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  • 1.  CE Marking - Machinery Directive 2006/42/EC

    This message was posted by a user wishing to remain anonymous
    Posted 14-Feb-2018 13:26
    This message was posted by a user wishing to remain anonymous

    ​Does anyone know if Machinery Directive 2006/42/EC applies to medical devices?


  • 2.  RE: CE Marking - Machinery Directive 2006/42/EC

    Posted 14-Feb-2018 19:11
    Edited by Jon Cook 14-Feb-2018 19:25
    If the medical device is considered to be machinery, then yes it applies.  
    You need to have a statement of applicability  (or non-applicability) somewhere in your technical file. even if the medical device is not considered to be machinery.


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    Jon Cook
    San Jose CA
    United States
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    Original Message


  • 3.  RE: CE Marking - Machinery Directive 2006/42/EC

    Posted 15-Feb-2018 02:25
    As Jon says, if your medical device falls under the scope of the Directive, then it must be have all of the applicable parts applied.  An example, is milling machines used in dentistry, electronic device for staple placemtn, or electric saws for bone or casts.  The technical documentation file needs to include the Essential Health and Safety Requirements (EHSR) - which you can do very similar to the Essential Requirements is using a checklist to go through and show which requirements are applicable and then how they are met.  When the Medical Device Directive 93/42/EEC was revised in 2007 to Revision M5, this included clarification that the Machinery Directive 2006/42/EC no longer excluded medical devices from scope like the previous version did.  The Machinery Directive application date was back in 2009 and MDD M5 was back in 2010, so it must be fully applied currently.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 4.  RE: CE Marking - Machinery Directive 2006/42/EC

    Posted 15-Feb-2018 09:58

    Dear Anonymous,

    The reference is given in Article 3 to apply certain aspect of the Machinery Directive and it was introduced with the last big update of the MDD in 2007 (M5).

    "Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery ( 24 ) shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to this Directive."

     

    With the heavy discussion on this topic also in regards to the PPE directive reference in Article 1 the Commission published informative documents on how to apply these two directives on medical devices.

     

    http://ec.europa.eu/DocsRoom/documents/10261/attachments/1/translations

     

    http://ec.europa.eu/DocsRoom/documents/10262/attachments/1/translations

     

    Good luck!

     

     

     

     

     

     

    Thank you for your continuous support.

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    Ludger Möller
    President
    Medical Device Safety Service GmbH
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    30175 Hannover, Germany 
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