A new route to clearance?

In his editor's letter, Ian Bolland comments on the increase in Approved Body numbers in the UK.

Whenever I have had the opportunity to discuss regulation of medical devices with those who know their stuff on the issue, there have been several consistent themes: Changing regulations in the United Kingdom post-Brexit, grappling with the new European Medical Device and In-Vitro Diagnostic Regulations, and Notified Body capacity.

The UK has made what seems to be a welcome step forward on the latter of late with a notable increase in Notified Body capacity with TÜV SÜD, Intertek, and TÜV Rheinland UK receiving Approved Body Status.

Prior to this approval in August, the UK had a total of four approved bodies in BSI, Dekra and SGS, with UL International only certified to approve IVDs.

While the MHRA welcomed approved body capacity almost doubling, and the increase in capacity is undoubtedly welcome as we try to get more life-saving innovations on the market to improve quality of life across the world, one thing to consider is the capacity that the individual companies have. This is likely to be an unknown until someone enquires about their services, but their presence might well break a bottleneck for approvals but there is still more to be done.

Elaine Gemmell from InnoScot Health wrote for the Med-Tech Innovation News website calling for more resources and effort to be provided:

“There’s no doubt in my mind that these additional Approved Bodies are much needed and will bolster UKCA certification capacity following Britain’s legislative cut-off from Europe during Brexit. It is also positive that EU Notified Bodies TÜV SÜD, Intertek, and TÜV Rheinland UK are being designated as UK Approved Bodies, demonstrating confidence in our system.

“But with CE marking still being allowed for device submissions to the British market, three new Approved Bodies is not yet enough to bolster UKCA certification capabilities ahead of the CE mark transition deadline, and the focus on that will only continue to intensify.

“It is simply not sufficient to support manufacturers who are trying to bring their products to the UK.”

As you can tell from Gemmell’s comments – the big issues are all linked and need addressing. If I had a pound for every time I’ve heard there needs to certainty about the outlook for regulation in the medical device sector, I probably wouldn’t bit sitting here writing this column and I’d be putting those proceeds into trying and failing at another career as a professional golfer.

It's positive news but there is more that must come along for the clearance process to be smooth as possible for any innovators.

Capacity, of course, isn’t just a UK issue, it’s something that is grappling the European system too, with the new notified bodies also operating in Europe (much like the existing bodies) maybe some cross-border collaboration might be the next step in easing the processes for everyone.

While capacity may have increased, and it remains one of the biggest challenges facing device innovators getting their product to market, keeping track of all of the regulatory changes in the current environment remains a big challenge. Indeed when attending a session at Medilink Midlands Innovation Day, delegates suggested it remains the biggest, but approved body capacity was mentioned.

This area is going to be challenging for some time yet, but at least there are signs that innovators lives may get easier in one aspect.