Dear Colleague 

We want to let you the outcome of a detailed review of baby breathing/movement monitors currently on the UK Market undertaken by the Medicines and Healthcare products Agency (MHRA) in 2020. 

Please note this does not affect conventional audio-visual baby monitors which are regulated as general consumer goods.              

The MHRA is aware that there are a wide range of baby breathing/movement monitors available for sale on the UK market. These products monitor the breathing, heart rate, movement and/or blood oxygen saturation levels of a baby, in various ways. Some products are specifically targeted at premature babies and many imply they can be of use in preventing Sudden Infant Death Syndrome (SIDS) and apnoea, both of which are clinical conditions.  

Many of these products are marketed as general consumer goods. 

The result of the MHRA’s detailed review determined that the majority of baby breathing / movement monitors currently on the UK market meet the legal definition of a medical device and they should therefore comply with the UK Medical Device Regulations 2002 (as amended). 

Going forward, the  MHRA will be working with impacted manufacturers to bring their products into compliance with the Medical Device Regulations 2002 (as amended).  

For consumers wishing to purchase a baby breathing / movement monitor,  they should look for one or more CE / UKCA /CE UK(NI) marks before buying. 

Purchasers should be aware that a disclaimer that a product is not a medical device or is not intended to diagnose or treat any specific medical condition does not automatically mean that a product would not be considered a medical device. 

For more information about baby breathing/movement monitors and buying medical devices for personal use, visit our webpage here.

Please share this information with your networks and contacts. 

Thank you

Kind regards

Patient, Public and Stakeholder Engagement