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  • 1.  EU PPE Regulation - Electronic Instructions for Use

    This message was posted by a user wishing to remain anonymous
    Posted 17-May-2021 17:28
    This message was posted by a user wishing to remain anonymous

    Hi,

    I was unable to find anything in the PPE regulation regarding the ability to use electronic instructions supplied by the manufacturer vs physical paper. I was wondering if there is a separate regulation or guidance document that talks about that. If anyone has background on this topic and could provide insight I would really appreciate it.

    Thank you.


  • 2.  RE: EU PPE Regulation - Electronic Instructions for Use

    Posted 18-May-2021 02:40
    Hi Anon,

    The relevant EU Regulation in your case is probably 207/2012 "on electronic instructions for use of medical devices". In an nutshell, it limits eIFUs to devices intended for professional users, states that paper-based information still needs to be made available on request of the user, and demands a specific risk assessment by the manufacturer.

    Hope this helps!

    Best regards,
    Michael

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    Michael Kemmann
    Managing Director
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    Original Message


  • 3.  RE: EU PPE Regulation - Electronic Instructions for Use

    Posted 18-May-2021 04:17
    Agreed with Michael. Check out EU Regulation 207/2012 specifically Articles 3 and 5. They discuss scenarios in which manufacturers may provide eIFU rather than paper form for certain devices (Article 3) and for certain conditions (Article 5).

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    Lawrence Maddela
    Regulatory Affairs Specialist
    Edwards Lifesciences
    Irvine CA
    United States
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    Original Message


  • 4.  RE: EU PPE Regulation - Electronic Instructions for Use

    Posted 18-May-2021 07:41
    Hi Anon:
    If you Declare Conformity under (EU)2016/425, the PPE Regulation, there is no provision for electronic labeling as far as I know.
    If you Declare Conformity under 93/42/EEC the MDD and include compliance to the PPE Regs EHSRs, electronic labeling (EU)207/2012 does indeed apply.
    If you Declare Conformity under (EU)2017/745, the MDR and include compliance to the PPE EUSRs, the new EU Implementing Act will apply (EU)2021/XXX currently under consultation Ref. Ares(2021)2803762 - 27/04/2021
    Whatever you do, you need to make sure you meet PPE EHSRs (EU)2016/425 Annex II paticularly 1.4
    For MDD speakers: PPE EHSRs = MDR GSPRs = MDD ERs = Essential Requirements, the things you have to meet under the legislation concerned.

    But unless you have a complex device for use by professionally trained staff, or medical device software, you'll have to keep chopping down those trees and printing the paper!
    Best Regards
    Neil

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    Neil Armstrong FRAPS
    CEO MeddiQuest MeddiQuest Limited
    MeddiQuest
    Peterborough
    United Kingdom
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    Original Message


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