Why your Baby Monitor should be medically certified
What is medical certification? And what monitors does this legislation affect?
Reassurance that your newborn is safely sleeping is important for all parents, and that is why the MHRA has undertaken “a detailed review and determined that the majority of baby breathing/movement monitors are medical devices. Consequently, we will be working with the relevant manufacturers to bring their products into compliance with the Medical Device Regulations 2002 (as amended)”
Baby breathing/movement monitors purchased to use at home typically provide information to the parent or caregiver about a baby’s health and wellbeing. They alert the parent or caregiver if the baby’s vital signs give cause for concern or even intervene automatically to restart the baby’s breathing.
Examples of vital signs include heartbeat, breathing, blood oxygen saturation levels and body temperature. 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.
Because these products typically offer to identify, monitor, or, in some cases treat a medical condition, the MHRA’s view is that these products meet the legal definition of a medical device and that they should therefore comply with the UK Medical Device Regulations 2002 (as amended).
This means that the device needs to 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.
Note that this decision does not apply to conventional audio-visual baby monitors which only enable a parent to ‘listen to and/or view’ the baby to determine if the baby is awake or asleep.
What should you be looking for when purchasing a baby monitor that monitors more than just video & sound?
Consumers wishing to buy a baby breathing/movement monitor should look for one or more of these conformity marks before buying: CE / UKCA /CE UK(NI).
You should be aware that a disclaimer statement from the manufacturer saying 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.
Top Tips
· check it has CE marking, UKCA marking or CE UKNI marking
· check if the manufacturer’s address is on the device or the packaging
Before you start using the device, it’s important to:
· check the device is not damaged.
· make sure you understand and follow the instructions.
· make sure you keep your proof of purchase from your relevant retailer.
· make sure you have everything you need, for example, find out if the device needs anything else to make it work such as test strips, batteries etc.
· keep the device in good condition by following instructions about service and maintenance.
· store the device according to the manufacturer’s instructions - for some devices the wrong temperature or humidity can affect how it works or give you wrong results.
Introducing the Angelcare AC25-1 Baby Movement Video and Sound Baby Monitor.
Rest assured knowing your baby is sleeping soundly with a hospital-tested and clinically validated baby monitor.
How it works…
Simple and easy to use, the Angelcare AC25-1 Baby Movement Monitor with Video & Sound makes bedtime a breeze. Simply place the non-contact wireless sensor pad (with 4 sensitivity levels) under the mattress and as your baby sleeps, the advanced Sensor Pad technology keeps an eye on every movement across the entire cot. Plus, with the 4.3” screen with infrared night vision, you can keep a close eye when you are in another room.
Fantastic features!
With its unique design, this innovative monitor will play soothing lullabies and provide a gentle nightlight to create the perfect environment for your baby’s sweet dreams. Keep an eye on the room and temperature with the handy display on the Parent Unit. Plus, if your little one is having a bad dream and needs some reassurance, the handy two-way audio can be used to comfort your little one from afar.
Learn more: Angelcare® AC25-1 Baby Movement Monitor with Video & Sound