Infrared (IR) thermometers: caution in use
The MHRA has become increasingly aware of infrared thermometers being sold in the UK that do not comply with the regulations.
Documents
Details
These thermometers are making claims that they can be used for a medical purpose. This means that they should have been assessed to make sure they meet the essential requirements of the Medical Devices Regulations 2002 before being sold on the UK market.
This type of device has become increasingly available in the UK during the COVID-19 pandemic.
Before buying an infrared thermometer
You should look for the information listed below. It should be on the device and packaging. If it is not there or the seller can’t provide it, you should not buy the thermometer.
- Name and address of the manufacturer
- If the manufacturer is not in the EU or UK, the name and address of the European representative or UK Responsible Person
- The CE mark symbol with a 4-digit number. This number identifies the independent third-party organisation (notified body) which has assessed the device
- Model number and/or name of the device
- Lot or batch number
Examples of thermometers without the proper information on the packaging or device
The attachments above show the problems with the labelling:
- there is a CE mark but without a 4-digit number
- the CE mark is not in the correct format
- the package says ‘Made in China’ but there are no details of the manufacturer or EU Authorised Representative
The ‘CE’ mark on this device does not comply with the Medical Devices Regulations. Although it looks very much like the CE mark, there are very small differences that are very hard to spot. The two letters are too close together and, for this type of device, the 4-digit number is missing. The image below shows the correct positioning of the letters and formatting of the letter E for a CE mark compared with the invalid ‘CE’ mark.
Actions
If any of this information is missing, the thermometer may not meet the legal requirements and you should not buy or use it.
- Inform the company that provided you with the thermometer about the missing information.
- Report any problems with the thermometer to the MHRA or your national reporting authority. Healthcare professionals: report any suspected or actual adverse incidents involving these devices through your healthcare institution’s local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.
Members of the public can report through MHRA’s Yellow Card scheme.
Background
Since the start of the COVID-19 pandemic, contactless infrared thermometers are being used widely to check people’s temperature as a possible sign that they have the infection.
The MHRA issued guidance stating that they are not a reliable way to detect if people have the virus here.
There is detailed information on the CE and UKCA marking on this page.
For general advice and tips on purchasing medical products visit our web pages for buying medical devices and buying medical products online..