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  • 1.  MDR Deficiency Article 22 -Procedure packs

    This message was posted by a user wishing to remain anonymous
    Posted 13-May-2024 09:14
    This message was posted by a user wishing to remain anonymous

    Hi,

    We have received a query for our Class IIb Ophthalmic laser device which uses a powered table for raising and lowering the device (connected to the console). We also supply ophthalmic lenses ( third party manufactured) with the parent device. For our MDR submission , we had declared the table (class I)and lenses as accessories (Class I and Is) . However, the reviewer wants us to show compliance to Article 22 with respect to procedure packs and provide a declaration. Isnt there an exemption for supplied accessories under the    MDCG 2018-3 for Procedure Packs?  And we are wondering whether the powered table can actually be called an accessory  as it is not directly supporting the intended use of the device? And the lenses are also included under Annex XVI Devices without a medical purpose. I am confused, what is the best way to answer this deficiency?



  • 2.  RE: MDR Deficiency Article 22 -Procedure packs

    Posted 13-May-2024 16:17

    The exemption cited in MDCG 2018-3 is for distributors and importers and not applicable to legal manufacturers. It is intended for ease of shipment in supply chain. Based on your description, it seems like the NB considers your device as a system and therefore has asked for compliance to Article 22.  Article 22 applies to both Systems and Procedure Packs. Although, the MDR regulation for system and procedure pack are same there are differences in how they are defined. 'System' means a combination of products, either packaged together or not, which are intended to be inter- connected or combined to achieve a specific medical purpose. Creating a system file to address Article 22.2 (a), (b) and (c) is what the reviewer is likely expecting. The system file is a much easier document to generate compared to STED file. 



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    Samhitha Mohan
    BD - ENTERPRISE
    Lake Stevens WA
    United States
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  • 3.  RE: MDR Deficiency Article 22 -Procedure packs

    Posted 14-May-2024 03:55

    Anon,

    It depends if the powered table and ophthalmic lenses are being labeled under your company name as the "legal" Manufacturer or not.  Also is the powered table and ophthalmic lenses actual medical devices or they being classified as "accessories" because how it may fit into the overall device?  There is a lot of bad interpretation made by Notified Body reviewers for Article 22, so it needs to be clear how those parts or products align, used with, interoperate with, your device to clearly define whether they would be accessories or potentially under Article 22.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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  • 4.  RE: MDR Deficiency Article 22 -Procedure packs

    This message was posted by a user wishing to remain anonymous
    Posted 15-May-2024 09:07
    This message was posted by a user wishing to remain anonymous

    Hi Richard ,

    Thanks for your response , yes all of them are accessories. Could you clarify "so it needs to be clear how those parts or products align, used with, interoperate with, your device to clearly define whether they would be accessories or potentially under Article 22 "?




  • 5.  RE: MDR Deficiency Article 22 -Procedure packs

    This message was posted by a user wishing to remain anonymous
    Posted 14-May-2024 09:00
    This message was posted by a user wishing to remain anonymous

    Thanks Samhitha.

    The table and safety glasses have to be used with the device but the rest are optional and we are only supplying them with our device , these can be directly bought from the manufacturers.




  • 6.  RE: MDR Deficiency Article 22 -Procedure packs

    Posted 17-May-2024 07:22

    Hi Anon,

    systems/procedure packs and Article 22 can be a little bit tricky (and for some reason NBs love to comment on them although in my opinion it is not their primary concern) so could you share some additional information:

    Could you share the exact wording of the noncompliance (if there was one)?

    How are device and accessories sold? Is there one sales packaging with its own article number that includes laser, table and lenses (and maybe additional accessories)? Or are they offered separately, each with its own article number and just packaged together in a logistics package?

    If you are the manufacturer of the laser and the table: Do you consider them to be separate devices that are then combined or do you consider this as a system/procedure pack that is a device in itself (in the latter case with one common Technical Documentation)?

    Best regards, Christoph



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    Christoph Kiesselbach
    Schrack & Partner
    Reutlingen
    Germany
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