After four years, many heated debates, several delays, and a few Prime Ministers later, the United Kingdom (U.K.) is officially leaving the European Union (EU) today, January 31, 2020.
Well, sort of. Instead of the “hard Brexit” that had been promised and feared in March, April, and October of 2019, we will instead be entering this phase with a much-welcomed transition timeframe. The current transition allows for most things to remain the same for medical device manufacturers until December 31, 2020. During this transition year, you can continue to utilize U.K. based authorized representatives, European Union Notified Bodies, and sell CE marked devices that meet the EU medical device requirements including both Medical Device Directive (MDD) and Medical Device Regulation (MDR) compliant devices.
The most immediate change that occurs as of today is that the 73 U.K. parliamentarians from the 751-seat legislature will exit the EU, meaning the U.K. will no longer be part of the on-going legislative processes. The U.K. will also lose the ability to take the lead on reviews, so if you have a medical device with an integral medicinal substance, the Medicines & Healthcare Products Regulatory Agency (MHRA) will not be allowed to take the lead on that review. They may be able to participate on various committees but will have no voting rights.
As we learned from EU MDR, time flies not only when you’re having fun, but also when you’re in a regulation transition period – and trust us when we say that December 31 will be here before you know it.
For device manufacturers, here are the top five DO’s and DON’Ts to ensure an on-going ability to distribute your product in the EU:
- DO transition to an EU authorized representative if you currently have one in the U.K.
You will need to register your class I devices that were previously with MHRA with the new Competent Authority based on the location.
- DON’T underestimate the time it takes to get a new Notified Body.
If you have a U.K. Notified Body and have not yet transitioned to another office, the time is now to begin that process. With EU MDR implementation, the lead time to get a new NB is extensive.
- DO get yourself an EU importer, if applicable.
If you are using a U.K. based importer, you will need to arrange for an importer that is part of the EU.
- DON’T wait to review and modify your contracts.
If you need to modify your contracts with your NB and/or economic operators as part of Brexit, now is the time to make sure they are in alignment with the EU MDR requirements which is required by May 26, 2020, even if you are using the MDD soft transition period.
- DO sign up for e-mail notifications from the U.K. on the transition process.
And then actually open and read them when they hit your inbox!
Once you have taken care of making sure that you can continue to sell devices in the EU, you also have to consider what is required to continue to sell devices in the U.K. since this is now an independent nation with their own set of rules. As transition and trade deals are still in progress it is hard to define exactly what may be required. Luckily, there is guidance around a hard Brexit which provides some insight into how things may change moving forward:
• Potential U.K. responsible person with an address in the U.K.; note that at this time this name does not have to be added to the label.
• Separate registrations with MHRA; make sure you have a staff member identified to complete this requirement and watch the dates carefully.
• Continue to monitor guidance that are expected to be updated to reflect the transition negotiations as they occur.
We know that adding the Brexit transition timeline to your already full plate seems daunting but fear not! Along with your MDR transition, this too can be managed smoothly if you plan carefully and use the resources available to you to meet all new requirements. As always, R&Q experts are just a call or e-mail away if you have any questions or concerns about your company’s ability to stay on top of the ongoing changes in the European Union.
United Kingdom Government website. Medicines and Healthcare products Regulatory Agency. Guidance: Regulating medical devices in the event of a no-deal Brexit. Published February 26, 2019. Accessed January 30, 2020. www.GOV.UK
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