With less than one month to go before the the Brexit deadline and the UK government still scrambling to strike a deal with the European Union that all signatories can live with, stakeholders in the medical device manufacturing supply chain are asking many questions but not getting many meaningful answers. Regulatory affairs consultancy Emergo recently published an article that airs some of their concerns, “No-deal Brexit: Key questions for medical device companies.”
One question that medtech companies are wrestling with in their “what-if” scenarios, according to Emergo, is the status of UK-made devices notified by UK-based bodies on day one of a no-deal Brexit. “This is a very difficult question to answer,” writes Ronald Boumans on the Emergo website.
These devices, he notes, are currently in compliance and can be used safely. On the other side of the Brexit deadline without a deal, however, they are technically no longer in compliance with CE marking requirements and should be kept off the market. On the other hand, explains Boumans, “there is only an administrative difference and, therefore, it will be very difficult to explain to European citizens what the difference is.”
The article also explores Brexit's potential impact on post-market vigilance reporting and compliance with EU regulations such as the Medical Device Regulation and REACH.
In addition to issues related to the export of medical devices, the UK also could face dramatic fallout involving imports of medical products. The Guardian newspaper reported recently that a hospital executive in Birmingham said that “he could not envision any scenario whereby a no-deal Brexit does not significantly affect patient safety.” Dr. David Rosser of University Hospitals Birmingham NHS foundation trust predicts that the “[National Health Service] could quickly run out of vital medical supplies. In terms of the potential for major operational impact and severe and widespread risks to patient safety, by far the greatest concern is the availability of medicines, devices and clinical supplies,” Rosser wrote in a memo to the university hospital’s board of directors, reported the Guardian.
The short answer to how all of this and much more will play out on March 30—the UK is scheduled to leave the EU at 11 PM UK time on March 29—contains the two words that businesspeople fear most: Nobody knows. That's how Emergo's Boumans concluded his thoughts on the compliance of British-made devices on the EU market after the Brexit deadline, and it's essentially true across the board.
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