Throughout the many changes the EU Medical Device Regulations 2017/745 and 2017/746 will bring, one equally important is the introduction of a device traceability system based on Unique Device Identification, most commonly mentioned as UDI, within the healthcare supply chain.
UDI has been developed in order to allow the unambiguous identification of an individual device on the market and, even though it is detailed in Part C of Annex VI of the Medical Devices Regulation, there were still many unanswered questions in what concerns its applicability, deadlines to comply with these requirements and the overall procedure for registering a medical device.
In light of the above, the European Commission has published a FAQ document on the UDI system addressing the objectives of this new system, among which to ease the traceability of devices, facilitate the post-market surveillance activities, help decrease medical errors and support against falsified devices. This document will be under continuous update given the assessment of most frequently asked questions by the European Commission.
The listed information is of great use to all stakeholders of the healthcare industry in understanding the important changes brought by this new system of identification of devices and its intended application.
If you wish to know more about the Medical Device Regulation and the novelties therein, please do not hesitate to contact us.
Obelis Expert Consultants, with more than 30 years of experience with EU Regulations, will gladly answer any question you may have and will assist you in safeguarding your products’ compliance.
Junior Consultant, Regulatory Affairs & Quality Assurance Department
21st of January 2020
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