device and if that is not possible it shall be placed on the packaging

so i am pontus yada i have worked as the technical planning manager for an mdr notified body for several years and this video is part of my course introduction to mdr the medicaid device regulation and are you interested in the full course on the mdr check out the course by visiting the course page that is linked below and if you need a record of your training in this area the full course will result in you receiving a course certificate before we start ensure that you are subscribed to our channel to make sure you're always on top of content then click the notification button too let's dig right into it now let's look at the requirements related to the unique device identifier or just short udi udi is applicable to all manufacturer of medica devices in europe and before we dig into the udi requirements in europe i would just like to clarify once and for all that the udi requirements in europe are not identical to the udi requirements of other markets like the u.s market a colleague of mine once said during a training session we had on medicare devices that should be a slogan for udi i think okay i said and what would that be he answered udi more than just the barcode and i actually have to admit that he was quite right at the time it is a lot more than just the barcode even though i never heard this slogan again after that meeting sorry i know it's a bit nerdy but what more can we do to bring more attention to this important subject but jokes aside this udi thingy is actually a whole world of its own so let's start to introduce you to this world let's start with an overview of the udi concept we can picture it as three pillars starting from the left and i will then further elaborate the pillars first we have the basic udidi or sometimes called beauty the purpose of the basic udidi is to act as the main key in udemy and relevant documentation like certificates declaration of conformity technical documentation periodic safety update reports and sscps but also certificates of free sales worth noting for those of you taking this course outside europe is that the basic udidi is unique to the european union and therefore there is no corresponding codes available in for example us which has already and will probably continue to cause some confusion the basic udidi is kind of a collective code used to cover devices with the same intended purpose risk class and essential design and manufacturing characteristics the basic udidi shall not be on any device or packaging it is only to be used as a collective term for grouping devices and for reporting into udemed moving down in this blue pillar now one basic udidi can then cover several udis as i just explained but a udi cannot be included in several basic udidis the actual udi is then split into two parts the udidi and the udi pi di stands for device identifier and pi stands for production identifier the udi part is mandatory for all medicaid devices whereas the udi pi part is only applicable where production related information is required to be included in the labeling like lot number serial number software release or when expiry date is essential to communicate so please understand that if expiry date or manufacturing date is essential for your device independent on class a udi pi is required so basically we can say that any essential information on the label that is defined during the production will require a udi pi the udi shall be placed on the product by the manufacturer and no one else and thereby it is also a requirement that the manufacturer has integrated the assignment and application of the udi in their qms below this video you'll find an mdcg endos document explaining the udi requirements in relation to the manufacturer's qms it is really quite a good guidance so i recommend you to read it and i expect or actually i know that notified bodies will follow this guideline both the beauties and the duties shall be unique to the manufacturer and must be obtained from a designated issuing entity in accordance to that issuing entities nomenclature there is a list of currently available issuing entities below this video the basic udidi is an alphanumeric code that shall be readable for humans a human readable interface or short hri so no need for barcodes on the basic udidi but the udi including then the udidi and pi shall both be readable to humans and to machines and machine readable interface is abbreviated aidc which stands for automatic identification and data capture examples of aidcs are 2d barcodes dot matric codes biometric codes or rfid as i just mentioned the basic udidi is for example used for certificate but also needed when registering the actual device in udemad together with the udidi and those two are the so-called static parts of the udi system meaning as long as you don't change your device or add or remove devices they remain the same there is an mdcg endorsed document mdcg 2018-1 published that explains when you need to change gud idi and also the relationship to the basic udidi for those you find the link under the video focusing on the udi di a bit then the udidi must be unique to a manufacturer and a device and it shall be both human and machine readable so to put it in normal words the ud idi is kind of corresponding to the order number that you will use for selling your devices this is also known as the ref number but please note that this doesn't mean that you need to replace your order number ref number with the actual udidi code but they must be linked internally and also in udemed this also means if you offer your product in different quantities for example a five pack of a product or a twenty pack and they have different order numbers you need to have different udi idis for those levels of packaging meaning one ud idi for the actual device and another udidi for the sales package if so if in anything else than a single pack but please note that shipping containers are excluded from the udi requirements that was a summary of the udi setup now let's continue with the udi carrier which is basically the label then first of all let's just make it clear again the udi carrier shall not include the basic udidi only the udidi and if applicable to udi pi and once again the udai carrier shall be readable both to humans and machines the udi shall be placed on the actual let'sdevice and if that is not possible it shall be placed on the packaging

then focus a bit on the udi pi part the pi production identifier part of the udi code is the code that is dynamic and used to identify the specific data related to the production of that specific device such as serial number lot number software identification manufacturing or expiry date or both of those dates and for devices exclusively intended for retail sales for example band aids the udi pi is not required to appear on the sales packaging as aidc meaning machine readable so that is excluded for those retail devices and at the other end of the risk scale there are active implantable medical devices and for them the serial number on unit level is mandatory to be included in the udi pi so what could one of those machine readable codes look like well here is an example of a 2d barcode udi including the udidi and the udi pi and as you hopefully understand if the pi part needs more data then we need a longer code and if your product doesn't have a really big label it could become a challenge to fit this barcode onto the existing one but there are dot matrix codes available to use also if a 2d barcode will be too long but still the data must be able to be read by humans also so when do you need to comply with this marking of the udi on your device here you see the dates when the udi carrier must be on your device the upper row is for normal devices and the bottom row is for devices that are intended to be reduced like surgical instruments and the dates for those reusable devices shown here is the date when the actual device needs to be the udi carrier themselves so basically meaning marking the device itself with the full udi not just on the label as you can see now udi is more than just a barcode so the majority of the mdr requirements are collected in article 27 and annex 6 but i have to admit that this annex is quite messy and not the best part of the mdr actually and since there are quite many things in the mdr that needs to be clarified in relation to udi the mdcg has been busy in issuing guidance documents on this subject so i strongly recommend you to frequently check the mdcg web to see if when new or updated guidelines are published related to udi and be aware that there are some specific requirements for software and procedure packs plus some other devices that have specific guidelines published by the mdcg for the udi feel free to drop a comment or question below i'd love to talk to you are you on linkedin make sure you follow medicaldevicehq there and do tell our friends from the medical device industry to connect with us too that's all for now thanks for watching once again and see you next time