Following the lifecycle approach of the MDR, the identification system aims to enhance the effectiveness of the post-market safety-related activities. The system brings about two key obligations: ...
On 15 February 2021, the European Commission published guidance on the Management of legacy devices in EUDAMED. This guidance addresses the registration and identification of legacy devices in EUDAMED ...
In a new position paper, the EU’s Medical Device Coordination Group (MDCG) has provided detailed information about device identifiers for eyeglass and lens manufacturers. The position paper is meant ...
Building off guidance released in March, the European Commission this month unveiled five new guidance documents on the use of unique device identifiers (UDIs). The guidances deal with UDIs for ...
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