Regulatory Open Forum

 View Only

  • 1.  Essential Requirement Checklist

    Posted 29-Sep-2016 13:10

    Hello everyone,

    I'm currently working on updating the Essential Requirement Checklist document (part of our EU Design Dossier) as we recently made some modifications to an existing device. Do you know whether we should still keep all the existing documents (which belong to the existing design) in the Identity of Specific Documents column and just continue adding new documents that are applicable to the enhanced design? Is there a specific guidance/requirement of what documents should go in the Identity of Specific Documents column? I couldn't find any EU or GHTF guidance in helping clearing this question.

    Thank you!

    ------------------------------
    Tam Luong
    LSI Solutions
    Victor NY
    United States
    ------------------------------


  • 2.  RE: Essential Requirement Checklist

    Posted 30-Sep-2016 12:04

    In my opinion and experience, I would use the currently ERC that was included in your original dossier and up rev it to include the additional supporting documentation that needs to be included due to the modification.  I don't believe there is a specific guidance for this situation out there.  

    ------------------------------
    Adam Cargill
    Warsaw IN
    United States

    Original Message


  • 3.  RE: Essential Requirement Checklist

    Posted 30-Sep-2016 13:48

    Hello Tam,

    I agree with Adam that you want to keep the original history and do a revision level ERC update as a new revision document.  Meaning keep the original ERC and copy it and make a rev level for the changes as long as for the same product or product line depending how you maintain your ERC's

    LSI Solutions is a client I have worked with many years ago so if you need some additional support please feel free to contact me.

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com

    Original Message


  • 4.  RE: Essential Requirement Checklist

    Posted 01-Oct-2016 21:56

    Related to this question, if you just update a file, how long is the review by the notified body? Similar to a new one, or perhaps faster?


    Original Message


  • 5.  RE: Essential Requirement Checklist

    Posted 08-Oct-2016 21:29

    Hi Samir,

    It depends on the type of change that you going to update your Essential Requirements. Changes like change of manufacturing sites, change of material, change of manufacturing process or change of intended use will required notified body involvement and usually take longer lead time for documents / site audits.

    It is recommanded that you send a notification of change to your notified body, notify them on the type of change and let them proposed & guided you the compliance process that going to take place.

    Thanks!

    ------------------------------
    Winson
    Regional Regulatory Affairs Executive
    Singapore

    Original Message


  • 6.  RE: Essential Requirement Checklist

    Posted 10-Oct-2016 09:40

    Sharing my experience in the last 4 years this is what we have done. 

    We list in the Essential Requirements Checklist, the latest approved version of the documentation. For example: In the Essential Requirement 4., one of several documents listed for evidence of conformance is the Sterilization Report. 

    We do Re qualification of Sterilization Process every two years, and therefore this report is updated every two years. If we have a total of 5 revisions of this report, then we include in the essential requirement, only the latest version of this document. e.g: 20-0010 Rev 5. 

    This practice was adopted after one of BSI auditors provided us the feedback. 

    In the case of Design Enhancement, I guess that it depends on the situation. Two months ago, we notified our CE mark notified body (BSI) about a substantial change performed to one of the main components of the system that we have in the market, an software controlled electronic device. We had one Technical File week audit. The auditor went all over the Essential Requirements Checklist and out Technical File Summary. We successfully passed the audit with Zero observations. 

    After the design was modified, we assigned a new part number to the product. The reason of assigning a new part number to a modified device was because of Traceability purposes. The enclosure of the device was reduced, power consumption was reduced, more alarms were included, better ingress protection, etc. However, there are still original, or old design devices in the market, therefore we are listing in the Essential Requirements Checklist all documents: The old documentation, associated with the old device, and the new documentation associated with the enhanced device. As soon as the original design is removed from the market, we will list only the latest revisions of the documents associated with the enhanced device. 

    ------------------------------
    Edenia

    Original Message