Highlights and tips by Nicole Häusler, eHealth HUB Regulatory team
In our opinion, manufacturers of digital health technologies need to carefully consider whether their technology is a medical device and if so how it has to be classified and what steps have to be taken to get the CE mark.
We realized during the last two years that this can be a difficult endeavor as many standards, guidelines and regulations are involved. Manufacturers have to stay focused, have to contemplate their product from another angle - and have to spend money. All of this can slow down the process of CE certification which in the end slows down marketing.
One interesting aspect we learned from our experts is the idea to first focus on a product version which allows to launch the first product without CE certification and later on certify the product with extra functionalities. This might be an interesting option also for other SMEs. So, if you need help, please register here and contact us at eHealth HUB.
Know more about the eHealth HUB Regulatory Guidance and ask for support!