hi i'm peter sibelius the founder of medicaldevice

in this video i will show you what makes a product a medical device [Music] hi i'm peter sibelius the founder of medicaldeviceh2.com and this video is a part of my online course on design control for medical devices the link for this course is in the video description below before we get to it please click the subscribe and notifications buttons to not miss other useful videos from our premium online courses let's get to it you might have heard people from the quality assurance or the regulatory affairs department saying that we need to do this and we need to do that in this part i will be showing you where all this comes from and why it is important and it all starts with asking the question what is a medical device because all the requirements we talk about apply specifically to products that are considered to be medical devices so how could you determine whether a product is a medical device or not for the european market the answer to that question lies in the medical device directive and the medical device regulation and for the u.s market the answer is in the federal food drug and cosmetics act in these norms there are definitions of what a medical device is now if your product matches the criteria of those definitions it is a medical device and that in turn means that you have to meet the requirements of the directives regulations and the coordinate system regulation and other applicable us regulations that apply to medical devices let's look at what those criteria looks like in a very simplified flow chart there are two major factors that you would have to look at when trying to determine if your product is a medical device or not please note that this is a somewhat simplified process but it should give you an idea of what the process is like firstly as a manufacturer you need to work out what you intend your product to be used for meaning does the product have a medical purpose or is it intended to be used for birth control if it doesn't then it's not a medical device but if there is a medical purpose it might very well be a medical device but there is one more thing you need to consider before getting to that conclusion you have to define how your product achieves its primary purpose and this is what makes the difference between whether your product is a medical device or a medicinal product or pharmaceutical if the purpose is not achieved by pharmacological metabolic or immunological means the product is likely to be a medical device and then on the contrary if the primary mode of action is pharmacological metabolic or immunological the device is likely to be a medicinal product and if it is there are other norms that regulate your product now i've used the words likely to be a medici medical device and likely to be a medicinal product why do i say that well sometimes it's not entirely clear what kind of classification your product should have some might say that it's medical advice and others say that it's a medicinal product or is it maybe neither of the two being the responsible manufacturer you need to make up your mind what you think and document your rationale for that opinion if it's hard to decide it could end up being a competent authority that ultimately decides for you how your product should be classified luckily for most products it is not that hard to crack from a classification point of view but i won't say it never happens either so this is a heads up for you who think you might have a borderline product so what all this means is that if you intend your product to be used for diagnosis for example a thermometer therapy which could be band-aids or surgery let's say a scalpel or as a contraceptive like a condom and your product does not achieve its primary purpose by pharmacological metabolic immunological means it is probably a medical device even if your product is assisted in its function by a medicinal product it can be a medical device as long as the primary purpose is not achieved by the pharmaceutical component of your medical device please note that also standalone software and mobile phone apps can be medical devices assuming they meet the criteria of being a medical device as mentioned before there are legal definitions describing in detail what a medical device is in different markets you will find the european and u.s definitions and criteria below for reference now if your product is a medical device and you are planning to sell it to the european union you should meet the requirements of the medical device regulation or the mdr and if you're planning to sell to the u.s you should meet the requirements of the quality system regulation or qsr is there anyone in your network that might be in the process of developing something that may or may not be a medical device why not doing your network a favor by sharing this video with them on linkedin people might thank you for doing so and speaking of linkedin do follow medical devices too on linkedin there is a link to our company page in the description below thank you for watching just a reminder click the subscribe and the notifications button to make sure you always see new content from us do you want to know more about design control go to medicaldevicehq.com and sign up for my online course today i'm looking forward to seeing you there the link is in the video description if you think you learned something from this video like and share have any questions let me know in the comments thanks again i'm peter sebelius and i'll see you in the next video [Music] you Videolytics Tools