The increase in Notified Body capacity in the UK is a positive step forward for the regulation of medical devices post-Brexit and the implementation of new European regulations. However, there is still more to be done to ensure a smooth clearance process for innovators.
In recent months, the UK has seen a notable increase in Notified Body capacity, with TÜV SÜD, Intertek, and TÜV Rheinland UK receiving Approved Body Status. This is a welcome development, as it allows for more life-saving innovations to enter the market and improve quality of life globally.
Prior to this approval, the UK had only four approved bodies, with UL International certified to approve in-vitro diagnostic devices. The increase in approved bodies almost doubles the capacity, which is undoubtedly beneficial. However, it is important to consider the capacity of each individual company, as this information is currently unknown until someone enquires about their services.
Elaine Gemmell from InnoScot Health has called for more resources and effort to be provided, stating that the three new approved bodies are not enough to bolster UKCA certification capabilities ahead of the CE mark transition deadline. The focus on this issue will only intensify, as CE marking is still allowed for device submissions to the British market.
The challenges surrounding Notified Body capacity, changing regulations post-Brexit, and the implementation of new European regulations are all interconnected and need to be addressed. The medical device sector requires certainty about the regulatory outlook, and more support is needed to ensure a smooth clearance process for manufacturers trying to bring their products to the UK.
Notified Body capacity is not just a UK issue, as the European system is also grappling with this challenge. Cross-border collaboration between new notified bodies operating in Europe and existing bodies could be a potential solution to ease the processes for everyone involved.
While the increase in capacity is a positive step, it remains one of the biggest challenges facing device innovators trying to bring their products to market. Additionally, keeping track of all the regulatory changes in the current environment is a significant challenge.
In conclusion, while there are signs of improvement and increased capacity in Notified Bodies, the clearance process for medical device innovators will continue to be challenging. More resources and collaboration are needed to address the interconnected issues and ensure a smoother regulatory landscape for all.