MEDALKAN products are CE marked
CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.
MEDALKAN products are CE marked in accordance with Directive 93/42/EEC and the MDR Regulation* (Council Regulation 2017/745/EU) for medical devices.
Since May the 26th. 2021, all medical devices commercialised in Europe must be in conformity with the regulation for medical devices MDR (EU) 2017/745.
These new provisions should ensure increased patient safety in all countries of the European Union. In addition, medical devices must meet these stringent requirements in order to be eligible for market authorisation and guaranteed availability for the patient.
MEDALKAN complies with the requirements of the new Regulation MDR (EU) 2017/745.