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Medical Device News EU interesting developments – embracing MDSAP and UDI alignment

Marcelo Antunes

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Staff member
Medical Devices: The EU will take steps to make use of single audit reports (an initiative of the International Medical Device Regulators Forum – IMDRF) in a manner that is compatible with EU legislative requirements. The EU and US will cooperate to ensure alignment of electronic database specifications for Unique Device Identifiers (UDIs) and will develop a plan for bilateral test of compatibility of respective UDI databases, in concert with ongoing IMDRF efforts

From this report – EU-US Relations: Interim Report on the work of the Executive Working Group 30 January 2019From this document

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