Turn and face the strange: Adapting to regulatory changes

Ian Bolland caught up with Alan Finnerty, technology director at Medovate, to establish how the company is adapting to a changing regulatory landscape following Brexit. 

Distributing medical devices in multiple countries mean companies like Medovate have many regulations to consider. The UK’s new trading relationship with the European Union (EU) is one too, as firms operating in the UK will have to carry the UKCA mark – with a grace period available until July 2023. Currently, three notified bodies in the UK carry the new regulation: BSI, SGS and UL International.

In Medovate’s case, its SAFIRA device is certified under the Medical Device Directive (MDD), and with the EU transitioning to the Medical Device Regulation (MDR) in May this year, that particular grace period allows the company to continue with an MDD/CE mark until the middle of 2024.

Explaining the challenges the company faces, and how it aims to address them, Finnerty said: “Because of UKCA mark we will need to get that when the CE grace period finishes in 2023. We’re then going to submit for both UKCA and CE MDR at the same time. In terms of the documentation, UK MDR 2002 is the European MDD adopted into UK law. As it stands the technical requirements are no different but as soon as Europe transitions to MDR there’s going to be quite a gap between the UK regulation and European regulation. For us, the transition ought to be pretty smooth because both the UK and our SAFIRA CE documentation are already at MDD level.”

The gap that Finnerty refers to is one that he describes as “the biggest unknown” for medtech manufacturers. The Medicines and Medical Devices Bill will give the Medicines and Healthcare products Regulatory Agency (MHRA) the powers necessary to change the 2002 law. Finnerty believes more harmonisation and transparency between notified bodies would be positive and may make the UK an attractive investment proposition in the medical device sector. 

“I think in the UK if we were able to get greater clarity and greater harmonisation across the notified bodies that would assess the technical documentation that we would submit; and giving good, firm timelines, I think that would be really helpful to give manufacturers good confidence in timelines and costs, etc., to bring new medtech to market.

“One of the risks I see is that, if you’re a manufacturer based outside the UK and you’re looking at your market launch plan, you’re obviously going to go for US FDA or CE for Europe because you’d have access to large markets, and the UK and others would follow on thereafter. I think what we need to do is make the UK approvals process as least burdensome as possible, so the UK isn’t further down that queue in access to new medtech.”

Medovate also distributes its SAFIRA product in Australia, New Zealand and Israel. Finnerty suggested the approvals process in these countries is aided by already having accreditation from the FDA and CE mark. When discussing any divergence that may occur with the UKCA mark, he suggested a similar approach would be one of the least burdensome options to take.

“In our case we went with submitting our CE mark technical information to get approval – so we chose that route. 

“At the moment if a product only has UKCA mark, that route wouldn’t be available to a UK manufacturer – they would have to get the CE mark or US FDA approval to get approval in those three territories to sell their product.”

For those operating in Northern Ireland, there is the added complexity of the UKNI mark.

“For an overseas manufacturer, once they have a European notified body approval with CE mark they can sell into Northern Ireland. A UK manufacturer will need UK NI mark to sell into Northern Ireland or CE mark. It is more complex, and I think for us as a UK manufacturer, because we would go with BSI, they could award us both CE and UKCA or UKNI marks from single submission, so that would be least burdensome for us.

“Any medical device company that is not using a UK notified body who can do that will have to work with their existing non-UK notified body and its UK notified body to get access to the Great Britain market.”