Regulatory Open Forum

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  • 1.  94/62/EC Packaging and Waste Directive

    Posted 28-Jul-2014 12:43
    I wanted to know if any other medical device companies were asked to declare conformity to the essential requirements in the Packaging and Packaging Waste Directive 94/62/EC? Our company was recently asked to declare conformity to this directive and I wasn't sure if it applies to medical device packaging or not?

    Thanks for your feedback,
    Katie 

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    Katie Welliver MS
    Minneapolis MN
    United States
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  • 2.  RE: 94/62/EC Packaging and Waste Directive

    Posted 28-Jul-2014 13:20
    Katie,

    I was intrigued by your question. 

    I knew there is a legislative movement in EU about this particular Directive originally issued in 1994 and then amended in 2005 (External Link).  

    It applies for "primary packaging for medical devices and pharma products."  (0.1% by weight)

    Is your NB based in Austria, Belgium, or the Netherlands?

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    http://www.regulatorydoctor.com
    Riner VA
    United States
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    Original Message


  • 3.  RE: 94/62/EC Packaging and Waste Directive

    Posted 28-Jul-2014 13:53
    Hi David,

    Thank you for you prompt reply. The request is from France. They are asking we meet the following essential requirements: The total content of heavy metals does not exceed 100ppm, the content of noxious or hazardous substances does not exceed 0.1%, the packaging can be recycled (is this referring to both the outer and inner package?).

    Thanks,
    Katie

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    Katie Welliver MS
    Minneapolis MN
    United States
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    Original Message


  • 4.  RE: 94/62/EC Packaging and Waste Directive

    Posted 28-Jul-2014 14:11
    Katie,

    "Primary Packaging" is defined as it constitutes "a sales unit to the final user or consumer at the point of purchase."

    Accordingly, it refers to the outer package(s) only.  

    However, since it is also possible that France may have their own requirements, you may want to send an email to your NB to convey your interpretation, stating that your analysis of the outer packages only would meet both the 94/62/EC (Amended on 16 March 2005) and the NB's, if any, under France's national law.  

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    http://www.regulatorydoctor.com
    Riner VA
    United States
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    Original Message


  • 5.  RE: 94/62/EC Packaging and Waste Directive

    Posted 29-Jul-2014 02:10
    My understanding of this directive is that its purpose is to ensure packaging waste sent to landfill and for recycling does not contain hazardous materials and thus does not contaminate the environment or batches of recycled material. All packaging waste generated or imported into Europe should comply to this directive. However, I have never seen this statement in ERs, which are supposed to be related to the safety and effectiveness of the device in the context of patient or user, not the environment. See this extract from the Europa website:

    "For this reason, economic operators and Member States approached the Commission to introduce comprehensive legislation on packaging.  In 1992, the Commission came forward with a Proposal for a Council Directive on Packaging and Packaging Waste.  Following a prolonged discussion in the European Parliament and the Council of Ministers, Directive 94/62/EC was adopted.

    This Directive aims to harmonise national measures in order to prevent or reduce the impact of packaging and packaging waste on the environment and to ensure the functioning of the Internal Market.  It contains provisions on the prevention of packaging waste, on the re-use of packaging and on the recovery and recycling of packaging waste."

    Hope this helps

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    Teresa Perry
    BSI
    Hedge End
    United Kingdom
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    Original Message


  • 6.  RE: 94/62/EC Packaging and Waste Directive

    Posted 30-Jul-2014 07:08
     I agree, It should not be in the essential requirements. But, yes compliance is also required for medical devices. I have often seen distributors asking for information to the manufacturer so that they can comply and give the information they need to the local instancies. Application of the directive is left to the member states.  Some will raise very important fees to non-recyclable packaging.

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    Patrick Manouvriez
    MP.QRA Services Sprl
    Péruwelz
    Belgium
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    Original Message