RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014

[katapult]

Ah, that happens when writing posts on the fly.

Mark you're correct with your statement about homogenous material!

 

[redknight07]

If I am interpreting the directive correctly, all products sold after the 22 July 2014 deadline need to be in compliance to the RoHS 2 directive and the subsequent modifications should be implemented in the technical file/DoC before sending out the product. So the deadline exists just to ensure that no product is released without compliance to RoHS 2, if within the scope of the directive.

If a product was in a transition stage and will not be available to place on the market until much later after the deadline, the technical files/DoC can be updated at a later date, irrespective of the RoHS 2 deadline, but before the product is placed on the market? Is this accurate or am I insane.

Cheers,
Aniket

 

[Ronen E]

If I am interpreting the directive correctly, all products sold after the 22 July 2014 deadline need to be in compliance to the RoHS 2 directive and the subsequent modifications should be implemented in the technical file/DoC before sending out the product. So the deadline exists just to ensure that no product is released without compliance to RoHS 2, if within the scope of the directive.

If a product was in a transition stage and will not be available to place on the market until much later after the deadline, the technical files/DoC can be updated at a later date, irrespective of the RoHS 2 deadline, but before the product is placed on the market? Is this accurate or am I insane.

Cheers,
Aniket

Hi,

The RoHS recast is applicable to devices in it's scope that are placed on the market after the deadline. If a RoHS-recast-non-compliant device is initially placed on the market before the deadline, it is OK to further sell it (distribute it) after the deadline.

If a device is not placed on the EC market then there are no EC obligations regarding it's technical file. So, I think that the answer to your question is yes.

Cheers,
Ronen.

 

[redknight07]

Greetings,

To all those who have been involved in the RoHS transition process, have you applied the standard IEC/TR 62476 "Guidance for evaluation of products with respect to substance-use restrictions in EE products" for RoHS compliance at your place? It talks about having a restricted substance controls procedure, the other requirements seem somewhat similar to that required from suppliers in 50581 clause 4.3.3 to show RoHS compliance. There's just too many standards out there!

In a nutshell, I've moved in this new position only recently and was not involved in the RoHS planning process from the beginning. The practices to ensure that only RoHS compliant parts and components are purchased is in place it is just the documentation of the technical file and the revision of quality procedures which is in transition.

In the Tech Files, the content affected by RoHS Directive was the DoC and certain places within the essential requirements checklist where the RoHS standard was also referenced. I have included a section specifically in the Tech File that based on requirements of EN 50581 clause 4.3.3, we have collected supplier declaration and material declaration from suppliers as a means to show compliance to RoHS. Nothing else stands out to me at this moment regarding changes in the Tech File. Any opinion on this?

It is when it comes to its impact on procedures that I feel a bit short sighted. Few that come to mind are:

Purchasing Procedures: to ensure that RoHS material obtained is from an approved supplier and includes a DoC that the material is RoHS compliant.

Receiving Inspection: to include instructions to check for RoHS compliance when receiving (something along these lines)

Supplier evaluation procedure: To state that those suppliers who provide critical components requiring RoHS compliance will be assessed accordingly.

Correction and removal procedures: to include that whenever a Non RoHS complaint product is released after deadline then perform Recall procedure, initiate NCR procedure, correction and removal. I believe all these 3 procedures or more will need revision for RoHS.

Risk Management File: to include statement saying that we trust the DoC/Material description provided by suppliers and will be auditing them yearly, something along these lines.

this is roughly the list of procedures that I feel will need to be revised. There are plenty which I would have missed here and hence needed your opinion.

Any advice would be most welcome.
Thank you, apologies for the long message.

 

[Mark Meer]

It is when it comes to its impact on procedures that I feel a bit short sighted.

My advice: less is more. Don't over-complicate your procedures. Or, if changes are needed to deal with something specific (e.g. RoHS), consider generalizing rather than adding a ton of "if-then" caveats.

For example, non-conformances and vigilance procedures probably don't have to be changed. If you have stated (in your design specifications or wherever, the the product shall be RoHS2 compliant, then presumably any non-RoHS should be handled like any other non-conformance.

As for purchasing & receiving, we've got a checkbox on our purchase orders for RoHS:
- Include with shipment (receiving inspection personnel responsibility to verify)
- Confirmed (if supplier posts it on their website or sends it by email. purchasing has responsibility)
- N/A (for non-RoHS items)

As for supplier evaluations: again, try to keep it general and don't paint yourself in a corner. Over-arching requirements such as "RoHS=audits" is just going to become a burden to you. For example you might just add:

"Suppliers of components in the scope of the RoHS2 Directive must provide evidence of RoHS compliance for the items purchased in the form of a DoC and/or material test-report. Provisional approvals may be granted, however justification for any deviations must be documented."

This gives you a lot of flexibility. Supplier can't provide RoHS DoC? Maybe they can still be granted provisional approval with justifications such as: products not for European market, you have done your own material tests,...

have you applied the standard IEC/TR 62476 "Guidance for evaluation of products with respect to substance-use restrictions in EE products" for RoHS compliance at your place?

I'm not familiar with IEC 62476, but as far as I can tell, it is not a harmonized standard, therefore it does not presume conformity to a Directive (in this case RoHS2 Directive). Nevertheless, it might be helpful as guidance, and if so use it. ...but with non-harmonized standards, you can afford to pick-and-choose what you believe are the relevant parts to help demonstrate Directive conformance.

Best.

 

[CharlieUK]

EN 50581:2012 is the only Harmonised Standard (HS) for RoHS.

Whilst HS are not mandatory, they do give a presumption of conformity and enforcement authorities, such as customs, seem to operate on the basis that HS are required. They're not, but it's often easier to comply with one than to try and explain why you are compliant to a person who doesn't understand.

One important distinction that 50581 makes is that not all suppliers are equal and therefore you are likely to need different levels of assurance from different suppliers in your supply chain.

regards
Charlie

 

[redknight07]

Thank you for the feedback, Charlie. Compared to IEC/TR 62476 which seems to be an overly demanding standard, compliance with EN 50581 seems less exhausting. You mention about suppliers, for class I devices if they are distinguished as critical and non-critical then I think that would suffice.

As for a Restricted Substance Control (RSC) program, if the necessary changes have been implemented in the quality procedures then is there a need to have separate RSC process implemented? The RSC would typically contain employee responsibilities, department responsibilities and reference of only those procedures which has steps on how to implement RoHS.

Thanks guys, great help.

 

[missjenny]

RoHS II Scope:

I know that IVDs such as blood glucose meters will be in scope in 2016.

1. Would non-EEE components such as test strips, lancets, and lancing devices also be in scope if sold together as a blood glucose monitoring system package?

2. What about manuals, inserts, and packaging materials? Would they be in ROHS 2 scope as well?

Based on my limited research, manuals and packaging materials are exempted and if the EEE and non-EEE components are fully functional apart from each other, then only the EEE would be in scope even if they are sold together as a package. I would highly appreciate it if somebody could confirm the above. FYI, my NB swears that #1 & 2 would be included as well.

 

[CharlieUK]

Look at section 7 of http://ec.europa.eu/environment/waste/rohs_eee/pdf/faq.pdf

If your NB is convinced they're included (and I'm not) ask them to for the citation of the requirement.

(Note, your NB is only an NB for MDD, there are no NBs for RoHS)

 

[redknight07]

As far as what I know of Blood Glucose Monitoring Devices, its components such as lancets/lancing devices and test strips are also sold separately. Under Q 7.3 in the FAQ document it is stated that stand alone components do not require to be in compliance. This "may" apply to these components and hence put them out of scope. Hopefully, someone with experience can add to this.

As far as manuals, inserts and packaging material is concerned, response to Q 8.9 clearly states that RoHS 2 does not apply to any manuals, documentation, consumables etc. that do not have an equipment constituent as well as any packaging intended to be discarded soon after putting the equipment into service.

One suggestion: for components/materials/parts which do not fall under the scope of RoHS 2 requirements, create a document listing them along with references from this FAQ document which prove that they don't need to be in compliance.

Hope this helps.
Aniket

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