Legacy Devices In Eudamed Database: MDCG Proposes Regulatory Solution
The new EU medical device regulations ̶ the MDR and IVDR – left a gap in how manufacturers of legacy products should comply with critical reporting requirements. A solution has been found.
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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?
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-one new guidance documents have been posted on the tracker since its last update.
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.