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  • 1.  CE Marking

    Posted 20-May-2015 16:21
    Can anyone refer me to the procedures for filing for a CE mark for a pulse oximeter?  I understand a Product Definition File and Risk Analysis are required.  Thank you.   

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    David Lucking
     FL
    United States
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  • 2.  RE: CE Marking

    Posted 22-May-2015 03:29
    Hi David,

    Have you classified your device in accordance with Article 9 & Annex IX of the MDD?  If so, and the device is anything other than a class I non-sterile/non-measuring (I suspect your device might be IIa), a Notified Body will be involved in your conformity assessment.  You need to determine a conformity assessment procedure (CAP) suitable for the class of you device and prepare all of the technical documentation associated with that CAP, Put this all together in your technical file and have your CAP assessed by a Notified body.  They will then issue you with the appropriate certificate, you can sign your manufacturer's declaration of conformity and apply the CE mark with NB number to your device.

    Note: In addition to the requirement of your chosen CAP, you will need to demonstrate (as with all devices) that it conforms with the Essential Requirements of Annex II.  This will be included in your tech file including all the supporting information.

    If you require any further information, please don't hesitate in getting in touch.

    Good luck!!

    Seamus

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    Seamus Kearney
    Principal Consultant & Managing Director
    Advance Regulatory Consulting Limited
    Magherafelt
    United Kingdom
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    Original Message


  • 3.  RE: CE Marking

    Posted 22-May-2015 04:45

    Also keep in mind that you need an Authorised rep based in EU.

    thanks
    Marianna
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    Marianna Hofer Orfanidou
    Sn Regulatory Affairs Manager
    Nobel Biocare
    Kloten
    Switzerland
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    Original Message


  • 4.  RE: CE Marking

    Posted 22-May-2015 08:25
    As for a "Pulse Oximeter,"  it is an active device per MEDDEV at http://regulatorydoctor.com/eu-ce-mark-consulting-ce-marking-consultant/eu-medical-device-classification-meddev-guidance/.

    Thus, medical device classification rules 9-12 apply.

    In particular, Rule 10 applies.

    Rule 10 states "Active device for diagnosis, if intended to supply energy....or for direct diagnosis or monitoring of vital physiological process" as IIa.

    HOWEVER

    As the pulse oximeter is specifically intended to "monitor vital physiological parameters where variations could result in immediate danger,"  it really falls under IIb.

    As for choosing conformity assessment routes, options applicable for IIb include "Annexes II (without section 4), III, IV, V and VI.

    To help you better understand conformity assessment options available, you may look at the conformity assessment flowchart at https://www.globalcomplianceseminar.com/?attachment_id=6261

    FYI: here is my CE mark training online seminar at https://www.globalcomplianceseminar.com/event/live-seminar-ce-mark-content-format-technical-file-design-dossier/

    I would recommend you please consider developing a robust regulatory plan moving forward so that you can save your significant amount of time, efforts and resources.

    FYI: here is my training for the topic at https://www.globalcomplianceseminar.com/event/live-seminar-developing-implementing-global-regulatory-plan-strategy/

    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR
    Phone (Toll-Free): 1-(800) 321-8567
    E-mail:  David@RegulatoryDoctor.com


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  • 5.  RE: CE Marking

    Posted 23-May-2015 02:22
    David, the EU regulatory scheme for medical devices is a good bit different from FDA's.   You don't "file" for a CE Mark the way you file for FDA clearance or approval.

    The UK's regulatory authority has a high-level overview of the EU approach, with links to other sources for more detailed information:

    https://www.gov.uk/medical-devices-conformity-assessment-and-the-ce-mark


    Julie Omohundro RAC
    Durham NC
    United States
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    Original Message


  • 6.  RE:CE Marking

    Posted 24-May-2015 08:09
    Well, for higher risk devices IIb and III you do file for the CE mark by submitting a design dossier to the Notified Body.

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    Ginger Cantor RAC
    Centaur Consulting LLC, Owner and Principal Consultant
    River Falls WI
    United States
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  • 7.  RE:CE Marking

    Posted 25-May-2015 03:28
    Firstly, dossier review and issuance of a design examination certificate by a Notified Body is for class III devices only. For class IIB and below that 'dossier' is called a tech file, and the NB only examines a representative sample of tech files among the devices you have already placed on the market.

    Secondly, the expression 'file for a CE mark' is technically incorrect because no-one grants you the right to affix the CE mark to your device. You can do it at any time, and by placing the device on the market with a CE mark affixed, you are stating to the world that the device complies with all applicable European Union harmonisation legislation. This statement is elaborated in further detail via the Declaration(s) of Conformity.

    You absolutely must comply with legislative obligations before it becomes LAWFUL to affix the CE mark and then market your device, but no-one grants you the CE mark. For devices requiring NB intervention, what you're technically 'filing' for is an EC certificate and, for Class III devices, a design examination certificate.

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    Oliver Bisazza
    Associate Director, Regulatory Policy, EMEA
    Mechelen
    Belgium
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  • 8.  RE: CE Marking

    Posted 25-May-2015 11:36
    Oliver, for those in the US who are very familiar with the FDA process but new to CE Marking, the EU process with Class III devices feels more like "home," so there I would not quibble too much with "file for a CE Mark."  You send a bunch of paper to someone, they review it, and you can't market your device until they give you the green light.  When someone in the US talks about "filing," that is essentially the process they are referring to. 

    That is not what happens with lower risk devices, which in US are most likely to be "cleared" via the 510(k) process.  There, I think it is confusing for someone in the US to go into the EU process expecting a "filing" process, because they are not going to find anything like the process that they think of as "filing."

    I do, however, constantly quibble with "technical file," although I think it's probably a lost cause.  If the term is used anywhere in MDD 93/42/EEC, I've never been able to find it.  Moreover, the Rationale and History Sheet in NB-MED 2.5.1 reports that, at their November 1999 meeting, NB-MED decided not to use this term because "    not a technical file but a system/organisation of technical documentation is required."


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    Julie Omohundro RAC
    Durham NC
    United States


    Original Message