Implementation and interpretation of IVDR classification rules

Implementation of risk classification by the manufacturer

Under the IVDR the manufacturer is responsible for identifying the risk class applicable to its IVD device. The notified body will verify the correctness of this classification for Classes B, C and D devices. A competent authority may also verify the classification, including for Class A devices. It is therefore important for manufacturers to have an adequate rationale documented on file for its classification decisions.

The manufacturer should proceed as follows:

• Determine the intended purpose of the device
• Ensure that the performance of the device and related scientific validity can be demonstrated
• Review all the classification rules and determine which is the highest risk class applicable to the device. It is possible that several rules apply or that the device has multiple intended uses; in that case the rule resulting in the highest risk class must be applied.

Devices are generally classified in their own right. This applies to situation when two or more devices are used together, standalone software and accessories. However, there are exceptions to this basic principle:

• Software which drives or influences the use of a device falls in the same class as that device
• Calibrators intended to be used with a device fall in the same class as that device
• Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes shall be classified in the same class as the device.

Interpretation of classification rules

A new institutional structure has been created to support the implementation of the new regulations. The Medical Device Coordination Group (MDCG) plays a key role in this. Classification issues are among the tasks that the MDCG will have responsibility (Art. 99). Several working groups have been created under it, one of which will deal with issues of classification. Although the MDCG working groups are mainly composed of representatives of the Member States, access has also been provided for experts of stakeholders (industry trade associations, etc.).

Guidance was issued by the Commission on classification of medical devices under the old system. This is in process of being updated so it is likely that interpretation of the classification rules for IVD devices will emerge in due time from the MDCG.

The Commission may also adopt implementing acts to resolve issues of interpretation (Art. 47.5).

If the manufacturer and notified body disagree on the classification of an IVD device, the dispute can be referred to the competent authority of the Member State of the manufacturer or of the authorized representative. If the notified body is in a different Member State, the competent authority of that Member State will be consulted (Art. 47.2).

This is an excerpt from the BSI medical devices white paper: Explaining IVD classification issues. To browse our collection of medical device white papers, please visit the Insight page on the Compliance Navigator website.