Devices are regulated by the EU list of Competent Authorities. CLASSIFICATION SYSTEM:
Medical devices are classified according to risk into Classes I, IIa, IIb, III, and IV. TIMEFRAME:
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. LICENSE VALIDITY:
Licenses issued in the EU are valid for five years. AUTHORIZED REPRESENTATIVE:
An authorized representative anywhere in the European Union is required. ADDITIONAL INFORMATION:
The Medical Device Directive is due to be changed in 2015.
For manufacturers who are either in Germany or have their Authorized Representative located in Germany, devices that have been CE-Marked are required to go through additional registration or regulatory processes, including product registration with the DIMDI (the local German competent authority), in order to receive market clearance.
Last updated on February 9 2015.
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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