Best Practices for UDI Implementation and EUDAMED Submissions – Q&A
Celegence, a Global Regulatory Affairs Services & Technology company for the Life Sciences Industry, partnered with Q1 Productions in January 2021 to offer a webcast titled “Best Practices for UDI Implementation and EUDAMED Submissions.”
By replaying this webinar, you will have an opportunity to develop a comprehensive, and advanced understanding of the best practices for registering medical devices in all risk classes and learn about the challenges of UDI implementation that medical device manufacturers face.
Additionally, you will understand the best practices for creating structured device registration and Unique Device Identification (UDI) data, as well as for implementing EU MDR compliant product labels to comply with the date of application (DoA) requirements.
If you were not able to attend this webinar, here’s a link where you can view the on-demand version. We are here to help address any other questions that you may have related to the webinar, or questions about how you may be able to benefit from our MDR compliance services or technology, we are happy to assist. Contact us to find out how we can help you optimize your RA/QA strategy.
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Q: Which products are subject to the UDI system?
A– Sharma: In terms of exemptions, any of the custom designed devices, or any of investigational devices are exempt. But all medical devices, including in vitro diagnostic devices, have to be compliant to the UDI requirements. If any of the Article 18 implant cards come into play, there are in terms of exemptions, like the sutures and others, but they need to be compliant to the UDI system.
Q: Who is responsible for placing the UDI carrier on the device itself on the label and on the package of the device?
A- Sharma: This is the responsibility of all of the people who have helped place the product on the market, in other words, the economic operators. They will be labelers or developers in accordance with US requirements, and at the same time as the EU MDR requirements, they may be a manufacturer, distributor, or importer. If you go back to Articles 10, 13, and 12 you will come across the responsibilities of the individual parties in the supply chain. It is not just on the manufacturer, each of the parties have their own responsibility.
Q: What are the UDI and device data sets to be provided in EUDAMED?
A-John: The best way I can address it is to say that at this early juncture, the UDI module is not yet available and it is slated for availability in May of 2021. So it would be trying to read the future to give you real guidance, but you know, this is an area where we will be paying close attention when they update this information in the coming months.
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Q: What happens in the case of article 16 of the MDR and IVDR?
A-Sharma: In terms of the obligations of the manufacturer, the importers, distributors, and other persons, it means that you must have the pre-market requirements of declaring the product’s UDIs, which can be traced through production and to the post-market and product launch.
In terms of the product service from Article 16, it explicitly mentions the registered trademarks. As a distributor or importer who is placing the product into the market, you must be compliant to all of the requirements that have been listed for the product compliance in ANNEX 2 and ANNEX 3, which also include the unique device identification.
Q: What obligations do economic operators have regarding UDI when assuming obligation incumbent on manufacturers per Article 16 of MDR and IVDR?
A-Sharma: In one of the ratified texts of Article 16, it mentions that a distributor, importer, or other legal person shall assume the obligations incumbent on manufacturers.
If it is a product that is a part of a procedure pack or a sterile pack, the procedure pack or sterile pack will become a standalone device. So that product, no matter how many devices it has inside, which may be supplied by the manufacturer, or being supplied by the suppliers, it will be a part of the product technical information. So if you have a procedure pack, containing different individual devices, that will be part of the product technical information, but the UDI will be for the entire procedure pack.
Q: What is the procedure for systems and procedure packs to undergo a UDI registration?
A-Sharma: In Article 22, for the systems and the procedure packs, we can see that any of the products or sterilization trays, or a bunch of CE marked or non-CE marked products, which have been kept as a pack, will be considered as a standalone device itself and will have its own UDI.
But when we are opening the pack and trying to see what the UDI code is for the individual products it does not apply. So, this is where we have been discussing the complications that arise in those kinds of areas, like software as a medical device, the procedure packs or sterile packs have not been fully clarified by MDCG 2018 – 5 for their UDI requirements or guidance.
Q: Are devices which are compliant with the MDD and are placed on the market after the date of application, are they still subject to UDI requirements?
A-Sharma: I would say yes. The date of application of 26th of May 2021 is the deadline to comply with all the articles of the EU MDR, or the 26th of May 2022 for the IVDR.
This includes Annex 1 of the GSPR – the general safety performance requirements and Annex 2, including the UDI requirements and the product registrations, you should be getting ready for the date of application. For the legacy products, which have not given any kind of a UDI code or number in terms of their UDI device identification, they will not be considered compliant past 26th May 2021.
