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RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014
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RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014
RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014
RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014
RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014
RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014
RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014
RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014
RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014
RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014
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Some Related Topic Tags
2014, lead (pb), mdd 2011/65/eu - electrical equipment hazardous substances, medical device standards and regulations, mhra (medical & healthcare regulatory agency), rohs (restriction of hazardous substances), medical devices
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  Post Number #25  
Old 26th August 2014, 12:28 AM
Ronen E

 
 
Total Posts: 3,432
Re: RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014

Hi,

The answer depends on whether the (non EC) country of interest relies on the CE mark in its regulatory clearance process.

If it doesn't - I reckon that you can take away the CE mark without notice, provided that that action doesn't afect any significant aspect of the device. At most, document a letter to file with your reasoning for not notifying any one.

If it does - you'd probably need to re-clear on the merits of the device itself, without its (obsolete) CE marking.

Cheers,
Ronen.
Thank You to Ronen E for your informative Post and/or Attachment!

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  Post Number #26  
Old 8th November 2014, 02:42 PM
Welshgar

 
 
Total Posts: 3
Re:implications of use of non CE medical devices

Steve,

I am new to the forum so not sure about route to post questions to correct discussion.

I am an audiologist and many colleagues are now using suction equipment for a purpose it was not specified for and there is no equipment available in the UK with CE approval or that manufacturers will give approval to for this use. What are the legal and personal implications?
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  Post Number #27  
Old 8th November 2014, 06:17 PM
Ronen E

 
 
Total Posts: 3,432
Re: implications of use of non CE medical devices

Quote:
In Reply to Parent Post by Welshgar View Post

Steve,

I am new to the forum so not sure about route to post questions to correct discussion.

I am an audiologist and many colleagues are now using suction equipment for a purpose it was not specified for and there is no equipment available in the UK with CE approval or that manufacturers will give approval to for this use. What are the legal and personal implications?
Try here
Thank You to Ronen E for your informative Post and/or Attachment!
  Post Number #28  
Old 9th November 2014, 12:32 PM
Welshgar

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

The manufacturer and country of use is the UK?
  Post Number #29  
Old 9th November 2014, 05:46 PM
Ronen E

 
 
Total Posts: 3,432
Re: RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014

Quote:
In Reply to Parent Post by Welshgar View Post

The manufacturer and country of use is the UK?
MHRA = UK's official Medicines and Healthcare products Regulatory Agency.

http://www.mhra.gov.uk/Aboutus/index.htm

The country where the manufacturer is located is irrelevant in that regard.

Cheers,
Ronen.
Thanks to Ronen E for your informative Post and/or Attachment!
  Post Number #30  
Old 23rd August 2016, 04:25 PM
Critical Care

 
 
Total Posts: 6
Re: RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014

HI Steven K,

Does a MD manufacturer must have a seperate DoC for the RoHS directive or the CE DoC is enough ?
  Post Number #31  
Old 24th August 2016, 04:07 AM
SteveK's Avatar
SteveK

 
 
Total Posts: 787
Lurker Re: RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014

I have separate DoC for the RoHS Directive in my Technical File for electrical medical devices. Our NB expected this to be the case even if it does not come under their remit.

Steve
Thanks to SteveK for your informative Post and/or Attachment!
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