MHRA preparing to deploy IRF for medical devices

According to Richard Phillips, executive director of the Association of British HealthTech Industries (ABHI), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is preparing to deploy an international recognition framework for medical devices that would allow device makers to bring products to the UK more easily.

Phillips made these remarks at the 2024 Medical Device Manufacturers Association (MDMA) Annual Meeting on 19 April. Earlier this year, MHRA replaced its European Commission Decision Reliance Procedure (ECDRP) with a new International Recognition Procedure (IRP) for pharmaceuticals that allow the agency to rely on decisions by select international reference regulators, including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada, Swissmedic, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

Phillips noted that the Chancellor of the Exchequer Jeremy Hunt last year said MHRA would use a “rapid, often near automatic sign-off” system to allow medical products on the UK market if those products were already authorized by regulators in select jurisdictions. He also referenced a blog post from Laura Squire, MHRA’s chief healthcare quality and access officer, from March that indicates that the agency would publish a proposal for international recognition for medical devices this spring.

“In the next year or so, prepare to bring your FDA approvals to the UK,” said Phillips. “What we are wrestling with is how we do regulation as a nation now outside of the EU. One of the routes for the UK market will be a route of international recognition.”

He added that MHRA is currently accepting CE marking unilaterally, and for certain products, it is doing so indefinitely.

“At the moment, what we’re trying to do is figure out what that might look like,” said Phillips. “If you’ve got a PMA, that’s one thing. If you’ve got 510(k), that’s something else and you may need to bring some other things to the table.”

While he said European regulators don’t like the idea of using an equivalence model to regulate products, MHRA has been studying the US regulatory regime and is advocating for trust in the FDA’s review integrity.

“We make the point that this is the FDA right? It’s not some backwater somewhere that’s in the habit of putting their unsafe products out onto its litigious populations,” said Phillips. “We should have some more details next month. We’re promised a framework for what international recognition might look like. That’s one to watch out for.”

Phillips told Focus that the idea of relying on FDA authorization decisions was initially not taken seriously because Brexiters were concerned with maintaining the UK’s regulatory sovereignty. As a result, he said the UK accepted CE marks as an interim measure, which has seen “remarkably little” dissent, and even hardcore Brexiters argue that taking back control over British sovereignty is about what regulations to accept.

As MHRA has shrunk in size after Brexit, Phillips said the government is grappling with how to efficiently use its resources to ensure proper oversight of products entering the market. Considering that about 80% of the content in regulatory filings is the same regardless of where the application is being filed, he said the UK needs to be pragmatic about how it regulates products.

“We’re not going to be able to ever produce a UK FDA-type model, even if we wanted to,” said Phillips. And if we could afford it, we probably won’t be able to recruit people to do it.”

Philips said companies should pay close attention to MHRA’s updates on the international framework and added that companies with 510(k)s should start thinking about what postmarket data MHRA may ask for under a reliance framework and prepare accordingly.

“Think about how you can collect data once it’s on the market in the UK, and who you might be wanting to partner with,” he said. “There are all sorts of networks you could probably tap into in the UK that could help you with that once we know the additional stuff you’re going to need.” RAPS.org