ORCHA is not a notified body for the purposes of the Medical Device Regulations. Our review process, therefore, uses the guidance provided by MHRA to assess whether an app falls under the definition of a medical device. Where we consider it does and no CE mark is present, we highlight this to the relevant developer and seek further information from them around this.
If the relevant developer doesn’t engage with us or is unable to provide any satisfactory additional information, such as evidence from a notified body that an app has been assessed as not being a medical device, we inform the developer that we will notify the MHRA of our concerns.
In the forthcoming new version of our review which takes account of the new Medical Device Regulations, these issues are also flagged prominently on the body of the ORCHA review and the ORCHA score is heavily reduced to reflect this compliance risk.
It should be noted however that with the introduction of the new Medical Device Regulations, many more health apps are being captured and classified as medical devices.
The health app market is struggling to catch up with these changes and the significant capacity issues in the notified bodies who support this space means that there is likely to be considerable none compliance issues arising which will capture both the good and the bad alike. A balance needs to be struck between flagging and suitably penalising none compliance with the wider impact on the public perception of this nascent but hugely valuable emerging therapeutic sector.