As mentioned in our Classification and Grouping Guide, there are a series of rules to consider when classifying and grouping medical devices. The above-mentioned rules are fully explained in Appendix II – Supplement of medical devices of the Mexican Pharmacopeia (FEUM).
In this article we will focus on explaining strategies to classify and group a stent following simple general rules. We also detail some particularities that can be found according to our everyday experience.
General characteristics of a Stent
Stents can be sold mounted in balloon catheters or alone. The common practice is to find them in the mounted presentation. The material is generally of medical grade stainless steel or a cobalt alloy metal. These can even include a drug with the purpose to avoid stenosis. On the other hand, they are sold in sterilized tyvek pouches and in different sizes, by means of the catheter length and stent diameters (gauged in Frenchs).
On the other hand, manufacturers tend to sell the stents with different commercial names. This is related to alternative technologies or intended uses.
Finally, it is worth mentioning that the stent is used in a catheterization procedure and there are a set of supplies related to the process (e.g. pressure transducers, guide catheters, introducers, etc.). These products are not sold under the same commercial name of the stent or included in the same package.
Every point described so far has regulatory implications that we will explain in the following section.
Classification according to the level of risk
Stents by its nature are classified as implantable medical devices and due to their level of risk are considered Class III based on rule 8. This is applicable for any type of stent (medicated or non medicated, for cardiac catheterizations or others).
Grouping for Sanitary Registration purposes
The classification for a Stent is pretty straightforward. Yet, it is still necessary to consider a few points regarding the grouping criteria. Specifically, stents can be grouped in the same Sanitary registration if they:
- are made by the same manufacturer,
- have the same brand name or trademark and the same intended use and
- are manufactured with the same materials and technology.
When the same brand name is sold for the medicated and non-medicated version, one registration is necessary for each product -keeping in mind that the mentioned grouping criteria prevails. Regarding the medicated stent version, it is important to point out that these products require a separate evaluation of the stent as a device and pharmaceutic product.
As a side comment, balloon catheters are also commercialized without a mounted stent for angioplasty procedures. Such balloon catheters without a stent are considered Class II medical devices based on rule 6. Nevertheless, we have found precedence of other devices as Class III.