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Breaking: MHRA Changes Rules for Baby Movement & Breathing Monitors


 

MHRA CHANGES REQUIREMENTS FOR BABY MOVEMENT & BREATHING MONITORS
Snuza HeroMD Already a Medically Certified Device

[March, 2021: London, UK] — Until recently, many reports were claiming that baby movement and breathing monitors are not helpful, nor could they be trusted, partly because they are often not vetted through a Medical Device certification process and cannot clinically prove their promised value. A recent breakthrough ruling by the MHRA (Medicines and Healthcare products Regulatory Agency) in the UK now changes things, giving these devices a chance to earn the badge of trust they deserve. 

 

About the MHRA ruling

In March 2021, the MHRA embarked on a clampdown requiring all baby breathing movement monitor manufacturers to comply with the longstanding Medical Device Regulations to ensure their products are safe and effective for use. Now, all of these devices must apply for Medical Device Certification and become compliant in order to be allowed on the UK market. 

Snuza HeroMD Certified Medical Device

The good news here at Snuza is that our Snuza HeroMD is already a certified medical device— one of the few commercially available on the market. We went through the rigorous Medical Device certification process in 2016 and are proud to say that our device has maintained its medical device certification for the past 5 years.

The Snuza HeroMD is:

  • A certified Class IIb Medical Device - European Medical Device Directive MDD 92/43/EEC
  • The world's first portable monitor that has gone through an approved clinical evaluation process to prove it’s safe and effective in detecting infant apnoea
  • Endorsed by the Lullaby Trust in the UK

 

How do you know if your baby breathing/movement monitor complies?

Consumers are encouraged to check for a “relevant medical device conformity mark, either a CE mark or a UKCA mark, or a combination of those markings”, with the manufacturer’s Notified Body number alongside it.

This decision does not apply to stand-alone audio/visual monitors, which simply provide parents and caregivers with a live audio or audiovisual feed of their baby. However, audio/visual monitors with a built-in breathing/movement monitor will require certification

Click through for more information on the latest MHRA ruling.

ABOUT SNUZA

Snuza has been developing baby movement monitors, using leading edge bio-sensory technology, since 2007. Our monitors are aimed at monitoring a baby’s breathing movement and alerting parents of any incidents where the breathing movement has stopped. Snuza is a young, innovative and dynamic company, and the first baby tech company to have successfully introduced a portable baby movement monitor and also the world’s first portable baby breathing monitor. The Snuza team consists of motivated and dedicated individuals driving the development and distribution of baby monitors that speak for babies who are unable to at their most vulnerable moment — when they're alone in their crib and unable to breathe.



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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