Combination products, as the name implies, are products that share the attributes of two categories of products. In this article we will discuss the particular combinations of medical device and medicinal product. Let's start with a brief quiz. In each scenario below, would you consider the combination product a medical device, medicinal product or equally both?
- Contact lens care product that is indicated to disinfect, clean, rinse and hydrate contact lens
- Water to be used for injections, IV fluids and plasma volume expanders
- Syringe needle applicator and insulin form a single integral unit that is intended exclusively for use in the given combination for one-time administration of insulin and is not reusable
- Bone void filler to repair bone defects by which the primary action is a physical means (matrix) to provide a volume and scaffold for osteoconduction, where an additional medicinal substance is incorporated to assist and complement the action of the matrix by enhancing the growth of bone cells
The answers to the examples above are as follows: 1. medical device accessory; 2. medicinal product; 3. medicinal product; and 4. medical device.
Medical Device Combination Products Defined
Many recent publications have focused on combination products. Experts disagree about the strategy to regulate combination products but agree that they are immersed in a regulatory quagmire, being neither medical devices nor medicinal products. Statistics vary on the potential of this market, with estimates ranging from 10%-14% annual growth.
The pivotal concept is that a combination product is regulated in Europe by either the Medical Device Directive MDD 93/42/EEC or the Medicinal Product Directive 2001/83/EC (as amended by 2004/27/EC). (Note: The MDD text references the older Medicinal Product Directive 65/65/EEC.) For the most part, a general rule is that the primary mode of action (or function) of the product dictates how it is regulated. Therefore, a product never can be both a medicinal product and possess CE Marking.
Most RA professionals are familiar with the MDD definition of a medical device, so it will not be repeated here. Medicinal products according to Article 1.2 are:
"Any substance or combination of substances which may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacologic, immunological or metabolic action, or to making a medical diagnosis."
Indeed, determining if a product is considered a combination product can be challenging. Fortunately, a MEDDEV guidance document exists to advise if the combination product should be regulated by medical device or medicinal product standards. While MEDDEVs have no legal force, these documents facilitate common positions throughout the European Union. MEDDEV 2.1.3, rev. 2, July 2001 on Demarcation Between Directive 90/385/EEC on Active Implantable Medical Devices, Directive 93/42/EEC on Medical Devices, and Directive 65/65/EEC Relating to Medicinal Products and Related Directives was published in response to the contentious discussions on the borderlines between these directives during the legislative procedure of the MDD. The MEDDEV recommends the following questions be considered to categorize the product as a medical device or medicinal product:
- Intended purpose, including an assessment of the way the product is presented
- Method by which primary mode of action is achieved, substantiated by manufacturer's labeling and claims and scientific data on mode of action
Examples 1 and 2 in the quiz follow the definition of a medical device accessory or medicinal product, respectively. The MDD definition of "accessory" is Article 1.2(b). Essentially, an accessory is an article intended specifically to be used together with the device to allow the device to be used according to its intended use. An accessory is a medical device.