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  • 1.  BUDI-DI and DoC

    Posted 05-Jul-2021 09:49
    Dear all,

    we have class IIa medical devices, still with a valid MDD certificate. We issued new DoC to include the provisions that are mandatory under MDR. One thing I cannot understand from the MDR legal text is if the BUDI-DI must be in the Class IIa DoC under MDD, and how this is linked to the EUDAMED provisions, i.e. EUDAMED non mandatory until it is completely working. 

    Thank you

    Chris

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    Christian Micheletti
    Project Manager; Regulatory Affairs expert
    Goldach
    Switzerland
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  • 2.  RE: BUDI-DI and DoC

    Posted 05-Jul-2021 14:05

    There are some related issues so let me address one at a time and then link them.

    First, "EUDAMED non mandatory until it is completely working". Ignore this. In some legal world it is true, but in the practical world it is not. You should populate each module shortly after it comes up. There are two reasons. First, if you save everything for the end, then you will have a large confusing task that you could have easily avoided. Second, your NB will expect you to populate the modules. You should have, by now, obtained your company's SRN and you should be ready to enter the device registration and UDI information in September.

    The Basic UDI-DI has a number of uses, so you should have assigned them. One use is on the EU-MDR DoC. It is not required for the EU-MDD DoC, but if you claim EU-MDR DoC conformity then it must include the Basic UDI-DI [Annex IV(3)].

    Also, under EU-MDR consolidate the DoC to cover all EU legislation that requires a DoC. For example, I have a client that implements MDR, EMC, and RoHS. They have one DoC that covers all three.

    The Basic UDI-DI requirement for the DoC is not related to the Basic UDI-DI requirement in EUDAMED. They are independent uses of the Basic UDI-DI. Another independent example is a Certificate of Free Sale.

    I infer that EU-MDR Article 120 covers the device. By some definitions, it is a legacy device. One use of the Basic UDI-DI is device registration. In this area, MDCG has issued guidance documents related to registration and the Basic UDI-DI for legacy devices.

    MDCG 2021-01 Rev. 1 includes an alternate statement for EU-MDR Art. 26. The alternate includes, "Manufacturers should note that the obligation of UDI assignment (Basic UDI and UDI-DI) to a device applies from 26 May 2021 (Art. 27(3) MDR). Labelling requirements apply gradually, starting from 26 May 2021 (Art. 123(3)(f) MDR)"

    You should also look at MDCG 2018-01 Rev. 4.

    You should also look at MDCG 2019-05 in general and the role of the Eudamed DI and the Eudamed ID for registration of legacy devices. This seems to apply when there is no Basic UDI-DI, but you should have one.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 3.  RE: BUDI-DI and DoC

    Posted 06-Jul-2021 01:45
    Dear both, thank you for your input. I forgot to mention that we are located in Switzerland, so even if I wanted to (and I really wanted), I cannot access EUDAMED. For example, we have no SRN since SwissMedic cannot release it due to forbidden access to EUDAMED Ec. Acto. module. I do not know if the same is going to happen for the rest of EUDAMED, but I fear it will. 
    These things apart, from your answer I get that we need to produce the BUDI-DI ASAP. We already have the UDI for each device, but the general one is missing.
    If I may ask, I am using the EMDN system to group the devices for intended use to derive the BUDI-DI. We have different handpieces that are used in different medical sectors, but at the end they have the same function and same design. If I use the EMDN system, what was before together, now it is not anymore. Is EMDN the main and only nomenclature under MDR even if it is not definitive yet? Can I use a reasoning to group together devices that are exactly the same but have different EMDN nomenclature (e.g. Z120... in common, with last numbers different)?

    Thank you again.

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    Christian Micheletti
    Project Manager; Regulatory Affairs expert
    Goldach
    Switzerland
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    Original Message


  • 4.  RE: BUDI-DI and DoC

    Posted 06-Jul-2021 02:05
    Hi Christian,

    Firstly the Swiss registrations, Switzerland has been added to the countries list that can register in EUDAMED, I just double-checked and it is there just now so you can as a manufacturer register for your SRN. As a third country, you will need an EU Authorised Representative and your competent authority will be based in the same country as your Authorised rep.  Swiss Medic does not issue SRN's, they will validate an application and then EUDAMED generates the SRN, there is no indication as to how long this process will take. Also, I do remember Swiss Medic had published a charge on their site for the validations CHF 200 per hour, I think, and to the best of my knowledge and based on registrations we have completed so far they were the only ones charging. 

    For the EMDN, this is the only nomenclature for EUDAMED. Even if you are registering directive devices you can no longer use the GMDN codes, you must use the EMDN and you can only use the lowest level on the branch. If there are 7 levels then you must pick from the 7th level. You are also allowed to use multiple codes if you have that need.

    The final or first full release of the EMDN codes will be in September and these will cover 2021 and 2022. After which there will be an annual release of the codes, no more bi-monthly releases as with the GMDN this will be far more consistent with fewer more manageable updates. 

    Richard Houlihan
    eudamed.com

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    Richard Houlihan
    Sofia
    Bulgaria
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    Original Message


  • 5.  RE: BUDI-DI and DoC

    Posted 06-Jul-2021 01:32
    Hi All,

    I completely agree with Dan. Leaving EUDAMED to the last minute is not a good idea. Once the devices module goes live in September you have a small chance of getting support from the EUDAMED IT team, this will only be because it will be a new deployment. If you wait until it is legally required in May 2022 then you and the other 80,000 companies will be chasing a very small support team for assistance. 

    There are 3 times the legacy or directive devices must be added to EUDAMED.
    1. If there is a serious vigilance issue, you cannot add data unless the device already exists in EUDAMED.
    2. If it is the first time on the market after EUDAMED is fully functional
    3. By the end of the transition period applicable for device registration, if no equivalent MDR or IVDR device is registered in EUDAMED then you must register the device.

    Not all legacy devices have UDI DI codes and in this case either you manually add the data using the EUDAMED input forms to issue you a device EUDAMED DI & ID code (fake basic udi & udi di) or you issue them yourself using the algorithm the EC provided. We are giving away a free template to do this for you, https://eudamed.com/index.php/eudamed-legacy-device-di-generator/ Note: This generated code is for EUDAMED only not for labelling etc.

    Our strongest advice on EUDAMED is as Dan said, get your device data in as soon as possible. It is your choice for the legacy data but we would recommend adding that too ASAP just in case you have vigilance issues. At the very least collate your data both Regulation and Directive, in spreadsheets so you have it ready and to hand if it is needed quickly. 

    EUDAMED is complicated, preparing your data for it is a small project and can be complicated. If you need assistance or training please do consider us. But do not leave this to the last minute, it really is too big a task to leave to the end.

    Richard Houlihan
    eudamed.com

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    Richard Houlihan
    Sofia
    Bulgaria
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    Original Message


  • 6.  RE: BUDI-DI and DoC

    Posted 06-Jul-2021 04:32
    Edited by Richard Vincins 06-Jul-2021 04:34
    Hello Christian,

    You already have some good advice given.  I just want to make a comment about the Basic Unique Device Identification - Device Identifier or Basic UDI-DI or also called Basic UDI or B-UDI (buddi).  Unfortunately how it is defined in the EU MDR/EU IVDR is not how it is really being used in practice.  (I sighed when reading the MedTech paper https://www.medtecheurope.org/wp-content/uploads/2020/06/200602_MTE-Basic-UDI-DI-guidance-v1.1_final.pdf when it said 'Note: As per the related MDCG 2018-1 v3 guidance document, which provides more clarification to this definition, the Basic UDI-DI is not assigned at the level of unit of use.' which of course contradicts the regulation.  And if you read the guidance, it does not actually say this.  Note: MDCG 2018-1 is at rev 4 now.)

    There is a still a lot of confusion around what is the B-UDI, what is the Basic UDI-DI because different entities like MedTech Europe, EU Commission and Issuing Entities like GS1 throw around terms without being consistent.  There is the terms: group, model, model number, family, model reference, and/or unit level.  This is why I refer to the "top level" device family as the B-UDI and/or the Basic UDI-DI.  And as has been said, the Basic UDI-DI is used in multiple locations including Tech Doc, DofC, SSCP, CFS, etc.
    The EU is making this way more complicated than it needs to be.

    This is a designation you can assign internally within your company, so you do not need to register anywhere for it or request it from any outside entity.  You can assign the B-UDI by product family which indeed can have multiple EMDN numbers.  Depending on the Issuing Entity the B-UDI (or Basic UDI-DI still not completely clear) can generally be up to 13 characters and can be alpha and numeric.  As in GS1 for example, the Global Model Number (GMN) is the company prefix and the Basic UDI-DI with a two digit check.  Honestly it does not matter if you have EU MDD or EU MDR products, the B-UDI can be assigned today, by your own company, and can include on Declaration of Conformity (DofC) as needed.  Just remember the B-UDI is assigned by device or device family, this is the "core" identification which will be used for a device or device family for the EU MDR.  The UDI DI is then all of the individual models or versions underneath a product family which as the guidance says is associated with one (1) Basic UDI-DI.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 7.  RE: BUDI-DI and DoC

    Posted 06-Jul-2021 05:05
    Hi All,

    Three small points.

    1. The Basic UDI must be in the correct format for the selected issuing entity. The EC has designated 4 issuing entities, HIBCC, IFA, GS1, and ICCBBA, the format of the Basic UDI and the UDI DI, and indeed any DI code will be checked against the issuing agency rules for the correct formating.

    2. For regulation devices the Basic UDI can have many UDI DI's as part of the family as long as they meet the product family rules.

    For a directive device as there was never the concept of a Basic UDI you can only have one UDI DI per Basic UDI, and for the Basic UDI in a directive device, EUDAMED is considered to be the issuing entity. Again there are rules here that are checked e.g. for the Basic UDI it must start with B- and the device DI prefixes with D- 
    There is some guidance on legacy device management issued here, https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/legacy_dvc_management_en.pdf and if you need a free generator we have one available for you.

    3. If you already have a UDI DI on your legacy device you can reuse this when you transition to the regulation certification. There is just a small bit of editing needed i.e. B- & D- + actual UDI DI for the legacy device. If you do not have a UDI DI then you can simply use the fake ones you do not need to go to the expense of issuing real ones for legacy devices. See the above guidance.

    Richard Houlihan
    eudamed.com

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    Richard Houlihan
    Sofia
    Bulgaria
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    Original Message


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