2010年 11月 23日
There is no shortage of innovation in the medical device industry. Entrepreneurs and existing companies are inventing new ways to improve patient care faster than ever. Venture capitalists have helped the flood of ingenuity, pumping billions into emerging medical technology companies. Much of the growth is driven by solutions created to serve an aging population. But the boom in the cosmetic and therapeutic industries has created its own wave of devices, many of which are making their way onto the international scene by way of China, where such devices have been commonly accepted for years.
The stream of innovation often produces devices that may not seem like devices at all. This often leads to confusion among manufacturers, who wonder whether a specific product is regulated as a device, a drug, a cosmetic, a combination device or neither.
In some cases the answer to "is it a device or not?" and applicable classification is very clear. Sometimes, however, it is not as obvious, and making the wrong decision can sometimes lead to surprises that have costly consequences.
The confusion increases when manufacturers are under the presumption that device and classification rules between the United States and Europe are identical. In most cases, the US classification of your device by the FDA will hold true in Europe-but not always. In the case of a nasal spray, for example, making simple formulation changes ensured that the device acted as a mechanical barrier against airborne pathogens and allowed the spray to be classified as a medical device. As a result, this saved the manufacturer hundreds of thousands of dollars, since the alternative was to be regulated as a drug-which requires a more costly and lengthy review process. In the case of synthetic dye, it is sometimes difficult for manufacturers to understand that a liquid or a cream (wound care products, for example) could be considered a "device." Many people perceive a device as something that you can hold in your hand (ie, not a liquid, cream or software). It also is not uncommon that manufacturers may be driven by marketing reasons (tariff advantages) and, therefore, push the envelope in their justification to classify their product as a device, even though this may not be the case.
For more than 90% of products, classification is very clear. Still, certain products cause confusion, and what may seem like an ordinary device might be considered a medical device or a drug (or combination, such as a drug-eluting stent) depending on claims and how it is used.
With regard to needle destruction devices, for example, these are not considered medical devices in Europe but are Class III in the United States. This implies a fairly straightforward compliance process in Europe for needle destruction devices, mainly consisting of testing the unit to electrical safety and electromagnetic compatibility (EMC) and declaring CE compliance to the respective Low Voltage and EMC Directives. In the United States, these devices require premarket approval (including clinical trials), long timelines and a high cost to get to market (the price tag can be more than $250,000).
Sterilization trays are considered accessories under the European device regulations. The definition of an accessory is described in the Medical Device Directive as follows: "...means an article which while not being a device is intended specifically by its Manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the Manufacturer of the device." As such, accessories are within the scope of the directive and require the CE Marking.
The general rule of thumb is that an accessory to an accessory is not considered to be a medical device. In the case of sterilization trays, if the intended use by the tray manufacturer is that the tray is solely intended to be used with a specific or generic autoclave, the tray would be considered an accessory to an accessory-in other words, the autoclave is an accessory to medical devices. However, if the tray is specifically intended by the manufacturer to be used with a specific medical device, such as trocars, then the tray is considered to be an accessory to a device and is within the scope of the directive (Class I).
The same can be said for flexible hoses for respiratory, anesthesia and other medical equipment. The question of classification of such an accessory is whether the hose should take on the classification of the device (which could be Class IIa or higher). The directive states that accessories can be classified in their own right. In the case of the flexible hose, this would considered a Class I product. However, it is not uncommon to see disputes between the different EU member states authorities about the classification of accessories in this regard.
Dental splints, as another example, are intended use is to prevent grinding of the teeth. In both the United States and Europe, these splints are considered to be Class I devices. However, when the manufacturer would add a claim that the splint also prevents migraines, now the FDA would consider this to be a Class III device, while in Europe the splint remains Class I. Although Europe regulations require that you can justify your claims, the classification of the device is not determined by whether it prevents grinding your teeth or whether it prevents migraines.
These examples highlight a fundamental difference in the way Europe and the US FDA go about the process of classifying devices. In the United States, the FDA classifies every product individually. In contrast, Europe does not classify individual medical devices. Instead, Europe follows a set of criteria and created classification rules based on these criteria, which manufacturers can apply to their device. There is no database of medical device classification in Europe-yet. The European classification categories are similar to the United States, however.
In Europe, classification is determined using a set of rules that can be found in Annex 9 of the Medical Device Directive. How you answer the questions in Annex 9 will determine the classification. Classification is essentially determined by:
All rules in Annex 9 are intended to determine the level of risk inherent in your product. However, risk also depends on who will be using the product (professional or patient), its mode of operation, the sophistication of its technology and the marketplace in which your device is being introduced. Despite the initial classification for your device as confirmed by you or your notified body, national ministries of health have the right to up-classify a device if they feel the technology is fairly new to their market and, therefore, presents a higher risk to users than it would in other parts of Europe where the technology is widely used.
With increased globalization, Europe and other countries have been working toward creating a unified definition of what is a medical device and working toward identical classification rationales. Study Group 1 of the Global Harmonization Task Force has proposed standardizing how devices are classified, including a switch to classifying devices into categories A, B, C and D from Class 1, 2a, 2b and 3. It remains to be seen whether Europe and other GHTF participant countries will adopt their recommendations.
In conclusion, the first regulatory step toward European device compliance is to determine whether your device is considered to be a device and, if so, what the classification will be for Europe. You simply cannot let this determination be based on the US classification of your device.
For more information about the European classification rules, please review the European Classification Guideline for Classification MEDDEV 2.4/1 REV 9.