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RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014 - Page 3


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Some Related Topic Tags (Not all threads are Tagged)
2014, lead (pb), mdd 2011/65/eu - electrical equipment hazardous substances, medical device standards and regulations, medical devices (general), mhra (medical & healthcare regulatory agency), rohs (restriction of hazardous substances)
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  Post Number #17  
Old 23rd July 2014, 11:28 AM
redknight07

 
 
Total Posts: 34
Re: RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014

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.

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  Post Number #18  
Old 14th August 2014, 03:30 AM
missjenny

 
 
Total Posts: 42
Re: RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014

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.
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  Post Number #19  
Old 14th August 2014, 04:54 AM
CharlieUK

 
 
Total Posts: 112
Re: RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014

Look at section 7 of http://ec.europa.eu/environment/wast...ee/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)
Thanks to CharlieUK for your informative Post and/or Attachment!
  Post Number #20  
Old 15th August 2014, 02:51 PM
redknight07

 
 
Total Posts: 34
Re: RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014

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

  Post Number #21  
Old 18th August 2014, 06:28 AM
missjenny

 
 
Total Posts: 42
Re: RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014

"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."

- The important part here is the term "stand alone." What does this mean? Does it simply mean that it is also sold separately or that they must be able to function or perform alone without the other components? If it is the latter, then obviously it will be in scope. Please help?
  Post Number #22  
Old 20th August 2014, 03:00 PM
redknight07

 
 
Total Posts: 34
Re: RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014

For devices that are intended to be sold outside of Europe and have a CE mark, what are the implications if the device is not RoHS compliant? Since this is a requirement only for devices headed to the EU, then should the CE mark be taken off the non-RoHS compliant devices headed to non-EU countries?

My opinion is that this would not be necessary since RoHS compliance is a requirement only for EU and as far as non-EU countries are concerned then devices can carry a CE mark even if non-RoHS compliant. Any suggestions on this?

Feedback most welcome.

Thanks,
Aniket
  Post Number #23  
Old 20th August 2014, 05:59 PM
Ronen E

 
 
Total Posts: 3,091
Re: RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014

Quote:
In Reply to Parent Post by redknight07 View Post

For devices that are intended to be sold outside of Europe and have a CE mark, what are the implications if the device is not RoHS compliant? Since this is a requirement only for devices headed to the EU, then should the CE mark be taken off the non-RoHS compliant devices headed to non-EU countries?

My opinion is that this would not be necessary since RoHS compliance is a requirement only for EU and as far as non-EU countries are concerned then devices can carry a CE mark even if non-RoHS compliant. Any suggestions on this?

Feedback most welcome.

Thanks,
Aniket
Hi,

This is a general question which exceeds the RoHS aspect. Let me rephrase please:

"Is it acceptable to market CE mark bearing devices in countries outside the EC while those devices are not fully compliant with all applicable CE mark related EC legislation?"

This question has been discussed here several times, and a search might yield useful answers. In short, it is problematic and in some cases - non-EC countries that formally rely on CE marking for regulatory market clearance - it's completely unacceptable.

In my personal view it's a form of deception. You will be making a statement that isn't true.

Cheers,
Ronen.

Last edited by Ronen E; 20th August 2014 at 06:35 PM.
Thanks to Ronen E for your informative Post and/or Attachment!
  Post Number #24  
Old 25th August 2014, 07:27 PM
redknight07

 
 
Total Posts: 34
Please Help! Re: RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014

Quote:
In Reply to Parent Post by Ronen E View Post

Hi,

This is a general question which exceeds the RoHS aspect. Let me rephrase please:

"Is it acceptable to market CE mark bearing devices in countries outside the EC while those devices are not fully compliant with all applicable CE mark related EC legislation?"

This question has been discussed here several times, and a search might yield useful answers. In short, it is problematic and in some cases - non-EC countries that formally rely on CE marking for regulatory market clearance - it's completely unacceptable.

In my personal view it's a form of deception. You will be making a statement that isn't true.

Cheers,
Ronen.


Thank you for the clarification, Ronen. I do follow that for a device to bear a CE mark, it has to comply with all the requirements mandated as per the European Directive.

For approval/registrations in non-EU countries, if the devices have a CE mark or approval/clearance in the US, then the registration process is relatively easy due to the extensive requirements for approval in US or in the EU. What possibly could be the impact if the CE mark had to be taken off for devices headed to these countries! Notifying the authorised representatives? Contacting the regulatory bodies? Re-registering the devices? Maze.
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