It is not for nothing that the correct formulation of the intended uses of medical devices is crucial for their successful development and official approval. In this article, we will discuss the intended use of medical devices with reference to the regulatory framework of the European Medical Device Regulation (EU) 2017/745. While the U.S. FDA uses the terms «intended use», «intended purpose» and «intended use» are often used interchangeably in the EU, and both terms are mentioned in the MDR. MDAG Guide 2020-6 finally removed the ambiguity resulting from the random use of the term «intended use» alongside the more frequent «intended use» in the MDR. Mike Drues: Often, what we want to say from a regulatory perspective is diametrically opposed to what we want to say from a reimbursement perspective. So we might be able to market a scalpel through the FDA as a Class I for a general surgical indication, but I guarantee that when it comes to the Centers for Medicare & Medicaid Services, CMS, which sets reimbursement codes, they won`t reimburse that scalpel unless it`s specifically labeled for the eye. So that`s the dance, that`s the discussion we all need to have in our companies, where we play in this room. Jon, do you have any other comments on that? The intended use helps identify clinical data relevant to the device and the depth and scope of clinical evaluation depends on the intended use (as well as the classification, risks of the device, and manufacturer`s claims about the device). Two terms that are often confusing (and often mistreated as interchangeable) are «intended use» and «directions for use».
The words intended uses or words of similar meaning in sections 801.5, 801.119 and 801.122 refer to the objective intent of the persons legally responsible for labelling products. The intention is determined by the statements of these persons or can be proved by the circumstances of the dissemination of the article. This objective intent may be demonstrated, for example, by marking allegations, promotional material or oral or written statements by such persons or their representatives. It can be demonstrated by the circumstances that the item is offered and used with the knowledge of those persons or their representatives for a purpose for which it is not marked or announced. The intended use of a product may change after it has been introduced into international trade by its manufacturer. For example, if a packager, distributor or vendor intends to use an item for uses other than those intended by the person from whom it received the products, that packager, distributor or vendor is required to provide appropriate labelling for the new use. However, if a manufacturer is aware or has knowledge of facts which inform him that a product which he has imported into trade between Member States is intended to be used under conditions, purposes or uses other than those for which he proposes it, he shall provide for appropriate labelling for that product which is compatible with other uses, for which the object is to be used. Which brings us to «purpose» and «application notes.» Jon Speer: That`s right. All right, thank you Mike.
My thoughts are, understand that the intended use and your indications will impact your design control, product development, risk management, everything you`re going to do to get that product to market, it really starts with what you claim your product will do, and it will infect your product classification and all the things you`re going to do afterwards. So, be smart about it. Of course, if you have any questions about it, you can master Mike Drues, you can find Mike very easily. Well, just look up his name, his last name, D-R-U-E-S. Mike writes for a lot of industry publications, has podcasts, and [laughs] as much as he`s traveled, he could be anywhere near you every day now. [laughs] Imagine if you had a way to get to market faster, as long as you clearly defined your intended use and instructions for use? No one wants to ruin their conditions and compromise the speed of a product`s launch and regulatory compliance. Section 7 of the MDR prohibits misleading the user or patient as to the intended purpose of the device by giving credence to functions on the device, creating an erroneous impression about the treatment or diagnosis that the device does not have, or failing to disclose likely risks and proposing uses for devices other than those intended for the intended use. It`s time to break down the how and why of the intended use and instructions for use of your new medical device. Mike Drues: Absolutely. And in the second half of your question, on the usage indication page, it`s a little more, since the name would imply the reasons or situations in which we would use that particular device. And by the way, these terms are not just for medical devices, we use the same terms for drugs and biologics and combination products.
There is. Some people, and sometimes even myself, will use the intended use and indications for use interchangeably. There is some overlap, but they are not the same.