Is it a medical device, or not?
When it comes to the European market, the medical device manufacturer should study the Medical Device Directive and the Medical Device Regulation. On the other hand, in the United States, the Federal Food, Drug, and Cosmetics Act defines what exactly constitutes as a medical device. In simple terms, in order for the product to be considered a medical device, it must match the criteria stated in the mentioned regulations.
In determining whether a product is or is not a medical device, there are two major factors that impact this classification:
- Does the product have a medical purpose?
If it does not, it is clearly not a medical device. However, if it is, it might as well have a medicinal purpose as well. So, how to make a distinction between the two? There needs to be a clear answer to the question:
- How does the product achieve its primary purpose?
This is the best way to see the difference between a medical and a medicinal, or a pharmaceutical product.
In other words, a product is likely considered to be a medical device if its purpose is not achieved by pharmacological, metabolic, or immunological means. On the other hand, if the primary mode of action is pharmacological, metabolic, or immunological, it is likely that the device is a medicinal product. Sometimes, it is not entirely clear what kind of classification a product should have. Some might say it is a medical, others that it is a medicinal product. Sometimes, it is neither. In that case, the manufacturer needs to decide, or have a competent authority decide for them.
Restating with examples
Luckily, it is usually not extremely hard to decide, from a classification point of view; yet, the manufacturer should be careful, in case what they make is a borderline product. Therefore, if the product is intended to be used for:
- diagnosis (e.g., thermometer)
- therapy (e.g., band-aid)
- surgery (e.g., scalpel)
- contraception (e.g., condom)
and, once again, it does not achieve its primary purpose by pharmacological, metabolic, or immunological means, it is probably a medical device.
Finally – the product can still be classified as a medical device even if it is assisted by a medicinal purpose, as long as the primary purpose is NOT achieved by the pharmaceutical component of it. Standalone software and smartphone apps can also be medical devices, assuming they meet the appropriate criteria.
Once again, there are detailed legal definitions that describe what constitutes as a medical device in different markets. If the product is a medical device planned to be sold to the EU, it should meet the requirements of the Medical Device Regulation, the MDR. For the US market, it is supposed to agree with the Quality System Regulation, the QSR. Did you like this article? You can read more of them here.
Would you like to learn more about Design Control?
Get instant access to our online Design Control for Medical Devices course right here. In 6 hours, you can learn more about how to develop new medical devices and maintain them in organisations where design control requirements apply. This course is taken by quality assurance, project management, design engineering or those involved in R&D and product development teams.
Peter Sebelius is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that is revising the ISO 13485 and ISO 14971 standards.
He has vast ‘hands on’ experience, having developed, amongst other things, a mechanical chest compression device and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.