UPDATE: Jan. 16, 2018: Britain's government voted 432 to 202 Jan. 15 to reject Prime Minister Theresa May's proposed exit deal. Parliament will debate a vote of no confidence Jan. 16 that could jeopardize May's position.
UK regulators recently updated guidance for medtech companies on what to expect if there is no deal when the country leaves the European Union on March 29. Under such a scenario, the closely knit regulatory frameworks of the EU and UK would dissolve and the UK would have to develop its own set of rules and requirements for registration, vigilance, clinical trials and compliance.
Manufacturers would need a notified body registered in the UK to certify products for sale in that country and a second notified body registered in an EU member state to register products in the EU.
The increasing likelihood of a no-deal Brexit — Britain's parliament is slated to vote on an unpopular deal reached by Prime Minister Theresa May and EU officials in November — has companies awash in uncertainty, particularly over what will happen to their products in the EU.
A key concern has to do with the logistics of manufacturing and operations to ensure products continue to reach the patients and providers who need them. Another is the potential drain on available talent, research and personnel as borders close and the regulatory landscape shifts.
"Companies are working diligently to minimize disruption to their business, from auditing supply chains to addressing the possible outcomes for each of the future trade models," Phil Brown, director of technical and regulatory matters at the Association of British Health Tech Industries, told MedTech Dive in an email.
Manufacturers also worry that regulatory fees could rise without a deal — especially worrisome in an industry dominated by small- and mid-size companies. A no-deal scenario would no doubt increase the MHRA's workload, particularly in areas like vigilance and registration. The biggest impact will be on notified bodies, which are already scrambling to meet increased demand for conformity assessments due to the MDR transition.
Notified body quandary
The acceptance of UK notified bodies as part of any arrangement would be a major plus, allowing for the smooth transition of notified bodies and product certifications.
This is not the time to be looking for a notified body in the EU, according to Elisabethann Wright, a partner in Hogan Lovells' Brussels office. With the EU's new medical device rules coming into effect in May 2020, the number of available notified bodies is already diminishing.
At least one UK notified body has applied for a license to practice in the Netherlands, enabling clients to transfer conformity assessment certificates, the basis for CE marking, from the UK entity to the Dutch entity. That can be costly, though, and not just for the transfer process. Companies that do this will need to relabel all of their products because the license number of the notified body will change, Wright notes.
Companies that are starting over with a new EU-based notified body face not just relabeling costs, but a new conformity assessment and possibly a new ISO 13485 (quality management) certificate.
It's a huge investment, and manufacturers are loath to take the plunge if a Brexit deal is still possible.
"This is the problem, the big ‘if,'" Wright told MedTech Dive. "When do you decide, 'I can't keep putting this off anymore? I need to find a new notified body, or I need to transfer my license to the Dutch notified body? I need to start taking steps to relabel my devices.' It's a very unfortunate game of regulatory poker, because if you do do it, you may find that it was an unnecessary investment, but if you don't do it, you may be out of the market."
MHRA guidance
The UK's latest guidance for medtech manufacturers, issued by MHRA on Jan. 3, is aimed primarily at companies based outside the UK, which would need a UK notified body to register products there under a hard Brexit. The MHRA will give companies four to 12 months to transition their CA certificates, depending on the device's risk level.
"What the MHRA is proposing would undoubtedly be beneficial … for the movement of devices from the EU to the UK," Wright allowed. The big question is "how will UK devices get onto the market in the EU," she said.
The guidance also covers conformity, clinical investigations and market surveillance.
While not directly related to workload, the issue of vigilance is could have a broader impact due the UK's membership in EUDAMED, the European database on medical device information.
"I would argue that this is … not necessarily an issue for vigilance per se, but more for patient safety," Brown wrote in an email. "Outside the EUDAMED process (as we will be without a deal) will mean a pan-European reporting system without the UK input which is recognised as significant, thereby diluting the effectiveness of EUDAMED itself."
In the event of a no-deal Brexit, MHRA would perform market surveillance of devices in the UK and make market determinations, regardless of the EU position.
If there's a bright spot in the fog, it is that, deal or no deal, the UK plans to align with the new EU medical device and IVD regulations and their transition timetables — May 2020 for MDR and May 2022 for IVDR. That could help to smooth the process of registering in both domains, if it comes to that.