RESTON, Va. – As questions still swirl about what will happen with Brexit, experts speaking at the AAMI/BSI/FDA International Conference on Medical Device Standards and Regulations offered their take on the latest implications for the U.K. leaving the EU and how it will affect device makers.
At least one speaker during the conference – which was put on by the Association for the Advancement of Medical Instrumentation (AAMI), British Standards Institution (BSI) and the U.S. FDA – had a gloomy outlook, especially against the backdrop of the medical device regulations (MDR), which came into force May 26, 2017. Companies have a transition period of three years, and that butts against Brexit.
"I have a little bit, I guess, of a less optimistic picture of where we're at, and partly because . . . the EU status on a couple of things is less certain, and I don't see the mechanism moving forward to address the issues," said Joe Gatewood, VP of global strategy at the Advanced Medical Technology Association (Advamed), during the Brexit panel. For one, the number of notified bodies is falling, he explained, highlighting that there were more than 80 in 2012. That figure has dropped to about 50. Of note, the more niche notified bodies are being forced out, due to their inability to comply with the more complex regulation.
"There is no excess capacity in the system to address this issue," he emphasized.
He asserted that the EU has not moved at a pace and scale that was anticipated by the regulation to certify the notified bodies. "One notified body is authorized to do the new certifications necessary." The best estimates put 15 as being online as of the fall – that's out of 50 – with potentially 20 by the end of the year.
"That number could accelerate, but it's still not going to be even close to what is necessary," he said.
"Brexit exacerbates all of [the] problems, but because what happens is the U.K. is a leader in CE marking," Gatewood added, noting a particular problem in blood. "So, if you have a disruption with regard to Brexit, that takes more capacity out of a system that already doesn't have capacity," that's a problem.
Changes come quickly
While there are potential issues, there also are rays of hope – at least in the opinion of one presenter. "I think we are in a slightly better position than perhaps six or eight weeks ago," in terms of the transition and what that means for industry in terms of Brexit, said Gary Slack, senior VP, global medical devices, at BSI Group.
"From a practical perspective, I think it's highly likely now, given where we are, that the U.K. will end up in some kind of customs union-plus outcome from Brexit."
He noted that as late as three weeks ago, there was still a chance of a no-deal Brexit, but he thinks that is much less likely now. With that said, there are potential challenges the will have an impact on industry. For example, in a customs union, goods in free circulation are not subject to custom duties when moving within the union; however, customs declarations appear to be required and a value added tax is payable. Furthermore, U.K. imports benefit from European free trade agreements, but exports do not. Another complication is the evolving role of the notified bodies.
Slack proceeded with the assumption that a few things will happen over the next few months, including the U.K.'s likely participation in the EU elections in late May. "And I think we don't have any choice in that, and I think it's probably a good thing."
He added that he expected that a negotiated deal would trigger the original transition period through Dec. 31, 2020, with the Medicines & Healthcare products Regulatory Agency continuing to remain in the EU system until that date. In addition, the U.K. notified bodies would remain in the EU system through that time as well.
"There is some diminished influence, I will make that clear, that we're seeing as a notified body," he added. "We're not allowed to act as a . . . lead notified body from an influential perspective during that transition period, and we're already seeing some diminished influence." That applies to the regulatory authorities as well.
"We did have a contingency plan to move our customers to the Netherlands," he noted. "We have moved more than 4,000 certificates and 95% of our clients to [that country]." The organizations it has not moved primarily are focused on the U.K. only. This was done as a result of ongoing concerns of a no-deal Brexit.
BSI reported last November that it had achieved full designation as a medical device notified body in the Netherlands for the following directives: active implantable medical devices, medical devices and in vitro diagnostic medical devices. It is now accepting Medical Device Regulation conformity assessments in the U.K. "And we will continue to service U.K.-only focused manufacturers . . . for those that elected not to migrate."
Frank Fucile, senior director of regulatory affairs at Steris Corp., which focuses on sterilization, kicked off his presentation by asking how many in the audience thought they were ready for Brexit. A quick survey of the room saw that very few hands were raised.
Even if the chances of a No Deal Brexit are remote, most, if not all, device manufacturers already should have completed preparations in the case of this eventuality to minimize impact on their EU and U.K. businesses, Fucile said. The initial March 29 deadline should have served as an impetus. Now, those that are not ready still have time do so before Oct. 31. That is particularly important for companies using a notified body aside from BSI.
"Even under a soft Brexit with an extended transition period, there are still going to be changes that affect us all," he said.
On the commercial side, companies should store extra product inventory and/or the EU to ensure continued ability to supply. In addition, companies should establish a communications plan to inform internal and external stakeholders of Brexit-related plans.