The International Medical Device Regulators Forum (IMDRF) has published a document on the classification of in vitro diagnostic (IVD) medical devices. It has been created with the aim of harmonising the classification of IVD devices in order to ensure a globally consistent approach to premarket approval.
The general principles used to help define the classes are understanding:
- The intended use and indications for use as specified by the manufacturer
- The technical/scientific/medical expertise of the intended user (lay person or healthcare professional)
- The importance of the information to the diagnosis (sole determinant or one of several), taking into consideration the natural history of the disease or disorder including presenting signs and symptoms which may guide a physician
- The impact of the result (true or false) to the individual and/or to public health.
From this, a four-class alphabetical system has been proposed by the IMDRF for device classification:
- Class A – low individual risk and low public health risk
- Class B – moderate individual risk and/or low public health risk
- Class C – high individual risk and/or moderate public health risk
- Class D – high individual risk and high public health risk
More complex and risky devices are subject to more stringent regulatory requirements and the device classes have been created to mirror this relationship.
Further guidance within the document clarifies certain scenarios to manufacturers attempting to determine what class their device falls into:
- Where an IVD device has multiple intended uses that cause it to be listed under more than one class, it will be classified in to the highest class possible.
- Where more than one classification rule applies to an IVD device, it should be listed in the highest class indicated by any of the rules it falls under.
Classification rules are a set of seven rules set out by the IMDRF which further help manufacturers determine which class their device should be categorised as. The rationale for each rule is explained and examples are provided to assist manufacturers in understanding which rules may apply to their device(s).
To view the document in full, click here.