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  • 1.  MDR and EU Harmonized Standards

    This message was posted by a user wishing to remain anonymous
    Posted 30-Jan-2019 08:43
    This message was posted by a user wishing to remain anonymous

    I am a little confused on this issue.....
    In preparation for CE marking per the MDR, how are manufacturers supposed to be able to declare conformity with harmonized standards if those standards do not currently reflect the requirements of the MDR? Is there a timetable for those standards to be updated? How will that be done on time?

    Thanks


  • 2.  RE: MDR and EU Harmonized Standards

    Posted 31-Jan-2019 04:46
    You have asked a million dollar question.  It is one of the work task items, but I highly doubt the harmonised list will get updated before MDR or even shortly after.  My recommendation to companies is within your Technical Documentation index or referenced document create your own list of harmonised standards that you are applying to your device, including any version or year published.  Also rather then just have a list of harmonised standards, include a brief description of how this is being applied to your organisation and/or products.  This is especially true if you are following a more recent standard, i.e. ISO 10993-1:2018 should have a reference or documentation for how you have assessed this for impact on the product safety and performance.  I would still declare conformity to any applicable Directives, Regulations, or harmonised standards, either on your Declaration of Conformity (as appropriate) and technical documentation with the brief description.  Unfortunately the harmonised list even under the MDD was never maintained sufficiently, so make sure you have this all documented internal to your company.  Notified Bodies also expect a list a harmonised standards that are applied, including the version or date of publication - use a EN or EN/BS version as applicable.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: MDR and EU Harmonized Standards

    Posted 31-Jan-2019 06:53
    Good questions my anonymous friend!

    The Medical Device Regulation identifies some 100+ potential pieces of supporting EU legislation in the form of implementing and delegated acts.
    In addition to these, the Commission has told us the current MEDDEV guidances will need to be replaced (the original intention was that most/all of these would not be needed due to the expanded legal text).
    CAMD and other groupings are also working on, or have set up committees to work on, numerous other Documents, NBOGs etc
    All the currently harmonized standards will need updating, the Annex Zs will need to reference MDR GSPRs instead of MDD ERs - and as you rightly point out, many will require many new clauses to address new requirements in the MDR.
    And then of course there all the instructions etc around the EUDAMED super-national IT project.

    Will all this be ready by 2020? - No chance imho!
    Will the MDR implementation be postponed? - Equally no chance imho!

    So what to do ... as the Devices Head at one NB told me: "... just work to the old documents until the new ones are published." So I am affraid you are trying to hit a moving target for the next few years. What frightens me more is that there will a flurry of documents published early 2020 into the run up to MDR and manufacturers will need to be constant updates to their technical documentation to address these at the same time as getting MDR products on the market.

    Sorry its bad news, but on the bright side, that will certainly give me  job security for the rest of my working life!

    Neil

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    Neil Armstrong FRAPS
    CEO
    Peterborough
    United Kingdom
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    Original Message


  • 4.  RE: MDR and EU Harmonized Standards

    Posted 31-Jan-2019 08:49
    Present "Harmonized" standards are only Harmonized to the MDD IVDD AIMDD. new Harmonized Standards will have to be prepared for the MDR and IVDR. Presently we are preparing the next version of ISO 14971 to be Harmonized and are working with EU designated Harmonization Consultants to prepare for Harmonization. Since there is significant differences between the directives and the regulations, significant work is needed.

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    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
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    Original Message


  • 5.  RE: MDR and EU Harmonized Standards

    Posted 31-Jan-2019 09:30

    At this time, there appears to be only one viable option, use the "soft transition" described in the EU-MDR Article 120(3). This allows marketing of a device with a CE Mark under the MDD as long as the manufacturer meets the QMS requirements in EU-MDR Chapter VII and the device specific requirements in the EU-MDD.

    Neither the MDD nor the MDR, has a requirement to follow a harmonized standard. However, it does provide a legal presumption of conformity.

    The harmonization process for the MDD is broken, the list has not been updated in more than a year. Also, it includes standards that have been obsolete for more than three or four years. As a result, some MDD Notified Bodies are asking manufacturers to use the current EN standards, not the harmonized standard citing the principle of state of art.

    Lastly, except for some Class I devices, a manufacturer cannot put the CE Mark on a device under the EU-MDR without a Notified Body. At this point, there is only one, the UK BSI. It is almost certain they will no longer be a Notified Body at the end of March 2019 because of a no-deal Brexit.

    In summary, discuss the issue with your MDD Notified Body, maintain your device under the MDD, and implement the post-market surveillance, market surveillance, and vigilance requirements under the EU-MDR.

    There are indications that the EU will have most of the mechanisms in place by the deadlines. However, if they meet the deadlines on the day, there is no time remaining for manufacturers to implement them.



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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 6.  RE: MDR and EU Harmonized Standards

    This message was posted by a user wishing to remain anonymous
    Posted 02-Feb-2019 08:06
    This message was posted by a user wishing to remain anonymous

    Thank you for all the comments......

    I should have mentioned that the device involved is not currently CE marked or sold commercially anywhere.  It is still under development and is therefore not likely to be able to be CE marked under MDD. This is due to development schedules as well as the likely difficulty in obtaining an NB during this transition phase. I have heard that many NBs are not even accepting new clients.
    Original Message


  • 7.  RE: MDR and EU Harmonized Standards

    Posted 04-Feb-2019 15:55
    Greetings to those on the trail here.  It is worth mentioning that BSI UK will most certainly continue to be a NB in the UK.  Brexit does not change that fact, the only thing that is impacted is acceptance of UK issued certifications by the remaining 27 member states.  To that end, in order to provide uninterrupted access to all of the EU, BSI's Netherlands office is designated under the current MDD and well on its way to MDR designation as well.  If anyone has questions or would like additional information, please feel free to reach out and I'll be happy to assist.


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    William Enos
    Ludlow MA
    United States
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    Original Message


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