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Technical File - machinery directive/PPE directive

Discussion in 'EU Medical Device Regulations' started by Jon Cook, Nov 24, 2015.

  1. Jon Cook

    Jon Cook New Member

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    Hi all,
    Is it a requirement to include/address the applicability or non-applicability of the following (from the MDD-M5) somewhere within the technical file? Would this be considered a non-conformance if it wasn't included?

    • Regarding the applicability or non-applicability of personal protective equipment as specified in Article 1 Section 6 of the MDD (quoted below).

    MDD Article 1 - 6. Where a device is intended by the manufacturer to be used in accordance with both the provisions on personal protective equipment in Council Directive 89/686/EEC (1) and this Directive, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.

    • Regarding the applicability or non-applicability of the machinery directive, as specified in Article 3 of the MDD (quoted below).

    MDD Article 3. 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 (5) 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.

    Thanks !

    Jon
     
  2. Steve Kent

    Steve Kent Member

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    Hi Jon,
    I could be wrong, but personally I do not think showing compliance to either the Machine or PPE Directive has to be in the medical device Technical File. However, I do believe that you would need to have evidence of conformity somewhere to show compliance; if applicable, to a NB/auditor. I our case we have a type of bracket that can hold one of our medical devices. This has accessible moving parts so can be deemed to come under the Machine Safety Directive. This has had certain testing to show that it will hold and retain the device under adverse conditions (to a test in a published Standard). So in a brief separate file I have copy of the test certificate, a hazard risk assessment, maintenance details, IFU, drawings, material details and finally a Declaration of Conformity (with our details) to the Machine Safety Directive signed off by our MD (note other than the DoC, risk assessment and material details, the rest of the bracket details are already in the TF as it is an accessory). I think this is enough cover (as the NB cannot audit directly against this Directive) and believe it is evidence to show compliance as per Article 3 of the MDD (and ward off any potential NC). We do not have anything that could be viewed as also being PPE, but I would think a similar approach would show compliance. Ultimately I think it is up to you to include (or not) such extra compliance details in your TF, I have just chosen to keep a separate DoC file.
    Steve
     
  3. Ronen E

    Ronen E Well-Known Member

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    Steve,

    By "Machine Safety Directive", do you mean the Machinery Directive (95/16/EC)? To count as "Machinery", an article would need a drive, other than direct human force or gravity. Having some moving parts is essenial but on its own not suficient to qualify as Machinery.

    Further, if an article qualifies as an Accessory to a Medical Device it should normally be handled similar to a Medical Device under the MDD. As such, the only requirement applicable in relation to the Machinery Directive is as the OP has quoted, i.e. the Machinery Directives's ERs in the limited sense mentioned. At least that's my understanding of both directives. It sounds to me as if your file goes way beyond the minimum requirement.

    Cheers,
    Ronen.
     
  4. applelee

    applelee New Member

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    Jon,

    Where a relevant hazard exists, devices which are also machinery (PPE), as defined in Directive 2006/42/EC (Directive 89/686/EEC), shall meet the essential health and safety requirements of Annex I of the machinery directive (PPE) where they are more specific than those in Annex I of the MDD.
    It's a minor nonconformity if there was no evidence that the relevance of the Machinery Directive (PPE) had been considered.
    The solutions adopted to fulfill the essential requirements are incomplete.

    Lee
     
  5. Ronen E

    Ronen E Well-Known Member

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    Sorry, of course I meant Directive 2006/42/EC (Machinery)...
     
  6. Steve Kent

    Steve Kent Member

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    Ronen,

    Yes that's the Directive I mean. As for going OTT on my file, you just cannot anticipate how an NB auditor/reviewer thinks!

    Steve
     

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