and European Court of Justice. So far Emergo by UL has not seen any information on how that will be organized in the UK.
For UK-based manufacturers with UK Notified Bodies, how likely will it be that European authorities block imports from the UK on Day One of a no-deal Brexit? And what about devices made in the UK that are currently marketed in Europe?
This is a very difficult question to answer. On the one hand, these are devices that are no longer in compliance with the requirements and they should be kept off the market. On the other hand, currently they are in compliance and they can be used safely. Immediately after Brexit Day there is only an administrative difference, and therefore it will be very difficult to explain to European citizens what the difference is. Apart from that, there are some practical issues. There will probably not be enough time for doing these border checks, and if this would happen and be effective, this might disrupt the continuity of care. Such disruption could be blamed on Brussels’ bureaucracy and it is likely the authorities would rather not want to see that.
The short answer to this question is: nobody knows.
Are there any solid timelines as to when manufacturers can start appointing UK REPs?
There is not a starting date mentioned, but it is necessary to have one designated after Brexit. Emergo by UL therefore thinks it is best to start this now. We have a “delayed start” option for this service that implies that all will be prepared and this agreement kicks into force at the moment it is needed. Until then the manufacturer is still operating under current EU rules.
Will current self-declarations under the IVDD enable IVD products to stay on the market during the MHRA’s transition period?
It is highly likely MHRA will use the same transition period as the EU for these products. That would imply self-certified IVDs can remain being placed on the market in parallel with the current IVDD.
Does MHRA plan to publish any new registration requirements to obtain import approval into the UK? How will any new requirements affect supplies and access to medical devices in the UK?
For now we have to do with these guidelines. But Emergo by UL expects that in case of a no-deal Brexit more will be published in the months to follow. For now we know that devices need to be registered by the UK-based manufacturer or the UK REP, but the details of how to do this and what is exactly required are not yet clear.
After the withdrawal date, will there be a transition period in the EU for companies to make required changes to labeling?
At this moment no transition period is mentioned. However, it can be expected that for practical reasons there will be some sort of transitional period. It is not clear how that will work out in practice.
Learn more about Brexit and European medical device regulatory issues:
- Brexit transition consulting and in-country representation support
- European Authorized Representation in-country representation
- European MDR gap assessment and CE Mark transition strategy
- Whitepaper: Preparing for a no-deal Brexit
- Webinar: Impact of a no-deal Brexit for medical device companies