Marcelo Antunes

Addicted to standards
Staff member
Admin
#1
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/register/en/content/out/?&typ=ENTRY&i=LD&DOC_ID=ST-9364-2016-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/register/en/content/out/?&typ=ENTRY&i=LD&DOC_ID=ST-9365-2016-REV-1
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#3
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:

SteveK

Quite Involved in Discussions
#5
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
 

pkost

Quite Involved in Discussions
#6
It's worth noting that these documents are still not final! Changes can and are likely to be made to address issues like this
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#7
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
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#8
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).
 

RobertvanBoxtel

Involved In Discussions
#9
One should indeed question what the purpose of the ENVI meeting was regarding this proposal text with so many errors, incorrect numbering etc etc.
Look in Annex XV: It suggests contact lenses are not devices with a medical purpose, being on this list. Strange? No, it was there from the initial proposal. Apparently no reader saw this, nor was member of EP, EC or Council noted to this by the industry....

In short, more water will flow through rivers before all will be clear.
 

Top