What is a class IIb medical device?

According to the Medicines and Healthcare products Regulatory Agency or MHRA, class IIb devices are generally regarded as posing a medium risk to users.

Because of their inherent risk, class IIb device manufacturers must comply with various regulations to ensure patient safety & data security and privacy.

For more information on this feel free to check out our free CPD certified course on digital therapeutics in the UK, found on our course website.