Regulatory Open Forum

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  • 1.  IP Translation

    Posted 28-Feb-2014 13:40
    It's my understanding that IP statements on medical device labeling (e.g., "registered trademark" or "all rights reserved") do not need to be translated for sale in EU, Canada, Mexico or other countries.  

    Is my understanding correct, or do we need to translate these IP terms into all of our IFU languages?

    Can someone provide a reference for the requirement as regards translation of IP statements?

    Thank you.
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    Laura Halper PhD
    Consultant
    Halper Group
    Plano TX
    United States
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  • 2.  RE:IP Translation

    Posted 01-Mar-2014 17:11
    Laura,

    I can not point you to any guidance that I am aware of, but am going to say that the answer is "No" that these notice statements should not be included in the labeling.  The reason is because these notice requirements have nothing to do with the labeling of the device itself.

    First, trademark notice statements are used strictly in intellectual property law as a warning to any potential trademark violators. Trademarks have to be registered and approved in each jurisdiction to be afforded any specific protection by the laws of the country. 
     
    Second, trademark and patent notice statements are limited by jurisdiction.  A trademark or patent filed in the U.S. is not automatically enforceable nor even meaningful outside the U.S. within other countries unless each country has issued a similar trademark or patent under its jurisdiction.  This is normally done via the Madrid - International Trademark System and/or the Patent Cooperation Treaty respectfully.

    Third, Medical Device Regulations are slightly different within each jurisdiction (i.e. U.S., EU, Canada, Japan, etc. ) and depending on how the medical device has been cleared / authorized and distributed / manufactured within each jurisdiction will determine the labeling requirements and the appropriate markings or identification of the Distributor or Manufacturer as part of the labeling requirements.  Therefore, as a result any specific trademark may or may not have any regulatory relevance within or across multiple jurisdictions.



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    Chris Merriam-Leith, MS, RAC, PMP
    Regulatory Project Consultant
    fdaVantage
    Albuquerque NM
    United States
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    Original Message


  • 3.  RE:IP Translation

    Posted 02-Mar-2014 02:32
    As a patent attorney I agree completely with Chris's comments. ------------------------------------------- Janusz Luterek Hahn & Hahn Hatfield South Africa -------------------------------------------
    Original Message


  • 4.  RE:IP Translation

    Posted 04-Mar-2014 09:24
    Thanks to all who have provided their comments.  One further clarification question -- if we have registered a trademark in the EU (the CTM, Community trademark), then do we need to translate the notices into all of the applicable EU languages?

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    Laura Halper PhD
    Consultant
    Halper Group
    Plano TX
    United States
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    Original Message


  • 5.  RE:IP Translation

    Posted 05-Mar-2014 15:17
    Laura,

    Within the context of your clarifications, that your company as within the EU a community registered trademark, then I would point you to the below information regarding the definition of manufacturer.  

    First, you need to make a clear distinction between whether you are talking about labeling requirements, IFU, or packaging requirements.

    Second, you need to make sure you understand the difference between a "Trademark" and a "Trademark Notice"

    Third, you then need to understand how the device will be placed on the Community Market. 

    Then read the below content and hopefully this will help lead you to the correct answer.  It is still my opinion that you do not need to translate any trademark notices as a result of any regulatory requirements under the MDD. But do not confuse the difference between the MDD requirements of trademarks and the purpose of trademark notices.

    Trademarks within the context of the MDD are themselves used to identify the designated "Regulatory defined Manufacturer" within the community, whereas trademark notices may or may not serve this purpose.  

    The question that the EMA may ask is, does providing this IP Notice have the possibility of creating any confusion about who the is the designated community manufacturer, authorized representative, distributor, retailer, wholesaler, sub-contractor, own brand labeller, or private labeller if there are multiple parties or differences.

    Again, "trademark warning notices" are not intended for the user, patient, of consumer.  They are intended as anlegally enforceable offensive IP right to warn potential competitors / violators who may attempt to steal the trademark, or pirate the trademark with the intention of confusing the consumer about the origination / branding or manufacturer of a similar or pirated product.  

    Definition of Manufacturer
    1. The manufacturer is any natural or legal person who is responsible for designing and manufacturing a product with a view to placing it on the Community market "under his own name" (or trademark*).

    2. The responsibilities of the manufacturer apply also to any natural or legal person who assembles, packs, processes, or labels ready-made products with a view to their being placed on the Community market "under his own name".

    3. Further, the responsibility of the manufacturer is placed on any person who changes the intended use of a product in such a way that different essential requirements will become applicable, or substantially modifies or re-builds a product (thus creating a new product), with a view to placing it on the Community market.

    4. The manufacturer may design and manufacture the product himself. As an alternative, he may have it designed, manufactured, assembled, packed, processed or labeled with a view to placing it on the Community market "under his own name", and thus presenting himself as a manufacturer. Where sub-contracting takes place, the manufacturer must retain the overall control for the product and ensure that he receives all the information that is necessary to fulfill his responsibilities according to the New Approach directives. The manufacturer who subcontracts some or all of his activities may in no circumstances discharge himself from his responsibilities, for example to an authorized representative, a distributor, a retailer, a wholesaler, a user or a sub-contractor.

    5. The manufacturer has sole and ultimate responsibility for the conformity of the product to the applicable directives, whether he designed and manufactured the product himself or is considered as a manufacturer because the product is placed on the market "under his name".

    * According to the Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008,
    'manufacturer' shall mean any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product "under his name or trademark."

    Any economic operator that either places a product on the market under his own name or trademark or modifies a product in such a way that compliance with applicable requirements may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.


    Own Brand Labeller
    (also referred to as Private Labeller)
    Own Brand Labeling CE marking


  • An Own Brand Labeller (OBL) purchases a finished (or component parts of a) medical device from the Original Equipment Manufacturer (OEM), which he then places on the market under his own name or trade mark (brand label).

  • This Own Brand Labeller may not be the person who actually designs, manufactures, packages or labels the device.

    • This economic operator, the Own Brand Labeller, meets the definition of manufacturer as set out in the medical devices Directives. Own Brand Labeller or Private Labeller are therefore considered as the legal Manufacturer.


    Obligations of Manufacturers
    1. When placing their products on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements set out in the relevant part of the legislation. 

    2. Manufacturers shall draw up the required technical documentation and carry out the conformity assessment procedure applicable or have it carried out. Where compliance of a product with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EC declaration of conformity and affix the conformity marking. 

    3. Manufacturers shall keep the technical documentation and the EC declaration of conformity for ... [period to be specified in proportion to the lifecycle of the product and the level of risk] after the product has been placed on the market. 

    4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity. Changes in product design or characteristics and changes in the harmonised standards or in technical specifications by reference to which conformity of a product is declared shall be adequately taken into account.

      When deemed appropriate with regard to the risks presented by a product, manufacturers shall, to protect the health and safety of consumers, carry out sample testing of marketed products, investigate, and, if necessary,keep a register of complaints, of non-conforming products and product recalls, and shall keep distributors informed of any such monitoring. 

    5. Manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing theiridentification, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product. 

    6. Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product. The address must indicate a single point at which the manufacturer can be contacted. 

    7. Manufacturers shall ensure that the product is accompanied by instructions and safety information in a languagewhich can be easily understood by consumers and other end-users, as determined by the Member State concerned. 

    8. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the applicable Community harmonisation legislation shall immediately take the necessarycorrective measures to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. 

    9. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market.

    Reference: http://www.ce-marking.com/what-is-a-manufacturer.html


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    Chris Merriam-Leith, MS, RAC, PMP
    Regulatory Project Consultant
    fdaVantage
    Albuquerque NM
    United States
    -------------------------------------------






    Original Message


  • 6.  RE:IP Translation

    Posted 02-Mar-2014 15:16
    Laura,

    My comments are limited in scope to your questions as the legality of "Trademarks" or "Patents", whether it is enforceable or not, falls under each jurisdiction applicable and relevant. 

    Per CE marking language requirements and MDD (in EU as an example), it should be construed that the entire contents of the IFU including "trademark statements," "copyright," or "all rights reserved" is a part of the IFU as the MDD didn't explicitly state as an exception or exempt from the language requirements (national and local language per se).

    However, beneficially speaking, even if it is exempt from the requirements, I would highly recommend you translate into national language at least on the cover page of the IFU for the following reasons.

    As an example, regarding a "Copyright Notice," we frequently use Copyright Symbol like "Copyright (c)* 2014 REGULATORY DOCTOR. All Rights Reserved."

    *: Please consider c is circled in (c). 

    The aforementioned statements constitute or should be interpreted to constitute your proper Notice to the users/patients/stakeholders, etc about your status of Trademark, Patent and/or Copyright (it is even better if a firm has registered or intend to soon register their trademark and copyright in relevant and applicable jurisdictions).  

    If a firm is serious and does choose to do a business seriously, it is highly recommended to choose the good practices including a proper "Notice."   The proper "Notice" can be made much more effective when it is given with a national or local language, later reducing or preventing an innocent defense ("we didn't know ....or we didn't realize it was trademarked or copyrighted in our country or in this region.")

    If you e-mail me at regulatorydoctor @ gmail.com, I can share a couple of IFUs as an example.  

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    Disclaimer - Without Prejudice
    My post above or any other post of mine does not constitute or should not be construed to constitute a legal opinion in any way, shape or form or manner. 

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    President and Principal
    http://www.regulatorydoctor.com
    Riner VA
    United States
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    Original Message