The differences among the international in vitro diagnostic (or IVD) medical device regulatory schemes can be confusing, especially when one jurisdiction views a device differently than another. It’s important to stay within the lines of the jurisdiction’s regulation and definitions of what it considers to be an IVD.
That said, there are a few products that may, at first blush, fit within the EU’s definition of what is an IVD medical device, but they are specifically excluded from the scope of the IVD Directive. These devices are called borderline devices, and IVDs aren’t the only types of medical devices that can have them. However, the borderline for IVDs can sometimes be a bit more difficult to see. This newsletter will explain some of the more prevalent IVD borderline EU regulatory definitions that can arise.
What is a Borderline IVD Device?
When planning on CE marking a product, the first point that a manufacturer should determine is which regulatory scheme to follow. In other words, the manufacturer should determine which product they actually have, according to the regulations and directives. For some products, this is easier than others. Each directive or regulation defines its particular scope both by stating what it applies to and what it doesn’t apply to, and defining the product that it covers. In many cases, this step is straight-forward: a product is either covered by a regulation or not, in which case it may be covered by another regulation. When it’s not direct, however, the manufacturer should conduct a more in-depth analysis in order to determine which regulation the product should follow. The points that IVD manufacturers should look at are:
• The intended use of the product (or its primary function) and its mode of action;
• The claims that the manufacturer makes about the product.1
From the definition it follows that in order to be qualified as an IVD the product must first fulfil the definition of a medical device and therefore must be intended by its manufacturer to be used for a medical purpose. Not all these points apply to every product. However, the key point in the EU medical devices and IVD regulations is that the purpose for which the devices are used must be for a medical purpose. This point helps to draw a couple borderlines, as described below. Manufacturers can also use guidance documents like the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices. This Manual draws the lines between the products and their regulations to help manufacturers and authorities, and points out specific examples of borderline products.
Research Use Only Products
Research Use Only IVD products are those that have no intended medical purpose or objective with regards to the IVD itself. In other words, RUO IVD products are IVDs that are used for research purposes only, and not for an in vitro diagnostic examination or a medical purpose. According to MEDDEV 2.14/2 rev. 1, some examples of RUO IVDs are products used in pharmaceutical research to verify reactions to compounds, products used in basic research to understand the underlying mechanisms of human life, and products used to identify and quantify individual substances in specimens. The common thread that these examples have is that the device’s purpose isn’t to diagnose a physiological or pathological state in humans; it’s to determine how something else (that isn’t the IVD itself) works.
Specimen receptacles are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.2 According to the IVD Directive, specimen receptacles are included in the definition of an in vitro diagnostic device. But not all specimen receptacles are created equal. For example, specimen receptacles that come into contact with a patient or are invasive are considered to be medical devices (not IVD medical devices) and regulated under the Medical Devices Directive. This include