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What is the risk class of my medical device?

08.05.2021

In accordance with the Medical Device Regulation 2017/745 (MDR) all medical devices must bear a CE marking. By affixing a CE marking to a medical device, the manufacturer or importer confirms the conformity of the medical device with the essential requirements of the abovementioned Regulation. Medical devices bearing a CE marking are allowed to be placed freely on the market within the European Economic Area (EEA).

Medical devices are divided into four categories or classes, from the lowest to the highest risk class: I*, IIa, IIb and III. The higher the risk for the patient/end-user, the higher the risk category. This also includes that the higher the risk category of a device, the more attention and time will be paid to this device by market surveillance authorities.

Class IClass IIa and IIbClass III

Medical devices without a measuring function and/or sterility requirements (low risk class)

Class I devices include, e.g., stethoscopes, hoists, bandage and band aids. These devices pose a relatively low risk to the patient, unless it concerns a sterile class I device or a device with a measuring function.

* Class I devices are further subdivided as follows: sterile devices (ls), devices with a measuring function (lm) or reusable surgical instruments (lr). These devices are classified between the low and medium risk class.

Medium risk

Examples of class IIa devices are injection needles, hearing aids, or contact lenses. Examples of class IIb devices are anaesthetic equipment or a blood transfusion bag.

High risk

Medical devices in class III are devices that are in direct contact with the body and the central nervous system, the heart and the central circulatory system. Since these are medical devices that control, diagnose, monitor or correct a specific problem of the heart or the central circulatory system, these devices are classified as risk class III devices. Furthermore, these devices belong to the highest risk category, because they are in direct contact with the abovementioned parts of the body.

Examples of class III devices are heart cathethers and spirals, as well as breast implants and active implantable medical devices and the accompanying accessories of these implantable devices.

Changes as of May 2021

As of 26 May 2021 the Directive 93/42/EU will be repealed and replaced by the Regulation 2017/745. Within the scope of the MDR, there are 22 classification rules (Annex VIII).
By implementing the Regulation the classification rules have changed:

  • Surgical gauzes will fall within class III;
  • New rule 11: classification of software. Software may fall within every risk category;
  • Rule 18: non-viable tissues or cells from human or animal origin will fall within class III;
  • Rule 19: classification of nanomaterial depends on the potential for internal exposure;
  • Rule 20: devices intended for inhalation of medicinal products will fall within class IIa or IIb;
  • Rule 22: active therapeutic devices with an integrated diagnostic function that generates patient management data, will fall within class III (e.g., devices with a closed loop system or automated external defibrillators).

How can we assist you with the classification of your medical devices?

Would you like to receive more information or would you prefer to have your medical device qualified, classified and certified by a specialist? Please contact Certification Company:
By phone: +31 (0)36 202 40 12
By e-mail of by using our contact form.

 

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