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  • 1.  RoHS for medical devices. Technical documentation

    Posted 28-Mar-2017 10:29

    I'm going to be doing a RoHS compliance audit for a series of medical devices for Europe. The 2011/65/EU indicates a need for technical files. What does the community suggest is sufficient technical documentation to demonstrate the claim of RoHS compliance?

     

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    Paul Martin

    Quality Systems and Regulatory Affairs Specialist

    P: +1.847.590.7175 | M: +1.989.698.6676 | paul.martin@rauland.com

     

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    Rauland is a Division of AMETEK, Inc.

    1802 W Central Rd | Mount Prospect, IL 60056 | www.rauland.com

     



  • 2.  RE: RoHS for medical devices. Technical documentation

    Posted 28-Mar-2017 12:28
    EN50581 guidance document was released to clarify Technical Files requirements related to RoHS directive 2011/65/EU.  I hope this helps.






  • 3.  RE: RoHS for medical devices. Technical documentation

    Posted 29-Mar-2017 04:11
    Hi Paul,

    In addition to the general technical documentation file in line with the MDD, which include (but not limited to):

    • General description of the product
    • Documentation of Product design structure and information showing the relationship of conformity documentation with material, parts, and subassemblies in the product
    • Risk assessment of materials, parts and subassemblies
    • Conformity information on materials, parts, and subassemblies
    • Manufacturing documentation and records
    • Harmonized standards, specifications, and conformity procedures that have been applied to ensuring the conformity of the product 

    You should also be looking at more specific data to support RoHS compliance:

    • Procedures/trainign and RoHS Responsibilities Assessment, including any RoHS program, compliance review, audit
    • Bill of materials from suppliers, including things like declaration of conformity from the supplier, materials declaration and also supplier assessment
    • Risk analysis/Risk assessment of Bill of Materials and Suppliers and risk mitigation data (ideally with refernce to the Rism management File, part of the technical file)
    • RoHS testing, and storage
    • Any information  on compliance assurance system (CAS) with restricted substance controls (RSC) and other certifications , such as Environmental Certification

    Hope this helps

    Ana

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    Ana Cruz
    Johnson & Johnson Medical Ltd
    Wokingham
    United Kingdom
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