How does the IVDR impact risk classification?

The new IVDR establishes a set of risk-based classification rules

Since the European Union started to regulate medical devices in the 1990s, a key element of the regulatory system has been the risk classification system based on human vulnerabilities. Its purpose was to ensure that devices would be regulated in a proportionate manner, whilst maintaining a high level of protection of health. The aim was also to minimize any unnecessary bureaucratic burden imposed on manufacturers. A rule-based system was devised to allow manufacturers themselves to identify the applicable risk class without having to formally apply for a classification decision from a competent authority or a notified body. It was also based on the realization that it would be prohibitively expensive to impose identical regulatory controls on all medical devices irrespective of the risk involved. The risk class would determine the appropriate conformity assessment route available to the manufacturer to achieve CE marking.

This was initially implemented in the Directive concerning medical devices (93/42/EEC). The companion Directive on IVD medical devices (98/79/EC) did not contain a risk classification system as such. Instead, it established categories and lists of products allowing identification of the appropriate conformity assessment route. The new IVDR aligns the regulatory approach for IVD medical devices with that of the medical devices in general by establishing a set of risk-based classification rules.

The new rules are largely based on original work done by the Global Harmonization Task Force (GHTF). The GHTF document is helpful in improving the understanding of IVD classification because it provides a rationale for each of the rules.

There are some significant differences between the classification systems for medical devices and IVD medical devices under the new regulations. IVD medical devices cannot harm a patient directly in the same way that other medical devices can. The harm caused by IVD medical devices is indirect in the form of false positive and false negative results or incorrect quantitative results. Thus, the element of human vulnerability expressed often in anatomical terms is less evident in the IVDR classification. The emphasis is on criteria based on intended purpose. In addition, the use of medicinal substances is not a major factor in IVD classification as it is in classifying medical devices in general.

Another significant difference related to risk is that an IVD medical device can also endanger other persons than the patient if it fails to detect a highly contagious life-threatening agent.

Manufacturers of IVD medical devices will have to comply with the requirements of the new Regulation by 26 May 2022 in order to continue to place their devices on the European Union market. The main practical consequence of the new classification rules is that most IVD medical devices will need some form of certification by notified bodies. The timeline for compliance is more complex than suggested by the main compliance date of May 2022, but this does not affect classification decisions.

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