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MDR and IVDR to be published May 5th 2017
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MDR and IVDR to be published May 5th 2017
MDR and IVDR to be published May 5th 2017
MDR and IVDR to be published May 5th 2017
MDR and IVDR to be published May 5th 2017
MDR and IVDR to be published May 5th 2017
MDR and IVDR to be published May 5th 2017
MDR and IVDR to be published May 5th 2017
MDR and IVDR to be published May 5th 2017
MDR and IVDR to be published May 5th 2017
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Some Related Topic Tags
2017, european union, ivd directive, ivdr (in vitro diagnostic regulations), mdr (medical device regulations), regulations and regulatory requirements
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  Post Number #9  
Old 8th May 2017, 11:30 AM
Chrisx

 
 
Total Posts: 107
Re: MDR and IVDR to be published May 5th 2017

I created bookmarks for each chapter and article. I find it makes navigating the document much easier. I have attached it in case anyone else would like to use it.
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf EU MDR (final published in OJ).pdf (1.47 MB, 119 views)
Thank You to Chrisx for your informative Post and/or Attachment!

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  Post Number #10  
Old 9th May 2017, 11:10 AM
nozzle

 
 
Total Posts: 14
Re: MDR and IVDR to be published May 5th 2017

Quote:
In Reply to Parent Post by L_O_B View Post

I have heard several customers over the last years asking for a gap analysis and here is what I told them:

A gap analysis between MDD and MDR is a lot of work for almost no benefit.

The MDR contains a lot of information and by far not everything has an impact on economical operators.
-> so filter what is important for your business

The MDR contains a lot of requirements, which were already part of (harmonised) standards (e.g. ISO EN 13485:2016, ISO EN 14971:2012, ISO EN 14155:2011) or guidances (e.g. MEDDEV 2.7/1)
-> I guess most of the people here work in companies, which are already producing/selling devices. The main pillars of regulatory compliance are:
Risk Management
Usability
Clinical Evaluation
Labeling
Post-market surveillance
and all this should be part of a working quality management system.
This is nothing new but the status how it already should be.
So in order to comply with the MDR, instead of torturing yourself through articles about how frequently the MDCG shall meet or how the commission shall establish the interface of Eudamed (and also searching for equivalences in the MDD for that), it may be smarter to check for gaps between what you already have established and what the MDR requires.
Additionally, if you have already or are about to implement standards like ISO 13485:2016 or IEC 62366-1, you would have twice the work (first the gap analysis between MDR and MDD; second the gap analysis between standard and MDR).
The technical documentation is another good example for this. The MDD has almost no requirements on the format of the technical documentation. So people decided to use templates like STeD. If you use such a template, where is the benefit in comparing MDD and MDR requirements on this topic.

There are sections where a gap analysis between MDR and MDD might help (general safety and performance requirements <-> essential requirements), but for the whole document this is not helpful

The MDR is no MDD 2.0.

Thanks for taking the time to reply.
We received a major non-conformance from our NB last week as we don't have a procedure for conducting clinical evaluation. The company have never been cited for this in the past, do you have an example procedure?
Thanks to nozzle for your informative Post and/or Attachment!
  Post Number #11  
Old 9th May 2017, 06:53 PM
Ronen E

 
 
Total Posts: 3,736
Re: MDR and IVDR to be published May 5th 2017

Quote:
In Reply to Parent Post by nozzle View Post

We received a major non-conformance from our NB last week as we don't have a procedure for conducting clinical evaluation. The company have never been cited for this in the past
This has nothing to do with the advent of the MDR.

The MDD, Annex X, section 1.1 says:

Quote:
...The evaluation of this data, hereinafter referred to as ‘clinical evaluation', where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure...
You could argue with your NB that a procedure can be defined without being documented - good luck with that...

Further, the requirement is spelled out in MEDDEV 2.7/1 (see A.12.3.1), which is not officially mandatory but is practiced by NBs as such.

Last edited by Ronen E; 9th May 2017 at 07:06 PM.
  Post Number #12  
Old 10th May 2017, 03:02 AM
L_O_B

 
 
Total Posts: 16
Re: MDR and IVDR to be published May 5th 2017

Quote:
In Reply to Parent Post by nozzle View Post

Thanks for taking the time to reply.
We received a major non-conformance from our NB last week as we don't have a procedure for conducting clinical evaluation. The company have never been cited for this in the past, do you have an example procedure?
I really like my job and I am pretty sure that the day I publicly post a clinical evaluation procedure will be my last day at this job.
If you want to implement a procedure, as Ronen said, the MEDDEV 2.7/1 Rev 4 is your go to document. Work through the paper and create tasks of the requirements. If you are struggling at doing this, maybe you have to involve someone professional.

Now asking the real questions: Where did your clinical evaluation report for approval come from? Did you write one yourself without procedure? Did someone external write it? But why the major then?
Thanks to L_O_B for your informative Post and/or Attachment!
  Post Number #13  
Old 10th May 2017, 04:35 AM
nozzle

 
 
Total Posts: 14
Re: MDR and IVDR to be published May 5th 2017

Quote:
In Reply to Parent Post by L_O_B View Post

I really like my job and I am pretty sure that the day I publicly post a clinical evaluation procedure will be my last day at this job.
If you want to implement a procedure, as Ronen said, the MEDDEV 2.7/1 Rev 4 is your go to document. Work through the paper and create tasks of the requirements. If you are struggling at doing this, maybe you have to involve someone professional.

Now asking the real questions: Where did your clinical evaluation report for approval come from? Did you write one yourself without procedure? Did someone external write it? But why the major then?
Thanks for the reply

No idea why the major, I have heard varying stories on how NB's are interpreting this differently.
  Post Number #14  
Old 13th May 2017, 02:40 PM
Sam Lazzara's Avatar
Sam Lazzara

 
 
Total Posts: 266
Re: MDR and IVDR to be published May 5th 2017

Attachment 19549
Quote:
In Reply to Parent Post by Chrisx View Post

I created bookmarks for each chapter and article. I find it makes navigating the document much easier. I have attached it in case anyone else would like to use it.
I took your bookmarked version of the medical devices regulation and added a Table of Contents I found on the internet. No idea if it is an accurate TOC but it might be.
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf Europe Regulation (EU) 2017_745 of 5 April 2017 on medical devices, with TOC.pdf (1.39 MB, 90 views)

Last edited by Sam Lazzara; 14th May 2017 at 12:45 AM.
Thanks to Sam Lazzara for your informative Post and/or Attachment!
  Post Number #15  
Old 7th May 2018, 01:42 PM
Sam Lazzara's Avatar
Sam Lazzara

 
 
Total Posts: 266
Re: MDR and IVDR to be published May 5th 2017

NAMSA just published the best version of the new European device regulations I have seen so far.


Table of Contents...check.
ToC Bookmarks...check.

Internal hyperlinks...OMG...check!
It must have taken hundreds of hours to create the hyperlinks in this thing!

Now you have fewer reasons to avoid reading the new regulations.
Check it out here. Published with permission from NAMSA.
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