The Medicines and Healthcare products Regulatory Agency or MHRA, is responsible for regulating medical devices in the UK, to ensure they work and are safe to use.
Whilst initially meant to regulate physical devices, this agency is also responsible for regulating digital solutions like digital therapeutics, which under current legislation also classify as medical devices.
In the EU, the situation is slightly more complex. Until recently, medical devices in the EU were regulated under the Medical Devices Directive (MDD) which came into effect in 1993. Considering digital therapeutics didn’t exist back then, MDD is being replaced by MDR which is a new set of regulations.
In addition to improved transparency and traceability of devices,MDR 'provides additional rules on clinical evidence and post-market surveillance, greater regulatory oversight from notified bodies and a more stringent pre-market security mechanism.'
So how do you know if the device or app you are using is compliant with these regulations?
In practical terms, users can check if it has a CE marking, this signifies compliance with MDD requirements and means the device is safe to use in Europe.
As MDD transitions to MDR, the CE marking will remain constant and companies undergoing the transition will re-apply for a new CE marking which complies with the updated regulations.
In the UK the UKCA, (introduced due to Brexit), has fully replaced the CE marking after the transition period ended on the 30th June 2023. It should be noted that the requirements for the UKCA marking will be very similar to those required for the CE marking, so if a device is compliant for one it is most likely compliant for the other.
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