Regulatory Open Forum

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  • 1.  System and Procedure packs

    Posted 11-Mar-2022 14:01
    Dear community 

    Could somebody help me with some advice on the following questions:

    When two devices have interaction, combined with no physical interconnection, to achieve a specific medical purpose, e.g. the interaction is given by an RFID signal. Should this be considered as a System per EU MDR regulation definition? 

    One device is a single-use device and several catalogs are available, the other one is a multiuse device, just one catalog that works with all the catalogs of the single-use device. In cases like this, how does the allocation of the UDI work?

    What is expected in terms of traceability for procedure packs and systems?

    @Erik Vollebregt I saw your podcast, very useful,  thank you! I would appreciate you to share your thoughts on this.


    Sr. RA Specialist

  • 2.  RE: System and Procedure packs

    Posted 12-Mar-2022 04:51
    Hi Carolina,

    Physical interaction is not a requirement for a system in the meaning of article 2 (11) MDR ("combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose") - interconnection or combination may take place wirelessly just as well.

    UDI details for systems are in Annex VI, part C, 6.3 (which even refers to the case of SUDs in a system as in your example).

    For traceability there are the (Eudamed) registration requirements for the system (see the Eudamed guidance documents for guidance), and the supply chain controls under articles 13 (importer) and 14 (distributor) for the respective devices in the system.

    Erik Vollebregt

  • 3.  RE: System and Procedure packs

    Posted 13-Mar-2022 13:49
    Hello Carolina,

    Something also to consider is if the devices are under your company control, e.g. both devices are made by the same company, this can certainly be defined by the organisation as a "system" or as connected devices.  Meaning the company can support the RFID interaction is either they need to work together, a system, or can work together so could be regulated separately.  Therefore, looking from a Basic UDI-DI perspective determining whether they would be under the same Technical Documentation or separate Technical Documentation.  If the devices are made by two different companies, then would definitely look at them separately and so they would just be "interconnected" and not a system.  Also note, as you are probably aware, there are GSPR requirements for connectivity of devices ensuring safety and performance are maintained according to the intended use and intended purpose.

    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs

  • 4.  RE: System and Procedure packs

    Posted 15-Mar-2022 08:14

    Hello Carolina, 

    with respect to your question about "systems and procedure packs (MDR Art. 22)". 
    >> I assume, that your company is the manufacturer for both products. In this case, I conclude that MDR Art. does not apply, based on the first sentence in Art. 22: 

    "Natural or legal persons shall draw up a statement if they combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack."


    The two devices work together at the users side and a system per MDR definition 11. Nevertheless,  no natural or legal person (other than the manufacture itself) combines products for placing on the market. 

    Uwe Zeller | Regulatory Affairs / Risk Management Consultant
    Biberach an der Riß, Germany

  • 5.  RE: System and Procedure packs

    Posted 17-Mar-2022 02:44

    Dear Carolina,

    related to your question if devices that interact with each other without physical connection to achieve a specific medical purpose are to be classified as a system according to MDR Article 2 (11). If so, a system UDI is necessary.

    BUT: If the devices interact with each other, e.g. via an RFID signal, but do not achieve a specific medical purpose in their combination (each device continues to act in its own medical purpose), they are not a system according to MDR. Then no system UDI is necessary.

    As Erik Vollebregt already described, details on how to allocate a system UDI can be found in MDR, Annex VI, Part C, 6.3.

    Best regards

    Carolin Bombeck

  • 6.  RE: System and Procedure packs

    Posted 17-Mar-2022 09:44

    Thank you @Erik Vollebregt, @Richard Vincins, @Carolin Bombek, @Uwe Zeller for your replies, your comments are very useful. We had already reviewed the requirements and guidance, however, some holes need to be clarified. It seems that there are still things subject to interpretation.


    Sr. RA Specialist