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New guidance documents from the Medical Devices Coordination Group

Posted on 28.02.2019

The Medical Devices Coordination Group (MDCG) recently published a short guidance on the content of the certificates and voluntary certificate transfers, which can be found here. This short document explains the importance of providing traceability to common specifications and harmonised standards, even if they are not listed on the certificate itself. For voluntary certificate transfer from one notified body to another: while full conformity assessment procedures may not be needed if the incoming notified body receives sufficient information, the document outlines some minimum procedures which should be followed.

The MDCG also endorsed additional/updated guidance documents which support the Unique Device Identification implementation under the upcoming IVD and MD Regulations:
1. MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI (January 2019)
2. MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017 (February 2019)
3. MDCG 2018-1 v2 Draft guidance on basic UDI-DI and changes to UDI-DI (February 2019)