The EU Commission issued Q&A document for Unique Device Identification (UDI) System. This guidance document gives an overview of the new UDI system and obligations of operators, which have to be fulfilled to CE Mark a medical device. For other details you can check our article “How to CE Mark a Medical Device”
The UDI system will be applicable to all medical devices within the EU market except custom-made and performance study/investigational devices. The mandatory deadline for a medical device to comply with the UDI requirements is summarized on question 6 of the document.
Deadline for a medical device to comply with the UDI requirements
Please not that , if you will be using the transitional provisions of MDR or IVDR, you will be obliged to submit the UDI data in the EUDAMED database on 26 November 2022 for a medical device. (26 November 2023 for an IVD medical device). Of course, this obligation will be only applicable if EUDAMED is fully functional before the date of application of the respective Regulation. If not, it will be applicable in 24 months after EUDAMED has become fully functional
The new system will bring many advantages to the medical device sector. As defined on the first paragraph of the guidance document;
“The UDI system will facilitate easier traceability of medical devices, significantly enhance the effectiveness of the post-market safety-related activities for devices and allow for better monitoring by competent authorities. It will also help to reduce medical errors and to fight against falsified devices. The use of the UDI system finally should also improve purchasing and waste disposal policies and stock-management by health institutions and other economic operators”
This Q&A document gives a brief summary of the regulatory background for MDR 2017/745 and IVDR 2017/746.Therefore, if you are not aware of UDI requirements applicable to your medical device, this document might be very useful starting point for you.
The document includes 16 questions and related answers on basic requirements.
If you need further information about CE marking of your medical device and UDI related questions do not hesitate to contact us. Our experts will be happy to help you.