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2014/35/EU ( LVD Directive) Compliance for IVD ?

Discussion in 'EU Medical Device Regulations' started by QAengineer13, Apr 14, 2016.

  1. QAengineer13

    QAengineer13 Member

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    The LVD recast 2014/35/EU , ANNEX II: Equipment and Phenomena Outside the Scope of this Directive states , Electrical equipment for radiology and medical purposes , but there is no definition of medical purposes in the enore directive.

    I would like to know the following for an IVD manfacturer , do we need to comply to this Directive? as it explicitly states exclusion for medical purposes.

    Forum member who have already cross this bridge of compliance to LVD and EMC recst directive can you please share with me your thought? I feel LVD directive is not required for medical device compliance but wanted to confirm this with other SME's out in this forum.

    TIA!
     
  2. Ronen E

    Ronen E Well-Known Member

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    In my understanding where the MDD is applied the LVD is N/A. The electric safety of the device will be addressed via the MDD's essential requirements, which I think are more detailed and more onerous especially if we take into account that the highway to MDD electrical compliance is via EN 60601.

    I don't think the LVD recast introduced something new in that respect.
     
  3. QAengineer13

    QAengineer13 Member

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    Thanks Ronen, In our case its IVD directive and the electrical compliance is via EN 61010.
     
  4. Ronen E

    Ronen E Well-Known Member

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    Sorry, my bad.
    Essentially my synopsis stays the same.
     

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