Making Sense Of The Muddle Of EU Device Registration Timelines
The recent document from the European Commission's Medical Devices Coordination Group concerning device registration timelines is difficult to follow, with its many unexplained references. This article aims to clarify how the MDCG's findings affect the way manufacturers should prepare for MDR compliance.
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April 2019 was seemingly a bumper month in terms of the amount of progress toward implementation of the EU Medical Device and IVD Regulations. There is now, finally, a sense that the sector is moving towards implementation of the MDR. But with so much left until so late, will enough progress be achieved in the time left?
Requirements for Unique Device Identification (UDI) will ultimately apply to all medtech manufacturers selling products in Europe. The upcoming mandates are complex and technical both for those developing UDI standards and for industry. Medtech Insight looks at progress so far on an EU UDI system, and sheds light on developments, terminology and how the system links together.
Latest information from the European Commission suggest that future notified bodies designated under the MDR, and even the IVDR, may not be in a position to issue certificates until March 2023.