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

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a formal notification regarding the regulatory requirements for temperature screening equipment, such as thermal cameras. Under the Medical Devices Regulations 2002, any device marketed for medical purposes, including fever detection for disease screening, must meet stringent safety and performance standards. While the provided text serves as a contact directive for regulatory inquiries, the overarching MHRA guidance addresses significant industry violations, primarily the marketing of screening products with misleading diagnostic claims. The agency highlights that these devices are often not calibrated for clinical use and lack the necessary evidence to support their efficacy in identifying specific infections. Although the snippet does not specify a particular company or inspection dates, the MHRA framework requires manufacturers to obtain valid CE or UKCA marking before placing such devices on the market. Required actions for stakeholders include ensuring all promotional materials accurately reflect the device's capabilities and verifying that hardware meets legal definitions of a medical device. Organizations seeking further clarification or needing to report compliance issues are directed to contact the MHRA at info@mhra.gov.uk to ensure public health is not compromised by inaccurate screening tools.