Risk classification

It is the classification rules in the regulations that determine the class that the device belongs to.

The classification rules can be found in Annex VIII in both MDR and IVDR.

The following applies to the classification of devices:

• The manufacturer’s intended purpose for the device determines its classification.
• The manufacturer must refer to all classification and implementation rules in order to determine the correct classification of the device.
• If the device in question is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices.
• Software which drives a device or influences the use of a device, shall fall within the same class as the device.
• If the software is independent of any other device, it shall be classified in its own right.
• If the device is not intended to be used solely or principally in a specific part of the body, it shall be considered and classified on the basis of the most critical specified use.
• If several rules, or if, within the same rule, several sub‍-‍rules apply to the same device based on the device's intended purpose, the strictest rule and sub‍-‍rule resulting in the higher classification shall apply.
• A device is considered to allow direct diagnosis when it provides a diagnosis of a disease or condition in question by itself or when it provides decisive information for the diagnosis.

The categorisation determines, inter alia, what procedures must be implemented in order to demonstrate that the devices comply with the requirements of the regulatory framework. The higher the risk class, the greater the involvement of a notified body in the conformity assessment.

General safety and performance requirements as well as requirements regarding technical documentation apply to all devices, regardless of their class. Additional relevant requirements for conformity assessment depend on the class of the device. For some classes, the manufacturer may choose the procedure.

Conformity assessment based on risk class

Devices covered by the EU Regulation must belong to one of the risk classes. The classification into risk classes ranges from devices in class I with the lowest risk potential to devices in class III with the highest risk potential.

The extent to which the notified body must review the conformity depends not only on the device’s risk class, but also other factors such as whether the device is delivered in a sterile state.

Class I

Manufacturer of class I devices confirm by the declaration of conformity, that the device complies with the requirements of the regulatory framework. However, the involvement of a notified body is required for devices that; have a measuring function (class Im), are placed on the market as sterile devices (class Is) or are reusable surgical instruments (class Ir).

Class IIa

Class IIa are devices with low to moderate risk where review by a notified body is required for certain parts. In order to be able to CE mark a product, the manufacturer can choose between two options:

• Conformity assessment based on the device’s conformity, including an assessment of at least one representative device for each category of device.
• Conformity assessment based on a quality management system and an assessment of the technical documentation and an assessment of the technical documentation of at least one representative device for each category of devices.

Class IIb

Devices in class llb have a high risk potential and shallbe reviewed by a notified body. In order to be able to CE mark a device, the manufacturer can choose between two options:

• The notified body carries out a type‍-‍examinationof the device combined with production quality assurance. For implantable devices in class llb, an assessment of technical documentation shall be applied to each device.
• Conformity assessment based on a quality management system and an assessment of the technical documentation and an assessment of the technical documentation of at least one representative device for each category of devices.

Class III

Devices in class llb have a high risk potential and must be reviewed by a notified body. In order to CE mark a device, the manufacturer can choose between two options:

• Conformity assessment based on a quality management system and an assessment of the technical documentation.
• The notified body carries out a type‍-‍examination of the device combined with production quality assurance.

Specific assessment:

• Measuring function: Assessment of the aspects relating to the conformity of the devices with the metrological requirements.
• Sterile: Assessment of the aspects relating to the establishment, securing and maintenance of sterile conditions.
• Reusable surgical instruments: Assessment of aspects relating to reuse of the device, in particular cleaning, disinfection, sterilisation, maintenance and functional testing and the related instructions for use.
• For certain devices in classes III and llb, the notified body will consult an expert panel regarding the clinical evaluation before the devices are CE marked and placed on the market.

In vitro diagnostic medical devices — conformity assessment based on risk class

The EU Regulation stipulates that each device must belong to one of the risk classes A‍-‍D, where devices in class A have the lowest risk potential and devices in class D have the highest risk potential, and determines which risk class the device belongs to. Involvement of a notified body is required for all devices in classes B‍-‍D, and also for some devices in class A which are placed on the market in sterile condition.

For devices intended for self-testing or near‍-‍patient testing, the involvement of a notified body is required, regardless of risk class.

Class A

Manufacturers of products in class A certify through their declaration of conformity that the device complies with the requirements of the regulatory framework.

• If the devices are placed on the market in sterile condition, the notified body shall review aspects relating to establishing, securing and maintaining sterile conditions.

Class B

• Assessment is carried out based on a quality management system, including an assessment of the technical documentation of at least one representative device for each category of device.

Class C

In order to be able to CE mark a device, the manufacturer can choose between two options:

• Conformity assessment based on a type test combined with a conformity assessment based on the quality assurance of production.
• The assessment is carried out based on a quality management system and an assessment of the technical documentation of at least one representative device for each category of device.

Class D

In order to be able to CE mark a device, the manufacturer can choose between two options:

• Conformity assessment based on a type test combined with a conformity assessment based on the quality assurance of production.
• Conformity assessment based on a quality management system and an assessment of the technical documentation.

Specific assessment:

• Manufacturers of products intended for self-testing or near-patient testing must implement the procedure for the assessment of technical documentation.
• For companion diagnostics, the notified bodies must consult the competent authorities for medicinal products.
• Class D devices in production must be tested by an EU reference laboratory (if one has been designated for the type of device).

For innovative Class D devices, where no common specifications (CS) are available, the notified body shall consult an independent expert panel on the performance evaluation report of the manufacturer.