Medical product or medical device?

In a presentation at the Emerging Technologies Conference at the Advanced Textiles Association’s Expo 2025, Alexander Laubach, a chemist with the Hohenstein Institute, took his audience behind the scenes to help clarify the differences between medical products and medical devices, and to outline the process that must be followed for approval.

Identifying a medical device is “all about the intended use,” he says. “Things you can materially touch, you should consider that you could have a medical device,” Laubach says. The EU, U.S. and Canada “are really close to each other,” he says. In fact, in the EU they often follow The U.S. Food and Drug Administration (FDA) regulations because they’ll meet EU, as well. 

Still, FDA vs. EU Medical Device Regulations (MDRs) are “not very clear,” he says, and variously address needed documents, labelling and the submission process itself, after which the determination—device or product—is made. In the U.S., the FDA separates them in three classes: Class 1, low risk; class 2, moderate risk; class 3, high risk. In the EU, there are four MDR classifications from low to high risk. 

If it’s a medical device, the next step is to prove that it’s safe. Biocompatibility is at the top of the list. “You really have to test for that,” he says. There is a detailed process outlined for proceeding with this step, starting with a Biological Evaluation Plan, followed by Planned Testing.

Laubach also explained targeting vs. screening in the testing process. Targeting is searching for a specific substance, where “the point is to get precise answers,” he says. Screening is a general search for all substances, for “a semi-qualitative and quantitative result,” he says, because “the challenge is in the unknowns.”

A chemical analysis follows, which is checked against a Restricted Substances List (RSL). Eventually, the data will be assessed according to toxicological risks, considering, in brief, detected substances above the Analytical Evaluation Threshold (AET), maximum tolerable exposure, an estimation of patient exposure and the margin of safety. The process ends with a Final Risk Assessment and Report.