Borderline products are perennial issues for both regulators and industry because of their very nature – the regulatory path to market is hard to define and is inconsistent. Borderline products are those products that may, on their face, fall under more than one regulation or directive.
Borderline products are also those that may fall within the definition of a regulation or directive, but is otherwise excluded from its scope.
For medical products, cosmetics, and biocides, there are many products that could fall under more than one regulation or directive, especially when the product has multiple and divergent intended uses.
For manufacturers of these products, determining the correct regulatory path is crucial, because choosing the wrong one could lead to higher costs and a hazier market access path.
There are resources for these products’ manufacturers to help guide them in determining their market access path. The political structure of the EU ups the ante on borderline products, as the different member states have the ability to come to their own conclusions about different products.
In order to better harmonize the member states’ views, the EU Commission, member states, and other stakeholders come together to form the Working Group on Borderline and Classification. This working group’s mission is to examine the different cases that are brought to their attention and work to find a way to harmonize different viewpoints on which regulation covers which product, and the products’ classifications. The working group continually updates its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices, which includes medical devices, IVDs, biocides, and cosmetic products’ borderlines and classification issues.
Some competent authorities also publish guidance for manufacturers on their websites, helping manufacturers determine how a specific member state will treat their products. While not legally binding, these guidelines are used by competent authorities and notified bodies to answer the first question when placing a CE-mark on a product: what is it?
How to Determine Which Regulation or Directive to Use
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. However, correctly determining the regulatory scheme is an important first step, and it guides the manufacturer in choosing the conformity assessments and other steps to go through to place a CE marking on the product. 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 the manufacturer 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;
• The active substance(s), if any, used in the product;
• The concentration of the active substances;
• The level of efficacy of the active substance of the product; and
• The ingredients use and the concentrations at which they are used.1
Not all these points apply to every product. For example, medical devices and IVDs don’t have active substances. For medicines, cosmetics, and biocides, however, the substance itself and its concentration can be the determining factor in determining which regulatory scheme a product should follow. 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.
Where are the Borderlines?
The borderlines between each regulatory scheme and directive lie in the definitions and scope statements for each regulation or directive. These definitions and scopes are usually found in the beginning of each regulation or directive.
Medical Devices – Medical Purpose
The definition of a medical device is found in the Medical Devices Directive (MDD; 93/42/EEC) at article 1(2)(a). The MDD also states what it does not apply to, like IVD medical devices, medicinal products, cosmetics, and some human blood products.2 One part of the definition that creates a natural borderline is the requirement for a product to have a medical purpose in order to be a medical device. This medical purpose is usually found in the manufacturer’s intended use and its mode of action. For example, shoe covers that are specifically intended to be used in operating rooms or intensive care units are medical devices, whereas shoe covers that are intended to protect hospitals against visitors’ shoes are not medical devices. The difference lies in the intended use – the difference between protecting a patient, which is a medical use, and protecting a hospital’s environment, which is not a medical use. Another example that could fall into this gap is non-corrective contact lenses: depending on their intended purpose they may be medical devices or not.
In Vitro Diagnostics Medical Devices
The definition of an IVD medical device is found in the IVD Directive (IVDD; 98/79/EC) at article 1(2)(b). Restrictions to the IVDD’s scope include devices manufactured and used in the same health institution3 and products for general laboratory use.4 Products for general laboratory use are ones that often fall into a gap between the definition of an IVD medical device and a general laboratory instrument. For example, microscope slides and single or multi-channel pipettes are products for general laboratory use, even though they play an integral role in fulfilling the purpose of an IVD.
Medicinal products, or pharmaceuticals, are regulated by Directive 2001/83/EC and Regulation No. 726/2004. Directive 2001/83/EC defines medicinal products in Article 1(2), and includes the primary mode of action as pharmacological, immunological, or metabolic. This is different from medical devices, whose primary mode of action should be mechanical or physical.
Medicinal products run up against many different products’ regulations, including those for medical devices, cosmetics, and biocides. One key point is to focus on the products’ primary mode of action and intended use. One example of a borderline medical device/medicinal product is eye drops. Eye drops are medicinal products when meant to act in a pharmacological, immunological, or metabolic action, whereas they are medical devices if they are for cleaning, rinsing, or hydrating contact lenses.
Another example is a device that incorporates, as an integral part, an ancillary medicinal substance, like a bone cement that includes an antibiotic. The intended use of the product is to cement an implant to a bone. According to MEDDEV 2.1/3 rev 3, a medicinal product may assist a medical device, “...but as soon as these means are not ancillary with respect to the principal intended action of a product, the product no longer fulfills the definition of a medical device.” The antibiotic is there to make sure there is no infection, and while it’s important, the antibiotic isn’t the intended use of the bone cement. As a result, this is a medical device because the antibiotic is ancillary to the original intended use. Other examples of these types of products include catheters coated with heparin and soft tissue fillers that incorporate local anesthetics.5
The borderline between medicinal products and medical devices is also shared by drug delivery products. These products may be either a medicinal product or a medical device, depending on how the drug and the device are combined and the device’s intended use. Devices that are combined with the medicinal product and are intended exclusively for use in the given combination, which isn’t reusable, are medicinal products.6 Examples include pre-filled syringes, nebulizers that are pre-charged with a specific medicinal product, and patches for transdermal drug delivery.7 Devices that are meant to administer a medicinal product, without being exclusive as to the specific product, are regulated as medical devices. Examples include drug delivery pumps and implantable infusion pumps.8
Cosmetic products are defined by Regulation 1223/2009 of 30 November 2009 at Article 2(a). One key restriction on the scope of cosmetics is that they are not intended to be ingested, inhaled, injected, or implanted into the human body.9 Because of their nature, cosmetic products can also bump up against, and even create a gray area with, other regulations. One example is tooth whitening products. These products are cosmetic products because they lack a sufficient medical purpose to be a medical device. Another example is a pure cosmetic implant (as opposed to one that is for reconstruction) is excluded from both the Regulation on cosmetic products and the medical devices directive because it is implantable but lacks a medical purpose. The upcoming Medical Device Regulation closes this gap by including implants that may not have a medical purpose but act on the body similarly to medical devices. In the meantime, these products are in a regulatory gray area. Manufacturers of these types of products should consult with the individual member state’s competent authorities to determine how to proceed when placing their products on the market.
Biocides are defined by the EU Biocides Regulation (528/2012) in article 3(1)(a). By its scope, biocides cannot also be medical devices, medicinal products, or cosmetics.10 However, biocides still share some borders with these products, especially with products that may be medical devices or cosmetics but are also meant to disinfect. One example is wound irrigation solutions that are intended to kill microorganisms, as opposed to solutions that are simply meant to wash away debris. Those solutions that are intended to, or have properties that can, kill microorganisms are biocides even if without those claims they are medical devices. Another example is an antibacterial deodorant: deodorants are usually considered to be cosmetics, but are biocides when they claim to kill the bacteria that react with sweat.11
Borderline products that could be defined by more than one regulation, which creates problems for both manufacturers and regulators because they are difficult to define. Some borderline products that could reasonably fall under one regulation don’t because they are specifically excluded from that regulation’s scope. However, manufacturers can look at the different properties of their products, starting with their primary intended use and mode of action, as a starting point when faced with a borderline product. LNE/G-MED has extensive experience guiding manufacturers through this process, and has regulatory and technical expertise that covers each of these different regulations. If you have a borderline product and need regulatory or technical assistance, contact us.
1 Guidance on legislation: Borderlines between medical devices and medicinal products, MHRA. Guide to Cosmetic Biocide Borderline Products. Irish Medicines Board.
2 Article 1(5).
3 Article 1(5)
4 Article 1(2)(b).
6 MEDDEV 2.1/3 rev 3.
9 Id. at Art. 2(2).
10 Id. at Article 2(2).
11 Guide to Cosmetic-Biocide Borderline Products. Irish Medicines Board.