REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Cyprus, devices are regulated by the Department of Medical and Public Health Services under the Ministry of Health.
CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III.
TIMEFRAME: The EU registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years.
AUTHORIZED REPRESENTATIVE: An authorized representative is required anywhere in the European Union.
ADDITIONAL INFORMATION: On April 5, 2017, two new Regulations on medical devices were adopted, these entered into force on May 25, 2017 and replaced the existing Directives. The new rules will only apply after a transitional period, namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
For products that are already registered in a European Country, bear the CE mark and are accompanied by all the relevant certificates, all products placed on the Cypriot Market must be notified to the Cyprus Medical Devices Competent Authority.
