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Updates on proposed EU Medical Device Regulations - June 2016
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Updates on proposed EU Medical Device Regulations - June 2016
Updates on proposed EU Medical Device Regulations - June 2016
Updates on proposed EU Medical Device Regulations - June 2016
Updates on proposed EU Medical Device Regulations - June 2016
Updates on proposed EU Medical Device Regulations - June 2016
Updates on proposed EU Medical Device Regulations - June 2016
Updates on proposed EU Medical Device Regulations - June 2016
Updates on proposed EU Medical Device Regulations - June 2016
Updates on proposed EU Medical Device Regulations - June 2016
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Updates on proposed EU Medical Device Regulations - June 2016 - Page 3


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2016, european union, ivd (in vitro diagnostic) devices and reagens, mdd (medical device directive), revisions to a document or standard
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  Post Number #17  
Old 10th October 2016, 11:47 PM
Julie O

 
 
Total Posts: 221
Re: Updates on proposed EU Medical Device Regulations - June 2016

Does anyone happen to have an old list of NBs, circa 2010-2013? I would be interested in tracing the impact of the new regulations/recertification on the NB landscape.

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  Post Number #18  
Old 11th October 2016, 03:48 AM
pkost

 
 
Total Posts: 824
Re: Updates on proposed EU Medical Device Regulations - June 2016

the nando website lists expired/withdrawn/suspended notifications, unfortunately you can't filter by date:

http://ec.europa.eu/growth/tools-dat...ications%2FNBs
Thanks to pkost for your informative Post and/or Attachment!
  Post Number #19  
Old 27th April 2018, 05:08 PM
me too

 
 
Total Posts: 2
Re: Updates on proposed EU Medical Device Regulations - June 2016

What is the status of own brand manufacturing?
  Post Number #20  
Old 29th April 2018, 05:48 AM
RobertvanBoxtel

 
 
Total Posts: 58
Re: Updates on proposed EU Medical Device Regulations - June 2016

OBL / OEM / Private labeling / Virtual manufacturer.

Just a few words used in relation to each other. In the end, none are defined in MDD/AIMD/IVDD or MDR/IVDR.

The MDR/IVDR are most clear, MDR: look into Article 10. That's what you need to have. And next, look into Article 51 to classify your device. Depending on the classification, look into Article 52 for the conformity assessment to be followed.

This means that anybody (natural or legal person) placing a device on the market needs to be able to demonstrate all these elements (and more...).

Only if you can do that, you are manufacturer.
  Post Number #21  
Old 29th April 2018, 07:48 AM
Thielen

 
 
Total Posts: 1
Re: Updates on proposed EU Medical Device Regulations - June 2016

Quote:
In Reply to Parent Post by Marcelo Antunes View Post

This is a common problem with complex documents with several subjects and different layers of revision. See ISO 13485:2016 for another example :-P
Have you completed your General Safety and Performance Requirements check list? Is it available for members?
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