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White Paper: What Are the EU MDR Timelines for Device Registration in EUDAMED?

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What to Know about Device Registration Timing in the EU Medical Device Regulation

Medical device manufacturers can start registering products in the EU EUDAMED database as of May 26, 2020, the Date of Application (DoA) for the EU Medical Device Regulation (MDR). In April 2019, two guidance documents were released from the EU Medical Device Coordination Group (MDCG) clarifying that:

• The device registration period of eighteen months for Legacy Devices with Medical Device Directive (MDD) or Active Implantable Medical Device Directive (AIMDD) certificates starts on the DoA or, if EUDAMED is delayed, six months after the EC announces that EUDAMED is ready.

• Upon a serious incident, a medical device must be fully registered in EUDAMED as a prerequisite to report a serious incident in EUDAMED anytime following the DoA.

Based on the information provided to the public, deadlines and specific scenarios for medical device registration in EUDAMED are summarized in this white paper.

To see the full document, please fill in the short form below.

Thank you! We hope you find this content to be of great value for your EU UDI documentation.

 

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