The UDI system, which will be phased in over several years, offers a number of benefits that will be more fully realised with the adoption and integration of UDIs into the health care delivery system. UDI implementation will improve patient safety, modernise device postmarket surveillance, and facilitate medical device innovation.
Compliance Dates
An update from the FDA on compliance dates can be found here.
It is expected that the EU requirements for UDI will be similar to those of the FDA with a compliance date of 2017 (phased approach based on risk class of medical device).
AIS Experience
Our team of experienced engineers have worked with several of the leading US multinational medical device companies, based in Ireland, to implement the UDI requirement into their businesses.
Should you have a similar requirement, and need to speak to one of our experienced Engineers, please call us on 01-6205742 or 028-90718912 from NI. Alternatively, please email info@aisltd.ie.