(In the UK!!)
I often see comments online from laser suppliers and users discussing “medical grade” lasers but what exactly does that mean?
Well, the first thing that we should understand is that a medical grade laser is not a defined legal or regulatory designation in the UK. It is essentially a marketing term!
The legally meaningful concept is whether a particular laser or IPL is a medical device under the UK Medical Devices Regulations 2002 (UK MDR 2002). These regulations define a medical device by its intended purpose. In other words the device has to be used for what are deemed to be ‘medical’ purposes.
This is actually quite an important distinction because the MHRA explicitly says that not everything used in healthcare, or even used by a healthcare professional, is a medical device.
So that begs the question: what does “medical grade laser” actually mean?
There is no regulatory answer. A manufacturer, supplier or a clinic might be trying to convey that their device is a regulated medical device and is manufactured under the medical device quality system. But none of those things makes ‘medical grade’ itself a recognised classification.
In fact the MHRA makes this point themselves. In its biological safety guidance it calls out a widespread misconception that things such as ‘medical grade’ or ‘surgical grade’ have some universal regulatory meaning, stating that there is no UK regulation or standard which defines medical grade devices.
What about lasers used in aesthetics?
Well, at the moment, the UK government has specifically identified hair removal lasers, tattoo removal lasers, IPLs and similar high-intensity optical equipment as examples of products that can have aesthetic or non-medical intended purposes. Consequently they do not necessarily fall under the UK MDR 2002 regulations.
So what does this mean in reality? Well it leaves a bit of a grey area. We have the situation where a manufacturer or supplier could offer a class 4 laser for the purposes of treating medical conditions whereas another supplier could offer the same sort of laser but only for the removal of hair or tattoos.
The first laser would likely be deemed a medical device (correctly), whereas the second laser would not and calling it ‘medical grade’ makes no difference.
So, the next time you see a clinic or a salon advertising something like “we only use medical grade lasers,” just keep in mind that it doesn’t actually mean anything legally or under the current regulations – unless they are specifically using it for medical conditions, as defined by the government/MHRA.
As I’ve been saying for decades, watch out for the marketing baloney!!
Ciao for now,
Mike.
Mike Murphy's Blog 