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  • 1.  Registering of medical devices without having the CE mark

    This message was posted by a user wishing to remain anonymous
    Posted 09-Jan-2024 08:28
    This message was posted by a user wishing to remain anonymous

    Dear all,

    Can anyone tell me in which countries you are able to register your medical device without having the European CE mark on your product? 
    Is there somewhere a list which is publicly available? 

    Thank you.



  • 2.  RE: Registering of medical devices without having the CE mark

    Posted 10-Jan-2024 02:43

    Hello Anon,

    The only place where a CE Mark is required is the European Union.  The CE Mark is not required for registration or means of approval in other countries - however there are countries where this facilitates, speeds up, or allows easier access to selling the device in that country.  Australia as an example is a country where if the product is already CE Marked allows a much quicker ability to get on the market.  I doubt you will find a list of countries where registering a medical device without CE mark exists, because each country has their own regulations and requirements.  In addition, you would have to look at each country individually depending on your market needs, though there might be regulatory intelligence companies which offer this as a paid service.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    Oriel STAT A MATRIX - ENTERPRISE
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    Original Message


  • 3.  RE: Registering of medical devices without having the CE mark

    This message was posted by a user wishing to remain anonymous
    Posted 10-Jan-2024 09:00
    This message was posted by a user wishing to remain anonymous

    There are very few countries outside the Union that require Union regulations, though there are several that give credit for it.


    Original Message


  • 4.  RE: Registering of medical devices without having the CE mark

    Posted 10-Jan-2024 11:41

    As far as I'm aware, all save EU27, Turkey, and Switzerland.



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    Corey Jaseph RAC
    Senior Research Analyst
    politico
    Morongo Valley CA
    United States
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    Original Message


  • 5.  RE: Registering of medical devices without having the CE mark

    Posted 10-Jan-2024 14:32

    My understanding is that the only countries who demand the CE mark are those in Europe's "Union" market. Thus, all others don't.  Note that Europe's Union market is not the same as (yet includes) the European Union (EU).  Specifically, at last check, Europe's Union market currently includes the European Union (i.e., its 27 member states), plus the EEA EFTA states (Iceland, Liechtenstein and Norway) plus any other countries with a mutual recognition agreement (MRA) in place.  Currently, that MRA route consists of Turkey.  In addition, Northern Ireland under the Northern Ireland Protocol (not officially an MRA as I understand it) also requires the CE mark.

    Thus, marketing outside these aforesaid countries does not require a CE mark.  A few comments about Switzerland follows, as it could be confused that the CE mark is required for Swiss marketing when in fact it isn't always.

    Switzerland doesn't require a CE mark, yet there are some tricky variables.  Specifically, Switzerland offers streamlined SwissMedic premarket authorization if the device officially meets Europe's CE marking requirements and bears a corresponding rightly affixed CE marking (meaning that it went through formal Union MDR conformity assessment and declaration for purposes of marketing in Europe's Union and application of a CE mark for the Union jurisdiction).  Alternatively, if the subject device didn't actually go through formal Union MDR conformity assessment and declaration for marketing in Europe's Union and application of a CE mark for the Union jurisdiction, then SwissMedic doesn't require the CE mark on the label (in fact, such a requirement would constitute a wrongly affixed CE mark in contravention of European law/legislation).  Yet via incorporation by reference into its MedDO, SwissMedic does require characteristic conformity with certain parts of Europe's MDR.  But again, that is not necessarily for affixing a CE mark.  Instead, when such conformity by reference is established apart from an official EU MDR conformity assessment for Union marketing, then the label shall bear Switzerland's special alternative mark rather than a CE mark.  Thus, Switzerland doesn't require a CE mark in that case.



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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


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