Guidance

Guidance on equipment for temperature screening in the context of the COVID-19 pandemic

Published 30 July 2021

1. Definition of “temperature screening equipment”

The MHRA is aware that many companies in the UK are now promoting and supplying equipment for non-contact “temperature screening” such as thermal cameras and infrared thermometers. These products are being promoted and used for the detection of raised body temperature (fever) in people as a supposed way of identifying people who may be infected with COVID-19. People who appear to have a raised temperature may then be refused entry to a building or event with the aim of reducing the risk of infecting others.

Some products already on the UK market with “fever detection” claims have been produced specifically for the purpose of measuring body temperature in human beings in a medical context, and as such are considered to be medical devices; others are non-medical products which have been repurposed with new, medical claims.

2. Classification of temperature screening equipment

The definition of a medical device is explained in Regulation 2(1) of the UK Medical Device Regulations 2002 (S.I. 2002/618, as amended). In summary, medical devices are products with an intended medical purpose which is achieved through physical or mechanical means and not by pharmacological, immunological or metabolic means.

The MHRA’s view is that products intended by their manufacturer to be used for measuring body temperature in human beings, with the aim of identifying people with a raised temperature in a medical context, meet the definition of a medical device. Products with claims indicating they are intended to be used for this purpose would be regulated by the MHRA.

Some products on the market are specifically intended and designed by their manufacturer to be used for measuring human body temperature. They have specifications which enable them to measure body temperature with a defined level of accuracy. These products should already be compliant with the requirements of medical device legislation and therefore should be CE, CE UKNI UKCA marked. See our guidance on the UKCA mark for more information.

Some temperature measuring products were intended and designed for only non-medical purposes by their manufacturer, for example:

• thermal cameras for:

  • premises security

  • Fire and Rescue services

  • military use

• infrared thermometers and thermal cameras designed to measure temperatures during industrial manufacturing processes.

These non-medical products are unlikely to have specifications which would allow accurate temperature measurement in people and are unlikely to meet the requirements of the medical device regulations.

3. Temperature screening in the context of COVID-19

Fever is one possible symptom displayed when a person is infected with the virus which causes COVID-19, and businesses and the public may find temperature screening procedures reassuring. Some medical devices allow temperature to be checked without close physical contact with another person. Using these devices, a large number of people can typically be checked in a short space of time and in a non-disruptive way.

However, temperature screening, when used as a single or main diagnostic test for COVID-19, has several limitations.

Not all equipment promoted for temperature screening is the same. Using a product which does not measure temperature accurately will mean results are unreliable.

Temperature screening, even with highly accurate equipment, cannot detect people who are infected with COVID-19 if they:

• are asymptomatic (people who do not feel or look ill, and may not realise they are infected at all)

• are at an early stage of infection and have not yet begun to display any signs or symptoms

• display other symptoms such as a cough, but never develop a fever

• develop a fever during the course of their infection, but do not have a raised temperature at the moment their temperature is checked

4. If you are buying & using these products

The MHRA warned against overreliance on temperature screening equipment to diagnose COVID-19 in our press release on this subject, especially if overconfidence in the result may lead to behaviours which will increase the risk of spreading COVID-19.

The MHRA are not currently considering any sort of restriction on the use by businesses of any temperature screening equipment in the context of the COVID-19 pandemic. However, if businesses and organisations wish to use non-medical products for temperature screening at their own premises, outside the manufacturer’s original intended purpose for the products, they would be doing so at their own risk. They should therefore be fully aware of the potential consequences in doing so, which include creating a false sense of security in relation to COVID-19 transmission.

If you are using temperature screening equipment at your business:

• temperature screening should not replace any other COVID-19 preventative measures – follow the government advice on safe working during COVID-19 at all times, even when all temperature readings appear normal

• read the manufacturer’s instructions for using the device and follow these instructions every time the device is used

• ensure you and delegated staff know how to use the device effectively

• make sure you have a process in place for what to do when a person is found to have a raised temperature

• consider using additional suitable methods for screening and for testing for COVID-19, for example, a different method of testing using a CE, CE UKNI or UKCA marked diagnostic medical device

Please note that the MHRA does not directly license or approve medical devices. There are, therefore, no “MHRA approved” temperature screening products.

If you are intending to buy temperature screening equipment:

• check the device specifications for the level of accuracy claimed. This should be plus or minus 0.5°C (or better) for thermal cameras or plus or minus 0.3°C (or better) for thermometers. A smaller number represents higher accuracy.

• check whether the product has been CE, CE UKNI or UKCA marked, and which legislation the manufacturer says it complies with:

• many types of product are required to be CE marked to show they are compliant with certain EU legislation. Medical devices and most electronic products should carry a CE mark. From 1 January 2021, such products for the Great Britain market may carry a UKCA mark to show compliance with UK legislation.

• CE marking / UKCA marking is required under various different regulations. Check whether the CE-marked product claims compliance with Directive 93/42/EEC or Regulation (EU) 2017/745; or that a UKCA-marked product claims compliance with the UK Medical Devices Regulations 2002. This means the manufacturer has created the equipment as a medical device and it is intended to be used for a medical purpose. Electronic temperature screening equipment, if compliant with medical device legislation, should also carry a 4-digit Notified or Approved Body number next to the CE, CE UKNI or UKCA mark.

Please also see our information for users and patients and guidance on buying products online.

5. If you are manufacturing or supplying these products

Direct claims by the manufacturer suggesting that the product is intended to be used for screening human beings for fever, COVID-19 or other illness would bring the product within the definition of a medical device.

Products with relevant claims can be regulated as medical devices even where the supplier includes disclaimers indicating that the product is not a medical device cannot diagnose COVID-19, or that it is only for preliminary screening in combination with other testing methods.

Thermal cameras and digital thermometers intended for medical purposes would usually be considered “active” medical devices, although other types of temperature measuring/monitoring devices may have different classifications. The MHRA considers active medical devices intended for human body temperature measurement or monitoring to be Class IIa medical devices.

The manufacturer of a medical device must demonstrate that their device complies with the applicable essential requirements (see Part II of the Medical Devices Regulations 2002, Annex I [as modified by Part II of Schedule 2A to the Medical Devices Regulations 2002]), and follows an appropriate route to demonstrate conformity. For a Class IIa device, manufacturers must engage a duly designated EU Notified Body to carry out a conformity assessment and issue CE certification before the device may be CE marked and placed on the market. CE marking will be accepted in Great Britain until 30 June 2023.

From 1 January 2021, manufacturers of medical devices to be placed on the market in Great Britain (England, Wales and Scotland) may also apply to duly designated UK Approved Bodies for UKCA certification and affix a UKCA mark to their medical devices.

Note that the rules for placing medical devices on the Northern Ireland market differ from those applicable to Great Britain. CE marking is required to place devices on the Northern Ireland market. If conformity assessment and certification is undertaken by a UK Notified Body, the CE mark must be accompanied by the UKNI mark.

Please see our guidance on the legal requirements for medical devices in the UK for more information.

Relevant standards for temperature screening medical devices include:

• thermal cameras: BS EN IEC 80601-2-59:2019 Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

• thermometers: BS EN ISO 80601-2-56:2017 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

These standards require an accuracy of:

• plus or minus 0.5°C (or better) over the range of at least 34 - 39 °C for thermal cameras

• plus or minus 0.3°C (or better) over the range of at least 34 - 42 °C for thermometers

Technical documentation for any medical device must include scientific and clinical data to demonstrate the safety and effectiveness of the device, and manufacturers must hold the data required to substantiate any claims they make about their device.

Non-medical temperature measurement equipment which cannot meet the appropriate level of accuracy for human temperature measurement should not be sold with claims suggesting it is suitable for fever detection in people.

6. Report a problem with temperature screening equipment

Please report adverse incidents involving temperature screening equipment through Yellow Card and also report any suspicion of fraud or counterfeiting to us by emailing Devices.Compliance@mhra.gov.uk.

7. Further information

MHRA press release on temperature screening products

For enquiries on the regulation of temperature screening equipment, please contact devices.regulatory@mhra.gov.uk .