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  • 1.  MDD/MDR Annex I vs 2001/83/EC

    Posted 14-May-2020 11:36
    Edited by Adam Atherton 14-May-2020 13:28
    I think I know this answer, but I am getting pushback. I would appreciate input.

    Planning for gaining approval for a PFS through 2001/83/EC in EU. Does the device part, the syringe, still need to comply with MDD/MDR Annex I?

    I say yes because Article I (clauses 3 and 4) is plain in stating so, but perhaps I am missing something.

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    Adam Atherton
    Farragut TN
    United States
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  • 2.  RE: MDD/MDR Annex I vs 2001/83/EC

    Posted 15-May-2020 06:02
    Hi Adam,

    You are correct.  Under the EU MDD I think is fairly clear about the device portion, but either it was not enforced strongly or not well understood even after all these years.  But under the EU MDR under Article 117 this is much more clear the device portion needs to be 'assessed' by a Notified Body.  What this assessment means is still not quite so clear and have been many discussion in conferences and forums about how this is going to be put in reality by Notified Bodies and EMA.  I would agree with you saying Yes, because in the MPD Section 3.2, Section 12 says 'if needed' CE Marking on the device.  In Article 117 it is much more clear the device needs to conform with Annex I.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: MDD/MDR Annex I vs 2001/83/EC

    Posted 15-May-2020 17:19
    Thank you, Richard.

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    Adam Atherton
    Farragut TN
    United States
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    Original Message


  • 4.  RE: MDD/MDR Annex I vs 2001/83/EC

    Posted 16-May-2020 07:34
    Hi Adam, Richard

    I do have different inputs. Please review and comment.

    The EU MDR Date of Application has been extended until May 2021.

    If the application for the MRP/RUP is submitted on or after 26 May 2021, then the GSPR and Article 117 of the MDR will need to be met and the supporting documentation such as the Declaration of Conformity, certificate of conformity or notified body opinion should be included in the dossier.

    Regards
    Swapnil Jain
    Regulatory Specialist
    Philips Healthcare

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    Swapnil Jain
    Regulatory Affairs Specialist
    Best
    Netherlands
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    Original Message


  • 5.  RE: MDD/MDR Annex I vs 2001/83/EC

    Posted 16-May-2020 08:50
    Thank you Swapnil.

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    Adam Atherton
    Farragut TN
    United States
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    Original Message


  • 6.  RE: MDD/MDR Annex I vs 2001/83/EC

    Posted 16-May-2020 08:16

    Adam,

     

    You are correct.  The MDD effectively has the same wording as is now in the MDR, with the MDR requiring and NB opinion to be sought and now filed with the MAA.  So, technically, if the PFS was viewed as what is now called a Drug Delivery Combination (DDC) by EMA, it would need to meet Annex 1 of the MDD.

     

    The reality is that a PFS is a very bad case for a combination product for a number of reasons.  Mostly because  it has been successfully addressed, reviewed, approved and safely and effectively marketed and used as a drug product with a suitable Primary packaging in both the US and EU without any additional controls or requirements as a medical device.  It was only after FDA's insistence that this was a Combination Product was there, after a significant delay, the beginnings of a call for submission of an "Essential requirements Checklist" outlining compliance with Annex 1 of the MDD, which I believe is the current expectation.

     

    My personal belief is that a PFS should not be a Combination Product or a DDC and should be safely and effectively addressed in a submission as a drug product with Primary Packaging that has be chosen and tested to be suitable for it intended use. This belief in the concepts of least burdensome, and "if it is not broken, don't fix it" I fear are lost in the mindless, bureaucratic wave.

     

    So, the short answer is yes, it is required.

     

    Now back to the weekend!

     

    Lee Leichter

    President

    P/L Biomedical

    10882 Stonington Avenue

    Fort Myers, FL 33913 USA

    Office: +1-239-244-1448

    Cell: +1-239-994-6488

    Email: leichter@plbiomedical.com

     




    Original Message


  • 7.  RE: MDD/MDR Annex I vs 2001/83/EC

    Posted 16-May-2020 08:51
    Thank you Lee.

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    Adam Atherton
    Farragut TN
    United States
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    Original Message


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