SciBase Holding AB (“SciBase”) [STO: SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today, that an article describing the consequences of the new medical device regulation (MDR) in the EU has been published in the journal “Journal of the European Academy of Dermatology and Venereology” (JEADV).
The new MDR regulation that came into force on May 26 2021 will have significant effects for the medical device industry and for clinicians, including Dermatologists. Firstly, many more products, especially software or app-based products require regulatory approval and control. This affects many products within Dermatology that previously were not regulated. There are also more stringent requirements within clinical evidence and the approval of product changes.
MDR will most likely have positive effects on the quality of devices, to the benefit of patients, but may also have effect on the availability of new and existing devices and methods. SciBase is one of very few companies in the field of dermatology that is certified according to the new more stringent MDR regulation.
“We believe this article will help the Dermatology field understand the implications of this new regulation and how it will affect their access and use of products, which in turn can affect the care they give their patients. I think this will affect the buying decisions of clinicians, and that they will be much more likely to purchase from MDR-certified companies.” says Simon Grant, CEO of SciBase
The article was a collaboration between Dermatology clinicians and regulatory experts with input from SciBase and can be found at the JEADV journals homepage: https://onlinelibrary.wiley.com/doi/abs/10.1111/jdv.17830
