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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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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 #1  
Old 11th June 2016, 09:35 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,232
Look! Updates on proposed EU Medical Device Regulations - June 2016

Some recent developments on the proposal medical devices regulations in Europe.

Announcement from last week: Medical devices: deal reached on new EU rules

Official Journal 10-06-16 - Amendments on the proposal for revision of the directives - https://lnkd.in/eKTKRjC

Revised Medical Devices proposal on the Consilium website posted 10-06-16 (the document is not available to outside sources, as far as I can tell it's for the participantes of the meeting on 15-06-16) - http://www.consilium.europa.eu/regis...364-2016-REV-1

Revised IVD Medical Devices proposal on the Consilium website posted 10-06-16 (the document is not available to outside sources, as far as I can tell it's for the participantes of the meeting on 15-06-16) -
http://www.consilium.europa.eu/regis...365-2016-REV-1
Thank You to Marcelo Antunes for your informative Post and/or Attachment!

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  Post Number #2  
Old 13th June 2016, 04:13 AM
pkost

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

My understanding of a blog post by Erik Vollebregt, is that the documents will be made public on Wednesday 15th June
Thank You to pkost for your informative Post and/or Attachment!
  Post Number #3  
Old 13th June 2016, 08:14 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,232
Re: Updates on proposed EU Medical Device Regulations - June 2016

Quote:
My understanding of a blog post by Erik Vollebregt, is that the documents will be made public on Wednesday 15th June
Yes, that's what I was told too. Anyway,it's gonna be soon, finally.

Last edited by Marcelo Antunes; 13th June 2016 at 09:54 AM.
  Post Number #4  
Old 13th June 2016, 09:54 AM
Marcelo Antunes's Avatar
Marcelo Antunes

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

Here are the revised texts: http://www.emeeting.europarl.europa....1/sitt-2571597
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #5  
Old 15th June 2016, 07:38 AM
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Lurker Re: Updates on proposed EU Medical Device Regulations - June 2016

I drafted a “Medical Device Regulation Compliance General Safety & Performance Requirements” checklist from earlier drafts of Annex I of the proposed MD Regulations, starting back at the beginning of 2013. Obviously this will be needed to replace the Essential Requirements checklist document for Technical Files. I was “being prepared” like the good Boy Scout I used to be – assuming back then that the publication was on the cards (silly me). So going through the current Annex I (going up for today’s EU meeting) I am amazed at the number of typos, certainly one missing clause title and other possible mistakes in a document that has been around for so long! Not checked the whole Regulation (at 355 pages) – suppose I will have to read it all eventually (yawn). Heaven knows what will happen during the translation to all the official EU languages!

Steve
  Post Number #6  
Old 15th June 2016, 07:50 AM
pkost

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

It's worth noting that these documents are still not final! Changes can and are likely to be made to address issues like this
  Post Number #7  
Old 15th June 2016, 07:54 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,232
Re: Updates on proposed EU Medical Device Regulations - June 2016

Quote:
I drafted a “Medical Device Regulation Compliance General Safety & Performance Requirements” checklist from earlier drafts of Annex I of the proposed MD Regulations, starting back at the beginning of 2013. Obviously this will be needed to replace the Essential Requirements checklist document for Technical Files. I was “being prepared” like the good Boy Scout I used to be – assuming back then that the publication was on the cards (silly me). So going through the current Annex I (going up for today’s EU meeting) I am amazed at the number of typos, certainly one missing clause title and other possible mistakes in a document that has been around for so long! Not checked the whole Regulation (at 355 pages) – suppose I will have to read it all eventually (yawn). Heaven knows what will happen during the translation to all the official EU languages!
This is a common problem with complex documents with several subjects and different layers of revision. See ISO 13485:2016 for another example :-P
  Post Number #8  
Old 15th June 2016, 08:07 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,232
Re: Updates on proposed EU Medical Device Regulations - June 2016

Quote:
It's worth noting that these documents are still not final! Changes can and are likely to be made to address issues like this
Yep.

On the other hand, I asked some people with knowledge about possible changes at this stage and the understanding (as I expected) is that probably the changes at this time would not be technical in nature; it seems that this time the lawyers will have a final look to make sure that the legal part of the text is ok. But this would also include cosmetic and editorial corrections.

This may also be the reason that several "mistakes"were not included, meaning, people discussing the technical aspects may have left some open knowing that someone would take a more careful view of these details (not the best action course in my opinion, but sometimes it's needed, otherwise the text never goes to the next stage).
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