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#67831 11/06/14 9:53 AM
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Its my understanding that all new medical devices purchased after June 2014 in EU must be RoHS compliant. Medical devices were previously exempt but are now covered. Have any EBME teams amended their commissioning process to address this? RoHS is a manufacturers obligation, but I'm wondering whether our acceptance procedures should be changed and whether this is another area that needs 'policing'.

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Sage
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RoHS Compliance Transitional arrangements

By now, medical device manufacturers should have decided which devices are going to be made RoHS compliant and which, if any, will be made obsolete. The directive allows noncompliant devices to be placed on the EU market until 22 July 2014 for medical devices and 22 July 2016 for IVDs. These devices can be in the distribution chain until 22 July 2019. Taking full advantage of these transitional periods, however, may conflict with customer expectations for the availability of compliant devices?

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Cheers Sean. I can't find any details about the transitional period. Do you have a link to a document that explains this? Do people think its an area were EBME will have to challenge suppliers? Or will they kick the ball into the long grass? (football analogy essential during World Cup!)

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Sage
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European Medical Device Technology -Compliance and Regulatory

Demonstration of compliance with RoHS II has been made easier, however, with the publication of European standard EN 50581:2012, Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances, which provides a template for collation of the necessary evidence. EN 50581 became a harmonised standard with regard to the RoHS II Directive in November 2012, so meeting the standard will provide a presumption of conformity to the relevant parts of RoHS II.

Perhaps its time to update local use of the June 2003 PPQ, to specifically include checking compliance with EN50581 when purchasing new medical device products?

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Wasn't (isn't) the infamous "C.E. Mark" meant to take care of all this?

You know:- "one sticker, and all is well"? If not, what's the point of it (apart from yet another "money spinner", of course)? whistle

But don't worry guys; there will be a whole new tranche of this stuff heading our way once TTIP (the US-EU trade agreement) goes through. And it will - be in no doubt about that! frown

You can expect the on-going privatisation of the NHS to take on fresh momentum shortly after. That is, out of Stealth Mode and into the open.

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Thanks for the link Sean. Some useful information there and as you say the transition period will perhaps be a supplier 'get out' clause. The CE mark should be all we need to know as far as compliance goes.One interesting quote from the article states:
"It should be noted that there is no Notified Body involvement in the conformity assessment to RoHS II. That is, Notified Bodies assessing manufacturers for compliance with the medical device directives should not need to be involved in the conformity assessment required by RoHS II."
So I take it that this a manufacturer self assessment of their product for conformity,which could be a contentious area. I've already had one supplier kicking off that their competitors product was non compliant.

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There is a problem with the C.E. mark now as well, in that someone has created an unofficial "rip-off" where the lettering is identical but with the letters closer together. They are calling it the "China Export" mark. It is obviously designed to confuse.

As the CE mark can be a self-assessed device these days, we can only go on what companies tell us on either CE mark or the RoHS II compliance.

Companies complaining about their competitors being non-compliant are naughty. They are there to sell their own kit, not spread rumours about their competition. I have no respect for reps who spend more time disparaging their rivals than they do saying "look, it does this...". It is poor rep practice, and I have had to deal with it myself recently too.

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Has anyone yet amended their commissioning paperwork (PPQ June 2003) to reflect compliance with RoHs II? Is it enough just to ask for the Manufacturer's copy of the Declaration of Conformity and check that it complies with EN 50581?

Found this interesting snippet of information

Article 13(2) of the RoHS2 Directive states that the EU Declaration of Conformity shall contain the following elements and shall be updated
1. Model number or other means of uniquely identifying the product
2. Name and address of the manufacturer or his authorised representative
3. Statement that the EU Declaration of Conformity is issued under the sole responsibility of the manufacturer
4. Object of the declaration (identification of the product allowing traceability. It may include a photograph, where appropriate)
5. Statement that the object of the declaration described above is in conformity with the RoHS substance restrictions
6. Where applicable, references to the relevant harmonised standards used or references to the technical specifications in relation to which conformity is declared

7. Signature on behalf of the producer (name, function) and date of issue
Article 7(g) of the RoHS2 Directive requires the Manufacturer to ensure that the product bears a type,batch or serial number or other element allowing its identification, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document
accompanying the product.

Article 7(c) of the RoHS2 Directive 2011/65/EU states that where the Manufacturer can demonstrate that the required technical documentation has been drawn up and the internal production controls in line with Module A of Annex II of Decision 768/2008/EC have been implemented, then the Manufacturer can affix the CE marking to the finished product. [i]If the Manufacturer has already affixed the CE marking to the product to claim conformity to another Directive (for example the Medical Devices Directive) and the Manufacturer continues to supply the product after the date that the product is required to comply with the RoHS2 requirements, under Article 16 (1) of RoHS2 this CE marking now means that the Manufacturer is also claiming that their product conforms to the RoHS substance restrictions. If a single EU Declaration of Conformity is developed to cover several Directives, then the EU Declaration of Conformity should state that compliance to the RoHS2 Directive requirements is the sole responsibility of the Manufacturer.[/i]

Link thingy!

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Master
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I can't find anyone who knows what RoHS even means. Or WEEE or CoSHH.

Who is Georg Ohm (correct spelling), L. M Ampere, A. G. A.A. Volta.

Confused.com.


Jim Gavin
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... or, indeed, Aloysius Alzheimer! whistle

(he died young, you know, back in the days before antibiotics)

Ampère's initials were A.M., by the way (André-Marie). And how come you haven't mentioned James Watt, Jim? After all, he was British (or, if you prefer, Scottish)! smile


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