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CE-mark and Classification

  • 1.  CE-mark and Classification

    This message was posted by a user wishing to remain anonymous
    Posted 17-Jan-2019 09:21
    This message was posted by a user wishing to remain anonymous

    Hi everyone,

    Does EU have a database similar to FDA's product classification database where if you type in the name of the device, you will get the classification as well?  If we know a product is CE-marked, is there a way to find out what its classification is?

    Thank you.


  • 2.  RE: CE-mark and Classification

    Posted 18-Jan-2019 04:20
    Hi Anon,

    Such database does not exist in Europe.
    We hope Eudamed will assist with this issue. We have to wait and see the format and which information will finally be available to the public.

    Hope that helps

    ------------------------------
    Spyros Drivelos
    Medical Devices Manager
    Agia Paraskevi, Athens
    Greece
    ------------------------------



  • 3.  RE: CE-mark and Classification

    Posted 18-Jan-2019 05:00
    The way I have done it in the past was to take a look at the CE mark on the packaging / IFU and if it has a NB number then you can google which NB it is and then you can search on their site. If there isn't a NB number then we assumed it was Class I.

    ------------------------------
    Helen
    Cambridge
    United Kingdom
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  • 4.  RE: CE-mark and Classification

    Posted 18-Jan-2019 05:54
    ​There is no EU database re: classification as FDA. Each medical device for EU must be classified in accordance with the rules defined in 93/42/EEC Medical Device Directive (MDD) Annex IX and from the MDD replacement  2017/745 EC Medical Device Regulation (MDR) ANNEX VIII.
    Trust this helps

    ------------------------------
    George Buchan BA (Hons), MBA
    Managing Director
    G.P.B. Limited
    Prestwick, S. Ayrshire
    Scotland
    ------------------------------



  • 5.  RE: CE-mark and Classification

    Posted 19-Jan-2019 02:54
    As everyone has responded there is no current database but there is an existing guidance document for the MDD classifications issued June of 2010 Guidance document - Classification of Medical Devices - MEDDEV 2.4/1 rev.9

    ------------------------------
    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
    ------------------------------



  • 6.  RE: CE-mark and Classification

    Posted 20-Jan-2019 03:52
      |   view attached
    Hi
    there is a MEDDEV which can help you to orient in the EU classification see atached MEDDEV

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    Evangelos Tavandzis
    Praha
    Czech Republic
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    Attachment(s)



  • 7.  RE: CE-mark and Classification

    Posted 20-Jan-2019 20:48
    Or you can go to the Directive or Regulation directly based on the Rule determines classification of the device ... however some do not always apply the correct classification and Rule.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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  • 8.  RE: CE-mark and Classification

    Posted 21-Jan-2019 09:35
    Hello, 
    There is MEDDEV 2. 4/1 Rev. 9 on Classification of medical devices and
    MEDDEV 2.1/6 on Standalone software…
    Best regards,
    Stefan

    ------------------------------
    Dr. Stefan Menzl
    Geschäftsführer / Executive Director
    Qserve Group Deutschland GmbH
    +49 152 900 28156
    stefan.menzl@qservegroup.com
    ------------------------------



  • 9.  RE: CE-mark and Classification

    Posted 21-Jan-2019 02:01
    As already mentioned, the new EUDAMED will become the EU database which will contain information about 
    - type of devices on the EU market (UDI-DI)
    - Economic Operators (manufacturer, EU representative, importer)
    - Certificates
    - Vigilance reporting
    - Application to initiate clinical trials
    - Market surveillance (authority use)
    Some of this information will be publicly available.

    But despite this database becoming active some time from now, it will still not offer the feature to provide the specific classification of a specific device. To identify the classification, one has to apply the classification rules (per MDD, Annex IX,  or in the future MDR, Annex VIII).
    If a device does not have a Notified Body number next to the CE mark on the labelling this is a hint that the device is a class I device (no measuring function, non-sterile, not reusable (MDR)).

    Best regards,
    Stefan

    ------------------------------
    Dr. Stefan Menzl
    Geschäftsführer / Executive Director
    Qserve Group Deutschland GmbH
    +49 152 900 28156
    stefan.menzl@qservegroup.com
    ------------------------------



  • 10.  RE: CE-mark and Classification

    Posted 22-Jan-2019 02:49
    Good morning

    While such a database doesn't exist (as many of the responders already mentioned), there is a neat work-around IF the device in question is also sold in Australia. TGA has a public database which can be searched and offers a public summary of the device which includes its classification:  https://www.tga.gov.au/searching-australian-register-therapeutic-goods-artg

    Since the classification is the same in Australia and Europe (for most but not all devices!), this may give you the information you look for. BTW: it's also very helpful if you search for specific GMDN codes...

    Cheers from Switzerland
    Beat

    ------------------------------
    Beat U. Steffen
    confinis ag
    Founder & CEO
    Sursee
    Switzerland
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  • 11.  RE: CE-mark and Classification

    Posted 23-Jan-2019 07:49
    Hello Beat

    Besides using the MDD rules, I also used the TGA database as a "check". We think alike there!

    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------



  • 12.  RE: CE-mark and Classification

    Posted 23-Jan-2019 08:16
    The main problem is that in some cases, a product can have a different classification depending on the Notified Body.
    There are numerous, exactly the same products, across Europe with different classification.
    The most common products are those with low-risk classification.
    You can see a product in Italy classified as Class I and in France it is Class IIa.

    So, at the end of the day, you cannot be sure of the actual classification of a product.

    ------------------------------
    Spyros Drivelos
    Medical Devices Manager
    Agia Paraskevi, Athens
    Greece
    ------------------------------