Does this product meet regulatory standards

The Medicines and Healthcare product Regulatory Agency (MHRA) has overall responsibility for ensuring that regulatory standards for medical devices are met. A manufacturer must ensure that any medical device placed on the market or put into service has the necessary CE marking. CE marking should be viewed as a minimum threshold for certifying that the device is safe, performs as intended and that the benefits outweigh the risks. From 1 January 2021, because of the UK leaving the EU, there will be several changes to how medical devices are placed on the market. These changes include introducing the UKCA UK Conformity Assessed as a new route to product marking.

Intended use and risk classification

You should be clear about the intended use of the product:

• what exactly it can be used for
• under what specific conditions it can be used

This should enable you, in turn, to be clear about the product’s risk classification. Medical devices can be classed as I, IIa, IIb or III in order of increasing risk. The requirements for obtaining a CE mark are similar across all the classes but the complexity and amount of effort increases as the risk class increases.

Products that are not medical devices

Where an AI product is not categorised as a medical device and is designed, for example, to improve efficiency rather than support specific clinical or care-related decision-making, regulations require manufacturers to develop their technology in line with ISO 82304 for healthcare software.