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Breaking: MHRA Changes Rules for Baby Movement & Breathing Monitors


 

When it comes to baby movement and breathing monitors, there has been a tendency to dismiss them as nice to have, but not medically helpful. However, new laws in the UK seem to be accepting that advances in technology have rendered these monitors medically sound.

As of March 1 2021, the MHRA (Medicines and Healthcare products Regulatory Agency) have changed the definition of baby movement and breathing monitors from general consumer goods to medical devices. 

With these laws, devices that claim to “identify, monitor, or, in some cases treat a medical condition” should “have undergone a conformity assessment to demonstrate that it works as intended and is acceptably safe”. 

“Following a positive conformity assessment, the device would need to bear a relevant medical device conformity mark, either a CE mark or a UKCA mark, or a combination of those markings. If the device is being placed on the market in Northern Ireland, then it would also need to be appropriately marked with a UK(NI) indication.”

This is great news for us, as it supports our desire to get our products — especially the Snuza HeroMD — into the hands of the parents of newborns. By using a medically certified device, such as the Snuza HeroMD, parents can be reassured that their precious baby is being monitored by certified medical technology. 

The Snuza HeroMD is:

  • A certified medical device (CE 1639 - Medical Device Class: IIb (Rule 10) (Annex II) MDD 92/43/EEC)
  • The world's first portable monitor clinically proven to detect infant apnoea
  • Endorsed by the Lullaby Trust in the UK

Going forward, all baby movement and/or breathing monitors will have to pass these tests in order to be allowed on the UK market. Consumers should check for a “relevant medical device conformity mark, either a CE mark or a UKCA mark, or a combination of those markings”. 

This decision does not apply to audio/visual monitors, which simply provide parents and caregivers with a live audio or audiovisual feed of their baby, although these can be used in conjunction with the baby movement and breathing monitors to transmit alarm sounds if your baby does not share a room with you.

Click through for more information on these changes to the MHRA laws.



Sources:

  1. Medical devices: information for users and patients — Baby breathing/movement monitors: https://www.gov.uk/guidance/medical-devices-information-for-users-and-patients#baby-breathingmovement-monitors
  2. Snuza HeroMD: https://www.snuza.com/product/hero-md/ 

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