Observe Medical receives MDR certification under the new European Medical Device Regulation
Oslo, April 1, 2022 – Observe Medical ASA ("the Company" or "Observe Medical") today announces that the Sippi® Disposable Unit has received Medical Device Regulation Certification, ensuring continued market access for the unit in Europe after 2024. Rune Nystad, CEO of Observe Medical, commented: "The MDR Certification confirms that the Sippi® Disposable Unit is compliant with the latest requirements for medical devices in Europe. This is important as it demonstrates our commitment not only to adhere to the latest regulatory compliance but also to ensuring our clients that we deliver