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Devices are regulated by the EU list of Competent Authorities.
Medical devices are classified according to risk into Classes I, IIa, IIb and III.
The 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.
Licenses issued in the EU are valid for five years.
An authorized representative anywhere in the European Union is required.
Hungary is one of the EU Member States. If the medical devices intended to be marketed in Hungary are covered by MDD and if the procedures (conformity assessment, registration) have been conducted according to the provisions of the MDD (e.g. in UK or in one of the Member States of the EU), then marketing of the medical devices shall be possible. No further registration or conformity assessment is necessary in Hungary.
Last updated on June 4 2018.
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For more information on registration in the EU, check out the following articles on our blog:
5 Questions and Answers: Additional Regulations in the EU
4 Steps to Comply With EU Directive RoHS 2