As you may have already heard, the European Commission stated that EUDAMED’s launch will be delayed to the date of application for in-vitro medical devices in May 2022. Read the official statement.
Nevertheless, the date of application of the EU MDR remains May 2020 and based on current information the upcoming certification processes under MDR will require the Basic UDI-DI (e. g. as identifier on technical documentation). MDR also states that in case of a recall or FSCA all UDI data need to be submitted upfront, although it is not clear yet how this process will be handled when EUDAMED is delayed.
In order to be prepared for these scenarios, establishing a setup for the UDI data governance process in your company will be unavoidable, because you need to classify and re-organize your product portfolio to identify the right grouping of your products under one Basic UDI-DI and you also need to have the product specific attributes at hand.
As you can see, the delay mainly affects the data exchange with EUDAMED, not the future necessity of UDI as soon as EU MDR becomes applicable. Therefore, despite the delay of EUDAMED, the topic UDI still has a high relevance for EU MDR. For this reason, we recommend Medical Device Manufacturers to implement an UDI solution for EU MDR in their company.
Meanwhile our customers decided to proceed with their implementation projects for our UDI Platform EUDAMED Content Package as planned – adjusted to postpone all data exchange processes until final changes are communicated by the EC. As a major achievement, we are proud that one of our clients is already live on our UDI Platform with EUDAMED Content Package and is now able to generate Basic UDI-DI’s and maintain UDI attributes in order to be ready for the above mentioned scenarios.
Beyond this, it’s also important to keep in mind that UDI evolves currently to a global challenge. In addition to continuing the implementation project, we will work on further UDI projects to meet the upcoming requirements of various Regulatory Authorities (e.g. China, South Korea, Saudi Arabia) around the world. We are also examining various options to support UDI Track & Trace in the future.