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  • 1.  MDD/CMDR Checklist

    Posted 28-Mar-2012 17:50

    Hi there

    Would anyone have information as to what a registrar auditor will be looking for when they refer to the MDD/CMDR checklist?

    Any information is appreciated
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    Liliana Omar
    QA Manager / Reg. Affairs
    Maple Grove MN
    United States
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  • 2.  RE:MDD/CMDR Checklist

    Posted 29-Mar-2012 06:13
    Hi Liliana
    MDD = European Medical Device directive 93/42/EEC. See http://eur-lex.europa.eu/LexUriServ/site/en/consleg/1993/L/01993L0042-20031120-en.pdf

    CMDR = Canadian Medical Device Regulations SOR/98-282. See http://laws-lois.justice.gc.ca/PDF/SOR-98-282.pdf. Watch out for regular updates!

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    Oscar Banz
    Head of QM & RA
    Haag-Streit AG
    Koeniz
    Switzerland
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    Original Message


  • 3.  RE:MDD/CMDR Checklist

    Posted 29-Mar-2012 08:49
    Greetings, Liliana. Yes, I can give some insight into this. For the MDD, the registrar will be looking for compliance to Annex 1. Annex 1 of the MDD, or the Essential Requirements, are the requirements that all medical devices, regardless of class, must adhere to. In my past experience, I have merely copied the requirements directly from Annex 1 into a checklist and then completed the checklist for each device. Also be aware that the MDD asks for evaluation as to whether a medical device is subject to the Personal Protective Equipment standard (Directive 89/686/EEC) and the Machinery Directive (2006/42/EC). I merely have taken the requirements from those standards and added them to the requirements of Annex 1 in the same checklist. I have had no issues.

    As for the CMDR, it's the same process, but the sections of the regulation the registrar will be concerned about are CMDR Sections 10-20 (Safety and Effectiveness Requirements) and Sections 21-23 (Labeling Requirements). I merely made a checklist of those sections and I assess the medical device against them. I hope this helps.

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    Carroll Martin
    Manager, Regulatory Affairs
    US Endoscopy
    Mentor OH
    United States
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    Original Message


  • 4.  RE:MDD/CMDR Checklist

    Posted 29-Mar-2012 23:38
    Thank you all for the very valuable information and taking the time to share your knowledge.

    Carroll

    You are correct and accurate, in addition to the ER checklist, the auditor was looking for PPE and machinery statements, in addition he was looking for the EU rep contract, Canadian distribution contract, EU declaration of conformity and label draft. I thought on sharing this for future reference.

    My best,


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    Liliana Omar
    QA/ Reg. Affairs Manager
    Maple Grove MN
    United States
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    Original Message


  • 5.  RE: MDD/CMDR Checklist

    Posted 24-Nov-2015 20:46

    Does this mean that these two directives (Machinery and PPE) need to be addressed as either applicable or non-applicable in the ER Checklist (or other statement in the Technical File)? If they are not addressed at all, would this be considered a non-conformance? 

    Thank you,

    Jon

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    Jon Cook
    San Jose CA
    United States

    Original Message


  • 6.  RE:MDD/CMDR Checklist

    Posted 29-Mar-2012 09:39
    Perhaps they are referring to the Essential Requirements Checklist to demonstrate conformity to Annex I of the MDD.

    Certain sections of the CMDR (Canada Medical Devices Regulations) map into the requirements of the MDD.  I've seen them combined into one checklist.

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    Lex Pearce RAC
    Regulatory Affairs Manager
    Salt Lake City UT
    United States
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    Original Message


  • 7.  RE: MDD/CMDR Checklist

    Posted 26-Nov-2015 05:03

    Hi all,

    with regards to the issue of the Machinery Directive.

    The manufacturer of a MD shall follow and comply with the MDD. This includes, but not limited to, demonstrate compliance of the MD to the ERs of the MDD. If the MD is also a machine according to the definition of machine of the Machinery Directive, the manufacturer must also demonstrate compliance to ERs of the Machinery Directive. The latter does not imply any obbligation to fulfill the whole machinery directive. It is just the ERs of the Machinery directive which add to the list of the ERs of the MDD, but the directive followed to place the MD on the market is only the MMD.

    With regards to the PPE.

    Sorry I don't remember, but it should work as the Machinery Directive

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    Lorenzo Muratori
    Elekta
    West Sussex
    United Kingdom

    Original Message