Is a medical device defined the same way in all countries? How are medical devices classified? Can classification decisions be disputed?
The answer is as big as the question, and will usefully be divided into four sections: quality assurance, Canada, the United States, and Europe.
This question is too large to be answered fully in this column. First of all, it is important to qualify that the definition of “medical instrument” varies from country to country, though there is a common basis. For example, a device that analyzes the quality of mother’s milk will probably be seen as a medical device in the United States, but not in Canada or Europe. That does not mean, however, that the U.S. has stricter guidelines; for instance, Canada will classify a hypoxic chamber as a medical device, while the U.S. will not, and European countries will be divided. Based on their definition, but also on their past experiences and their fears, the regulatory authorities will be requiring more or less for a product.
For the same reason, although Canada’s four-part classification system (classes I, II, III, and IV) corresponds roughly to the European system, with its classes I, IIa, IIb, and III, there are differences of interpretation, and therefore in classification, between the jurisdictions. There is also a difference in the number of device classes in some countries. For example, in the United States, there is only three classes: I, II, and III. Class II essentially corresponds to the two intermediate class of the Canadian (II/III) and European (IIa/IIb) systems.
As if things were not confusing enough already, different standards (such as the IEC 60601 family of standards) may be either optional or compulsory for medical instruments, and some of these standards might themselves contain a definition of what constitutes a medical device, as well as the classifications of these devices.
Given all this, what must one do? The analysis to perform is based on the suggested use of the instrument. For example, the FDA will view an instrument used to diagnose tooth decay differently if its intended use is “diagnosis of cavities” as opposed to “aid in the diagnosis of cavities.” A simple rewording such as this can change the class of, and the demands applied to, a product. As your choice of indicated use will have to be respected in the marketing of the product, it is important to optimize the commercial impact while simultaneously minimizing the difficulty of gaining regulatory authorities’ acceptance of the instrument. You might want to consider a multi-steps certification strategy to start selling your product faster while still trying to obtain a more requiring indicated use.
After having established the list of potential indicated uses for a device, one must reread the definitions of “medical device” as they apply to each of the targeted territories and verify if it is in fact, a medical device—and, if this is the case, determine in what class it falls.
In Canada, this entails reading the Medical Devices Regulations, particularly Appendix 1 (http://www.hc-sc.gc.ca/dhp-mps/md-im/legislation/index_e.html). To determine the classification, you can consult a keyword index
(http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/keyword_motscles2_e.html). Finally, you can confirm the information by contacting Health Canada directly.
In Europe, you must read the Medical Devices Directive (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:EN:NOT), particularly Appendix IX. It’s generally easier to use the two classification guidances http://ec.europa.eu/enterprise/medical_devices/meddev/2_2_4-1part1_07-2001.pdf and
http://ec.europa.eu/enterprise/medical_devices/meddev/2_2_4-1part2_07-2001.pdf. If necessary, you may also contact a notify body or the medical authorities of a European Union member country. The wait is fairly long (sometimes up to four months), whereas it typically only takes several days to hear from Health Canada.
In the United States, you must consult the Code of Federal Regulations Title 21 database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm) or the FDA’s medical instrument Search Classification Database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm). If needed, you can also contact a representative of the FDA Division of Small Manufacturers, International and Consumer Assistance.
You can challenge regulatory authorities’ decisions as to whether devices are medical instruments, as well as their classifications decisions. To succeed at reclassifying a device, however, one must always have excellent reasons. For instance, if 10 other instruments similar to yours have already been accepted into Class II in Canada, you don’t really have a chance of yours being in Class I. On the other hand, if your product is completely novel and you have solid arguments, the regulatory authorities might accept your point of view. You should generally assess the additional work that would be required by the higher class and evaluate whether it’s worth the investment of time and money, even if you think you’re right. It’s also worth noting that it’s sometimes preferable to establish a precedent that your competitors will be less likely to be able to meet.
Dr. Emmanuel Montini
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