Date of Application of the Regulations

Date of Application of the Regulations

The Medical Devices Regulation (MDR, Regulation (EU) 2017/745) is fully applicable since 26 May 2021, following the transition period. Please keep the revised deadline firmly in mind. The corresponding date of application of the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746) remains in May 2022. If you manufacture, distribute or procure medical devices, or have other responsibilities under the new Regulations, please take advantage of […]

Posted: August 31, 2021
Under: In Vitro Diagnostic Medical Devices Regulation (IVDR), Medical Devices Regulation (MDR)

Guidance on Unique Device Identification (UDI) System

Guidance on Unique Device Identification (UDI) System

The new Medical Device Regulations MDR (EU) 2017/745 and IVDR (EU) 2017/746 introduce a Unique Device Identification (UDI) system for medical devices. Main provisions related to the establishment of the UDI system are contained in Chapter III and Annex VI of the two medical device Regulations. Overview of the MDR (EU) 2017/745 UDI and device data sets and IVDR (EU) 2017/746 UDI and device data sets to […]

Posted: January 9, 2021
Under: Actor Registration, EUDAMED, Unique Device Identification (UDI)

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