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  • 1.  Checking ROHS compliance during CE audit

    Posted 27-Apr-2014 02:06
    The ROHS Directive will become obligatory for many medical devices on 22 July 2014. Does anyone know if a Notified Body will check (or has the authority to check) ROHS compliance when it (NB) performs an annual ISO and CE audit as per the European Medical Directive? 

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    Asher Kassel
    Lifewatch Technologies Ltd.
    Rehovot
    Israel
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  • 2.  RE:Checking ROHS compliance during CE audit

    Posted 28-Apr-2014 02:44

    According to the linked guidance document from eucomed - no. 

    http://eucomed.org/uploads/Modules/Publications/130522_paper_on_rohs_ce_marking.pdf
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    Inbal Ben-Tzvi, RAC
    Vice President, Regulatory Affairs
    Sensible Medical Innovations
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    Original Message


  • 3.  RE:Checking ROHS compliance during CE audit

    Posted 29-Apr-2014 14:54
    The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry [COCIR] issued a RoHS II guidance document, "Guide on RoHS II Directive" dated April 2013.  Here is the URL - http://www.cocir.org/site/fileadmin/Publications_2013/COCIR_Guide_ROHS_II_April_2013.pdf.   In that document on pages 8 and 9, they discuss the CE Marking requirements for RoHS II and state that the technical documentation will not be audited by a notified body. They actually provide the information listed below on the CE Marking .  Note that they recommend adding a statement that the RoHS compliance is under the sole responsibility of the manufacturer - see bolded wording below.

    7.3. CE MARKING

    The NLF requires only one CE marking to be added to products. RoHS II requirements regarding

    CE marking do not affect CE marking requirements with regard to other directives applying to the

    product itself.

    For medical devices requiring a CE marking with the numerical suffix identifying the notify body,

    such as medical devices class IIb, and IIa, no additional CE marking is required.

    In case of class III medical devices, the documentation to be submitted to Notified Bodies is not

    required to contain any references to manufacturer procedures or tests to ensure RoHS

    compliance.

    To avoid that the use of this CE mark can be interpreted as the Notified body also assessed the

    manufacturer processes to ensure RoHS compliance, it is advisable to add a statement in the DoC

    explaining that RoHS compliance is ensured under the sole responsibility of the manufacturer.

           

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    Dixie Sells
    VP RA
    Sandy UT
    United States
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    Original Message


  • 4.  RE:Checking ROHS compliance during CE audit

    Posted 30-Apr-2014 09:56

    At this point in time, this is my interpretation.

    As for "Restricted Hazardous Substances in Medical Devices" (RoHS), manufacturers are required to fulfill the requirements pursuant to Decision No. 768/2008/EC

    Under Annex II Module A, it states ",,the manufacturer fulfils the obligations... and ensures and declares on his sole responsibility that the products concerned satisfy the requirements..."

    It also states "...The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the product's conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s)..."

    It further states "The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation..."

    Thus, a manufacturer (e.g.,  electrical and electronic products) shall ensure they meet the requirements as set out in the RoHS.


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


  • 5.  RE:Checking ROHS compliance during CE audit

    Posted 28-Apr-2014 20:06
    Hi Asher,

    At a recent RAPS meeting in the California Bay Area, we had several folks from BSI come to speak. Their take, at that time, was that they would not be auditing for RoHS compliance, as part of annual ISO and CE audits. They were taking the tack that it was outside their authority.

    I am myself very curious who has or will have the authority to audit for RoHS compliance. Does anyone have any updates?

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    Joanne Pelaschier RAC
    Quality Engineer
    Stellartech Laboratories
    Sunnyvale CA
    United States
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    Original Message


  • 6.  RE:Checking ROHS compliance during CE audit

    Posted 09-May-2014 17:40
    It is up to each member state in the EU see per UK below and link to web site. Our NB also stated thay have no authority to review RoHS during Tech File Audits

    Request for Information

    Why have I received a letter requesting information?

    As the market surveillance authority responsible for enforcing the RoHS Regulations within the UK, the NMO carry out regular market surveillance projects to ensure compliance and offer support to businesses who are trying to comply with the Regulations.

    If you have received a letter from us, on behalf of the Secretary of State, requesting information about your company, this is because we have identified you as a responsible company who may import, rebrand or manufacture electronic and electrical equipment.

    This information must be provided within the timeframe as specified by us and we ask you to follow the instructions in the letter, answering the request to the best of your ability. This will include accessing a secure 'https' website.

    If at a later date we need further information, we will contact you.


    http://www.bis.gov.uk/nmo/enforcement/rohs-home/FAQs#Rohs
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    Barry Welenc
    Manager, Quality & Regulatory
    Philips Healthcare - Dunlee
    Aurora IL
    United States
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    Original Message


  • 7.  RE:Checking ROHS compliance during CE audit

    Posted 03-May-2014 17:29
    As a regulatory requirement for your product, the ROHS II should be an input of your design procedure (ISO 9001 or 13485) if you have one, and a requirement for the final product release.

    If the CAP for CE marking include the quality system of part of it, you can well expect to be asked by a regular quality system audit.

    I've been asked during a 13485 audit, together with other directives compliance.


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    Marco Catanossi MS
    Ing. Marco Catanossi - VAT Nr. IT02996670549
    Foligno
    Italy
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    Original Message