Different types of Thermometers, Classification and Conformity assessment and routes for MDR CE Marking

 

Sl. No.ProductIdentificationMDR Classification

and Rule

Conformity Assessment Route
1.Clinical Electronic ThermometerA clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with electronic signal amplification, conditioning, and display unit.

 

The transducer may be in a detachable probe with or without a disposable cover.

Class IIa,

Rule 10

 

Technical Documentation

Annexes II & III

(Review as per Annex

IX Chapter II Section 4)

+

Annex IX Chapter I, III

(QMS)

 

OR

 

Technical documentation Annexes II and III

(Review as per Annex  IX Chapter II Section 4)

+

Section 10 (Production Quality Assurance) of Annex XI

 

OR

 

Section 18 (Product Verification) of Annex XI

 

2.Clinical color change thermometerA liquid crystal forehead temperature strip is a device applied to the forehead that is used to indicate the presence or absence of fever or to monitor body temperature changes.

 

The device displays the color changes of heat-sensitive liquid crystals corresponding to the variation in the surface temperature of the skin. The liquid crystals, which are cholesteric esters, are sealed in plastic.

Class Im,

 

Rule 1

Technical Documentation

Annexes II & III

+

Chapters I and III of Annex IX

(NB assessment is limited to the aspects relating to the conformity of the devices with the metrological requirements)

 

OR

 

Technical Documentation

Annexes II & III

+

Part A of Annex XI

(NB assessment is limited to the aspects relating to the conformity of the devices with the metrological requirements)

 

3.Liquid Crystal Forehead Temperature Strip
4.Clinical Mercury Thermometer Mercury-in-glass thermometers are no longer used in the European Union
5.Digital ThermometerThe Digital Thermometer is a general-purpose thermometer. The thermometer is intended for oral or axillary temperature measurements of the human body. The thermometer should be used with a smart phone or other Bluetooth smart device on which an app is installed. The thermometer communicates with the user’s device through a Bluetooth connection

 

Class IIa,

 

Rule 10

Technical Documentation

Annexes II & III

(Review as per Annex

IX Chapter II Section 4)

+

Annex IX Chapter I, III

(QMS)

 

OR

 

Technical documentation Annexes II and III

(Review as per Annex

IX Chapter II Section 4)

 

+

Section 10 (Production

Quality Assurance) of Annex XI

 

OR

 

Section 18 (Product Verification) of Annex XI

6.Non-contact Infrared Thermometers (NCIT)Infrared Thermometer is intended to detect body temperature from forehead in the population including infant (above 6 months), child, adolescent, and adult.

This noncontact infrared (IR) thermometer is mainly intended for industrial and office health screenings and monitoring.

It is only used as a reference for fever screening and cannot be used for medical identification.

Use of this thermometer is not intended as a substitute for consultation with a healthcare profession.

 

Class IIa,

 

Rule 10

7.Thermometer KitThermometer kits can contain a digital thermometer, infrared thermometer or thermocouple thermometer.

Simple kits come with a probe and holster, more complex kits air, surface and general-purpose probes as well as clamp probes and probe handles. Many come in soft, compartmentalized cases to keep elements organized and protected and some include record books for keeping track of data.

Class IIa,

 

Rule 10

8.Thermometer, Exhaled breathIt is mainly used to measure the temperature of exhaled human breath, which is frequently increased in airway inflammation in asthma patients.

Measurement of changes in exhaled human breath temperature aids in evaluating airway inflammation treatment in asthma patients as an adjunct to establish clinical and laboratory assessments of asthma.

 

Class IIb,

 

Rule 10

Technical Documentation

Annexes II & III

(Review as per Annex

IX Chapter II Section 4)

+

Annex IX Chapter I, III

(QMS)

 

OR

 

Technical Documentation

Annexes II & III

(Review as per Annex

IX Chapter II Section 4)

+

Type examination as specified in Annex X

+

Product conformity verification as specified in Annex XI

 

9.Fever Monitoring KitA clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.Class IIa,

 

Rule 10

 

Technical Documentation

Annexes II & III

(Review as per Annex

IX Chapter II Section 4)

+

Annex IX Chapter I, III

(QMS)

 

OR

 

Technical documentation Annexes II and III

(Review as per Annex

IX Chapter II Section 4)

+

Section 10 (Production

Quality Assurance) of Annex XI

 

OR

 

Section 18 (Product Verification) of Annex XI

10.Ear ThermometerThis digital thermometer allows to measure temperature through ear.