The UDI-DI (Device Identifier) which is the fixed part and the UDI-PI (Production Identifier) which is the dynamic part. On Article 120(12) of MDR 2017/745 it says: “Until the Commission has designated, pursuant to Article 27(2), issuing entities, GS1, HIBCC and ICCBBA shall be considered to be designated issuing entities.”. Or to be more precise, this depends on the classification of your product. And as I am trying to make it easy for you I´ll illustrate this post with multiple examples. Where on software should we write the UDI number? This means it’s not mandatory. The only software that can be commercialized alone is on the scope of Annex 6 Part-C paragraph 6 of the EU MDR. As I see that you are confused, I propose that we look at one example. Packaging levels means the various levels of device packaging that contain a defined quantity of devices, such as a carton or case. On this database you should register your company, and also your products. The concept of UDI-DI, UDI-PI, Basic UDI-DI doesn’t change but the number of letters or numbers is unique to them. It can be a linear bar code as you can see on the example below. Below are some other rules to apply for UDI on a software. Technological and regulatory developments required important updates though. MDR emphasizes patient safety, stipulating greater transparency, traceability and clinical evidence in support of product safety and efficacy claims. On this article I tell you what you need to understand how to implement this new tool. As you may know, software is constantly maintained. This is a product that combines many regulations. On the UDI that is on your product, there are. If you are looking at Annex VI Part C of the MDR 2017/745 and IVDR 2017/746, it will provide you with a general definition of what it is. European Medical Device Directive – Essential Requirements Checklist European Medical Device Directive – Essential requirements checklist Page 1 of 22 And to be honest this is nothing as we just touched the product. So the UDI-carrier is the way you are seeing the UDI code. The EU Medical Devices Regulation does not only cover traditional medical devices but extends to aesthetic devices that present certain characteristics and risk profiles as well i.e. (as it is the weekend – I am sure you will check if this matches lol), We will have 5 pieces with on their label the UDI number: UDI-DI A1 – UDI PI (15/03/2018, Batch number #1,…), 3 pieces with UDI-DI A1 – UDI-PI 1 (with manufacturing date:16/03/2018, Batch number #2,…), 2 pieces with UDI-DI A1 – UDI-PI 2 (with manufacturing date: 19/03/2018, Batch number #3,…), In reality, the companies mentioned are already providing, Health Industry Business Communications Council). In this 28-white paper, Emergo's experts in European regulations discuss what you can expect from the new MDR … As mentioned, this part can vary as it depends on the production characteristic of the product. Serialization of medicines in Russia: Deadline is officially extended! Let me know if this was difficult and if you have done it alone or asked a company to help you. I was initially expecting to issue this topic when there will be more clarity on EUDAMED or the companies that will be allowed to provide the identification numbers. If yes then you understood a good part of what is the UDI for medical devices in Europe. The organization that will provide you the UDI code should also implement a check digit/character. If we create for example many versions of product CO. you´ll need a UDI-DI for each version of your product which will be linked to one Basic UDI-DI. If we create for example many versions of product COa: How many UDI-DI do we need? In the full webinar, we highlight the key parts of the MDR, while going a step further to present a step-by-step MDR … But if you want to include it, knowing that there is no risk to miss the HRI part, you can. If you follow that this will provide you with all the support needed to succeed at attributing a Basic UDI-DI to your products. See the question below. Without that, you cannot use it. The EU MDR now contains 22 (before 18) classification rules, meaning that some devices might change class. This one does not appear on the packaging of the products. And on this group, you have 3 categories of Hip Implants. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU… FDA authorize to have the AIDC or the HRI. (EU MDR), Complete Guide: Medical Device Classification EU MDR (Free PDF), How to build a Medical Device Technical Documentation (MDR 2017/745), How to prepare for a Medical Device Audit? But not so much for me. breast implants, contact lenses, or cosmetic laser equipment and also includes relevant software. No problem. The UDI of the product is composed of the. The following 175 pages were published in the Official Journal of the European Union on 5 May 2017. The UDI, in general, is provided by an official designated entity. There are some rules for where should the UDI be visible. To help you group your products, Medtech Europe created this guideline that contain a Decision Tree. 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