Thermoscanner, the CE marking as guarantee of safety and quality

3 July 2020

Thermoscanners are an essential tool for companies to control and monitor the risk of a new spread of the virus Covid-19.
In recent months, Ente Certificazione Macchine has been increasingly involved in activities on these devices, to verify their compliance as madical devices with Directive 93/42/EEC and carrying out the necessary tests to assess their safety and performances.

On the market it is possible to find many models and types, produced in Europe or coming from extra-European countries. Considering the large request of these devices due to the emergency related to the coronavirus outbreak, it is necessary to pay attention and make sure, before buying or using any products, that all the necessary activities for the CE marking have been carried out, in compliance with all applicable directives. The CE mark must be affixed on the products or on the box, together with the number of the Notified Body that issued the certification.

Thermoscanners are electromedical devices, classified as Class IIa medical devices, and to be sold within the EU market they must comply with the requirements of Directive 93/42/EEC (MDD) or the new Medical Devices Regulation 2017/745 (MDR). This assessment is carried out by a Notified Body authorised, once the conformity of the device has been verified, to issue the CE certification.

Any devices different from those described above, common infrared thermometers or other thermoscanners (not classified as medical devices) cannot be considered reliable instruments for the measurement of body temperature as they have not been tested and certified according to the safety and quality standards required by European directives and regulations.

In the workplace and, in general, wherever it is necessary to carry out systematic body temperature screening for the protection of people’s health, it is essential to get equipped with devices that ensure a safe use and reliable results. Thermoscanners CE marked as medical devices provide the guarantee that they have been assessed and tested according to the strictest European standards, for the protection of market and users. In the case of controls or complaints, the employer can demonstrate that he has used the appropriate instrument that unequivocally ensures that the necessary steps to ensure the safety of his workers have been taken.

Ente Certificazione Macchine – European Notified Body for Directive 93/42/EEC and ISO 17025 Accredited Testing Laboratory – provides a professional and efficient CE certification service for medical devices, including thermoscanners, and carries out the necessary testing activities to measure the performances and assess the safety requirements of devices, in terms of electrical safety and electromagnetic compatibility.
For more information, please contact us at:
Paolo Bernardoni – ECM Sales Manager | +39 345 9938661
Antonio Balassone – Sales Manager Medical Devices | +39 393 2471040