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 includes products like blood lancets and oral swabs.
General Laboratory Use Products
Products for general laboratory use are specifically excluded from the definition of IVD devices in the IVD Directive, unless the manufacturer intends that they be used specifically for in vitro diagnostic examination.3 General laboratory equipment is those products that can be used in a laboratory for essentially any purpose, including preparing samples. MEDDEV 2.14/1 rev. 2 gives examples of general laboratory equipment, like general centrifuges, pipettes, plastic tubes, empty ELISA plates and petri dishes, scales, and mass spectrometers. What will bring these products into the scope of the IVD directive is the intended purpose: plastic tubes for the purpose of collecting human blood are IVDs, whereas plastic tubes for any use are general laboratory products.
Law Enforcement Drug Tests and Biological or Chemical Warfare Agents
For a product to be considered an IVD within the scope of the IVD Directive, it must have a medical purpose. Law enforcement is not a medical purpose according to MEDDEV 2.14/1 rev. 2. As such, devices that are intended to be used only in the course of law enforcement are not IVDs within the scope of the IVD Directive. Likewise, paternity tests or drug tests used by company’s HR departments are also not IVDs within the scope of the IVD Directive. For this same reason, devices for detection of agents of biological or chemical warfare are not IVDs within the scope of the IVD Directive because they don’t have a medical purpose. An example of these types of devices is the swabs used by airport security screeners to test for residues on hands and suitcases.
Kits with IVDs
IVDs are sometimes used in conjunction with other products, together known as kits. Depending on what those other products are, the entire kit is considered to be an IVD within the scope of the IVD Directive, or only the IVD itself is considered while the other parts fall under another regulation. According to MEDDEV 2.14/1 rev. 2, kits are classified and assessed according to the principal intended purpose of the combination, and it is the entire kit that would receive the CE marking. However, sometimes kits include products that clearly are not included in the scope of the IVD Directive, like medical devices or general laboratory products. For IVD kits that include medical devices, the medical devices themselves must be CE-marked according to the Medical Devices Directive, and then the combination would be CE-marked according to the IVD Directive. General laboratory products can also be included in kits with IVDs, but wouldn’t be CE-marked in their own right.
The proposed EU regulations on IVDs aim to erase some of these borderlines by specifically including, or excluding, some borderline IVDs. In the meantime, however, relying on LNE/G-MED’s regulatory guidance and the medical purpose of the product could help an IVD manufacturer to define what type of product they have.
For more information on the services that LNE/G-MED offers to IVD manufacturers, contact us.
1 Guidance on legislation: Borderlines between medical devices and medicinal products, MHRA. Guide to Cosmetic Biocide Borderline Products. Irish Medicines Board.
2 98/79/EC Art. 2(b).