14.12.2021
To the attention of Romanian hospitals and all interested parties
Invitation for hospitals to explore traceability solutions for non-sterile surgical sets – Solutions to capture full Unique Device Identifier (UDI-DI and UDI-PI)
The new EU regulations of MDR 2017/745 introduce a medical device identification system based on a unique device identifier (UDI), which allows easier traceability. These regulations require healthcare facilities to store and preserve, preferably in electronic format, UDIs of devices they have provided or which have been provided to them, if those devices are class III implantable devices. For implantable devices other than Class III, Member States shall encourage and may require healthcare institutions to store and retain, preferably in electronic format, the UDIs of the devices provided to them.
In order to find the best solutions for implementing these requirements within hospitals, following the request of the European Commission, it was decided to form a group of stakeholders from hospitals and medical device manufacturers, which will be led by MedTech Europe.
Please find attached the invitation to participate in this group.
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