The International Medical Device Regulators Forum (IMDRF), an association composed of medical device regulating authorities, proposed new principles of classification of the in vitro diagnostic medical devices. The organization itself is focused on the development and improvement of the existing regulatory frameworks to ensure the highest level of public health protection. To achieve this goal, the IMDRF develops guidance documents that could be implemented by the national regulating authorities of the Member States. 








General Approach to IVDs


The document recently issued by the IMDRF is intended to assist medical device manufacturers in the determination of the proper class of the IVD device in accordance with the risk-based classification. It is also important to mention that the appropriate national medical device regulating authority would be entitled to perform the final determination of the device. The association also emphasizes the importance of harmonization of regulatory approaches used in the Member States to simplify the procedures to be taken when placing the device on the foreign market. For this purpose, the IMDRF recommends a national medical device regulating authorities utilizing another classification approach to implement the main classification principles described in the present document. 

The IMDRF indicates that the guidance is intended to:

  • Provide medical device manufacturers with the additional information necessary to perform correct determination of the device class under the risk-based classification,
  • Describe core principles of classification based on the intended purpose of the device,
  • Provide national regulating authorities with the additional information necessary for the correct interpretation of existing principles. 

The scope of the document covers all medical devices falling within the definition of the in vitro diagnostic medical device. 

The document also provides definitions of the most important terms related to the sphere of the guidance including, inter alia, the following ones:

  • Accessory for an IVD medical device – the item that is not an IVD device itself but is initially intended to be used with medical devices. 
  • Companion diagnostics medical device – an IVD device necessary to ensure the safety and effectiveness for the intended purpose of the appropriate medicine and used to identify patients that would potentially benefit from the medicine or those who would be exposed to the increased risk associated with using the medicine. The IMDRF also states that comparison diagnostics are necessary to determine the eligibility of the patients in terms of specific treatment. At the same, the definition of companion diagnostics does not include the devices intended to monitor the concentration of medicines. 
  • Self-testing IVD medical device – a device intended by the manufacturer to be used by the users themselves and on themselves in accordance with the instructions for use accompanying the device. 
  • Software as a Medical Device (SaMD) – software with the intended medical purpose, that is not a part of a hardware medical device. 

According to the definition provided in the document, in vitro diagnostic medical devices include “reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus…”. It is stated that IVD medical devices could be used for diagnosing, monitoring and screening, and other test purposes. 



IVD Medical Devices: Main Principles


According to the document, the risk associated with the use of the device mostly depends on:

  • The intended purpose of the device as indicated by the manufacturer, and
  • The intended user.

Thus, the requirements applicable to the particular device should depend on the risk associated with the use of the device. The IMDRF emphasizes the importance of establishing an appropriate balance between ensuring a high level of patients` health protection and avoiding the unnecessary regulatory burden preventing the manufacturers from placing their devices on the market. 

In accordance with the document, classification of in vitro diagnostic medical devices should depend on the following aspects:

  • The intended medical purpose of the device and indications for use,
  • The required qualification of the intended user (whether it should be a patient himself or healthcare professionals),
  • The way the information provided by the device should be used (its importance),
  • The potential impact of the outcome (result).

It is stated correct class of the device should be determined depending on its features causing a certain risk to the user (patient). The proposed system should include four risk classes. 

The IMDRF additionally provides a list of the most important aspects to be taken into consideration, namely: 

  • Regulatory clarity of the rules and requirements allowing the manufacturers to apply them easily in a correct way, while the national regulating authority should be able to make a final decision regarding the correct risk class determination in case of any doubts or borderline situations.
  • All justifications of the particular determination of the device class should be duly documented by the manufacturer, and the appropriate documentation should be provided to the national regulating authority or conformity assessment body upon demand. 
  • The requirements should be based on the state of the art. 
  • In case if due to the features of the particular device more than one rule could be applied, the final determination should be based on the highest class applicable. 
  • Calibrators should be assigned to the same risk class as the in vitro diagnostic reagents they are intended to be used with. 
  • Classification of the Software as a Medical Device should be based on the intended purpose. 


Recommendations on Classification


The IMDRF proposes to utilize an alphabetical system consisting of four classes. When determining the particular class, the manufacturer shall take into consideration both a public health risk and individual health risk. 

It is important to mention that the level of regulatory requirements increases together with the class of the device. According to the example the document contains, the following requirements could be applied depending on the risk class of the device:

  1. Establishing a proper quality management system,
  2. Providing the appropriate clinical evidence in accordance with the intended purpose of the device indicated by the manufacturer,
  3. Providing technical files,
  4. Evaluation and testing of the device,
  5. Mandatory external audit of the quality management system utilized by the manufacturer,
  6. Reviewing the technical files by the independent third-party auditor. 

In order to determine the correct class under the risk-based classification the device should be assigned to due to the risk associated with the use of the device, the manufacturer shall perform the following steps:

  1. To determine whether the device in question is an in vitro diagnostic medical device, 
  2. To evaluate all intended purposes of the device and to make the determination based on the highest class applicable,
  3. Assess the applicability of the device-specific national rules and requirements. 

In case if the application of national rules and requirements results in applying the conformity assessment procedures that differ significantly from the generally accepted, this could impact the eligibility of the device for the free distribution and placing it on the foreign markets. 

Summarizing the information provided hereabove, the document issued by the IMDRF covers the most important aspects to be taken into consideration by the medical device manufacturer when considering the proper class of the IVD medical device. 





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