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New Medical Device Symbol?

  • 1.  New Medical Device Symbol?

    Posted 28-Jun-2019 10:32
    ​I understand that this new symbol for a medical device
    thumbnail image
    has been endorsed by ISO TC 210 WG 3 for inclusion in ISO 15223-1.

    Do you believe it is reasonable to go ahead and start using this symbol on your devices or the prudent thing would be to wait?

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    Al Van Houdt RAC
    Sr. Mgr. Regulatory Affairs & Compliance
    Snoqualmie WA
    United States
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  • 2.  RE: New Medical Device Symbol?

    Posted 28-Jun-2019 19:37

    The EU-MDR Annex I 23.2(q) requires, "an indication that the device is a medical device".

    MedTech Europe created a guidance document entitled, "Use of Symbols to Indicate Compliance with the MDR", which includes the suggested symbol. The guidance document says, "The use of symbols on the label as an alternative to written language is permitted in the MDR regulation: Annex 1, chapter III, 23.1. h). Symbols are efficient, cost saving and internationally understood concepts to convey the required information to the user of a medical device."

    The guidance document reminds, "These symbols can be used internationally. They must be described in the Instructions for Use in line with the MDR 23.1. h) until they are published in a harmonized standard."

    It appears, that with the correct documentation, you may use the symbol.



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


  • 3.  RE: New Medical Device Symbol?

    Posted 29-Jun-2019 07:09
    I would wait Al, because there is already a discrepancy between the symbol in the MedTech Europe paper and what may be in ISO 15223-1.  The MedTech has MD in a box, the ISO 15223-1 seems to indicate there is an 'EC' in a box and 'MD' in a box that are together.  ISO 15223-1 is in CD right now, I would wait at least until the DIS is published or more when the FDIS is published (and of course until finally published).

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: New Medical Device Symbol?

    Posted 08-Aug-2019 13:58
    Richard,
    I'm not sure I understand what you mean by "there is an 'EC' in a box and 'MD' in a box that are together." 

    The EC Rep symbol (5.1.2) indicates the authorized representative in the European Community / European Union.  
    The MD symbol (proposed 5.7.7) indicates the item is a medical device.

    These symbols are independent of each other, and there is no additional element connected to the MD symbol.


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    Lena Cordie-Bancroft
    Victoria MN
    United States
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    Original Message


  • 5.  RE: New Medical Device Symbol?

    This message was posted by a user wishing to remain anonymous
    Posted 02-Aug-2019 10:32
    This message was posted by a user wishing to remain anonymous

    It's probably prudent to also recognize that use of the MD symbol in the United States requires that it be published in a harmonized standard - explaining a non-published symbol in the IFU is not an option in the US; you would also have to have adjacent explanatory verbiage on the label. So, if you have the capability for destination-based labeling, then I'd only use the MD symbol on EU product until it is published. If you don't have that capability, don't use the symbol yet.
    Original Message


  • 6.  RE: New Medical Device Symbol?

    Posted 29-Jun-2019 11:24
    If it is a requirement by ISO yes. If it is allowable by ISO  you may want phase it in. If not you will increase cost to packaging and eat out profits for the organization. Plan it with marketing and Inventory and then submit the amendment accordingly.

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    Bosco D'Couto RAC
    Richmond Hill ON
    Canada
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    Original Message


  • 7.  RE: New Medical Device Symbol?

    Posted 30-Jun-2019 03:09
    In the EU Commission request to EU standardization organizations issued on 26 June 2019
    which discusses the proposal for Harmonization of Standards for MDR & IVDR.  In the proposal, there is a request to CEN to update EN ISO 15223-1:2016.   The request states: "Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements" to add in symbols for indicating that a device is a medical device or an in-vitro diagnostic medical device.

    I'm in the process of writing a LinkedIn article on the details of this EU Commission request document. There is a lot of information to digest.

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


  • 8.  RE: New Medical Device Symbol?

    This message was posted by a user wishing to remain anonymous
    Posted 01-Jul-2019 08:11
    This post was removed


  • 9.  RE: New Medical Device Symbol?

    Posted 01-Jul-2019 14:26
    I completely agree Ginger ... like a health care professional would read 3.5 mm craniomaxillofacial plate implant - then their question: is this a medical device?  On the flip-side I can see how there are some combination products or borderline products not readily understandable whether those products are medical devices.  I do see that point.  However, with EUDAMED in the future you can type in the UDI number or product name to understand if this is registered as a medical device.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 10.  RE: New Medical Device Symbol?

    Posted 01-Jul-2019 17:41
    I wonder if the symbol is more for identification in customs than for providers or patients?

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 11.  RE: New Medical Device Symbol?

    Posted 01-Jul-2019 17:48
    ​I don't think Customs will even see the symbol as it will be on the device, not the packaging.

    Perhaps it has to do with the MDR now applies to some non-medical devices like colored contact lens.

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    Al Van Houdt RAC
    Sr. Mgr. Regulatory Affairs & Compliance
    Snoqualmie WA
    United States
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    Original Message


  • 12.  RE: New Medical Device Symbol?

    Posted 02-Jul-2019 08:34
    Dear Al,

    please have in mind:
    SCOPE AND DEFINITIONS Article 1 Subject matter and scope:
    4.For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as 'devices'.

    ANNEX I, GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
    23.2. Information on the label
    (q) an indication that the device is a medical device.

    ANNEX XVI, LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2) 1.

    In consequence that means a product "without an intended medical purpose" will get an "indication that the device is a medical device".

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    Frank Wilmerstaedt
    General Manager QA/RA
    Wentorf bei Hamburg
    Germany
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    Original Message


  • 13.  RE: New Medical Device Symbol?

    Posted 03-Jul-2019 04:50
    Frank, what an interesting observation!
    Articel (2) 'accessory for a medical device' means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device...

    So, those should have the sysmbol as well according to the logic?

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    Ludger Moeller President,
    MDSS GmbH
    lmoeller@mdss.com
    Germany
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    Original Message


  • 14.  RE: New Medical Device Symbol?

    Posted 01-Jul-2019 13:00
    A change in the timing and location of the article I'm working on.  Will hopefully show up in MDO next week on Thursday (11 July) after the 4th of July (US Holiday) weekend.  See my previous post in this discussion for more details.

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


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