Borderline Product Classification
While it may seem cavalier to focus an article solely based on one EU guidance document, it's a topic particularly worthy of study. The manual captures the discussion of the European Commission's Working Group on Borderline and Classification (composed of representatives from member states, the European Free Trade Association, and other stakeholders) and thus represents the consensus interpretation of certain borderline products. The classification manual was first released as Version 1.0 in April 2008 and re-released a month later as Version 1.1. One might get the impression that this document is revised frequently and published often. That said, until recently, no compilation of guidance on classification had been issued by the European Commission since July 2001 - the MEDDEV 2.4.1, Rev. 8, titled Guidelines on the Classification of Medical Devices. In addition, some of the borderline guidance was sorely in need of updating, having been last issued in April 1994 (MEDDEV 2.1.1). The Working Group has committed to periodically updating the manual as new decisions are reached.
Are They Medical Devices?
In the following examples, what would be the appropriate classification?
Case 1: Are the residual peroxide reagent strips and water reagent strips used to ensure that residual disinfection agents and water hardness, respectively, are at sufficiently low levels when testing hemodialysis machines considered accessories to the hemodialysis machine and, therefore, medical devices? If so, which class of medical device is appropriate?
Case 2: Are blood refrigerators that are used to store and preserve blood that is awaiting transfusion considered medical devices? If so, which classification is correct?
Case 3: What would be the appropriate classification for a warming blanket?
Still, Why Is the Manual Important?
Discussions related to the questions above are just examples of some of the important issues pondered and extensively deliberated by the Working Group. Borderline cases are situations in which a product's status is ambiguous, such as a medical device (MDD 93/42/EEC), an in vitro diagnostic medical device (IVDD 98/79/EC), an active implantable device (AIMD 90/385/EEC), or something that's not a medical device at all. Borderline cases also are defined to include circumstances where a product fulfills the definition of a medical device but is excluded by the Medical Device Directives (MDD) because of the product's scope. Classification is used to determine the appropriate rule in Annex IX, Classification Criteria, of the MDD 93/42/EEC.
The manual documents the European Commission's position on certain products and represents the positions agreed by the Working Group on Borderline and Classification (consensus among member state representatives and others) regarding "products, or categories of products, which have raised doubts." The manual is organized into seven sections: medically intended purpose of a medical device and an in vitro diagnostic device; the borderline between medical devices and in vitro diagnostic; medicinal product; biocides; cosmetic products; accessories to medical devices and in vitro diagnostic; and classification of medical devices.
The document is not legally binding. The only legally binding decisions are those of the European Court of Justice, which is the only body that is an authority of community law. It remains each member state's prerogative to review products on a case-by-case basis. In fact, the manual reminds member states that they must continue to render decisions under the supervision of the courts after considering all the characteristics of the product.
What Has the Manual Concluded?
In the example of Case I, the residual peroxide reagent and water reagent test strips are used in conjunction with the hemodialysis machine. The strips are used to assess that the disinfection agent residual levels and the water hardness levels are low enough to safely proceed with the hemodialysis procedure. However, in order for these two products to be considered an accessory to the hemodialysis machine, the accessory must be "necessary for the medical device to function." Based on the information reviewed, the group decided that the strips are not required to enable the functioning of the machine. For the strips to be an accessory to the medical device, the manufacturer must demonstrate that the strips are imperative to the proper functioning of the hemodialysis machine.
In Case 2, blood refrigerators that store and preserve blood that eventually will be delivered into the body are viewed as medical devices. In terms of classification, the rule that applies is Rule 2 (Annex IX). As a result, the blood refrigerators are classified as Class IIa.
The warming blankets discussed in Case 3 are medical devices, provided there is an explicit intended medical purpose. The warming blanket comprises two elements: a blanket and a generator. If the blanket and generator are sold as a single medical device, the warming blanket would be Class IIa or Class IIb according to Rule 9. The difference in classification is correlated with the status of the patient. If the patient is unconscious, the risk is greater (the example provided is the unconscious patient can't remove the blanket); thus, it is Class IIb. In a conscious patient, the medical device is Class IIa. If the manufacturer intended to separate the two elements, the blanket is a Class I medical device, Rule 1, and the generator would be Class IIa or Class IIb, Rule 9.
The above cases provide just a glimpse of the examples captured in the manual. The borderline and classification manual describes some of the consensus discussion, interpretation and opinions of the Working Group. It can be accessed from the following website: http://ec.europa.eu/enterprise/medical_devices/borderline_classification.... It outlines the group's position on certain products and, hopefully, assists manufacturers and regulatory professionals in understanding the European position. According to the manual, it is "one of many elements supporting the national competent authorities in their case-by-case decision on individual products."
November/December 2008
