Informational Medtech Europe guidance – Use of Symbols to Indicate Compliance with the MDR

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#2
Hi Marco,
Thanks as usual for your information on the EU MDR compliance.

I know I have seen it and hope that you can point me in the right direction. I always search before asking this type of question so please forgive me if I appear to be “lazy” or “possess lack of knowledge” - nothing could be further from the truth!

Somewhere, I found an overall point-by-point comparison between Rev. 4 and the MDR besides the correlation table at the back of the MDR.

In other words, a plain “English” comparison without having to reference one item after another.

Did I have a dream about this? If I did, then it is on my todo list to make this happen!

Saludos,
Valerie

PS what I have done, if it would be useful to anyone are two documents:

1. The MDR Word-converted with a TOC - not an external TOC but one embedded with a start at cross-references.
2. An excel spreadsheet of all the definitions from Article 2 - sorted alphabetically or however you want. I have learned to stop taking for granted definitions that seem “intuitive”.
 
#4
MEDDEV 2.7/1 rev. 4 vs. MDR 2017/745

Sorry I wasn’t clear - a comparison of the differences/new requirements. This may not be something I thought I had found.

As of today, the companies where I have consulted have been audited by their NB ( in some cases) and the deficiencies have all been related to what I originally referred to as Rev. 4 since that is the only “qualified” standard at the moment m.

However, any company I have worked for wants to understand what it will take to be compliant with the MDR - trying to streamline the process even though it is a work in progress.

Hope this helps - there is a huge capital requirement/burden on these companies and it is my job to help them be as efficient as possible with the transition.

Thanks Marcelo
 

Marcelo

Inactive Registered Visitor
#5
There's no real comparison between MEDDEV 2.7/1 rev. 4 and the MDR, because they are different things. The comparison in principle should be between MDD 93/42/EEC and MDR 2017/745, for example, because they are the mandatory, legally binding requirements (defending what is expected).

Although MEDDEV 2.7/1 rev. 4 ended up being somewhat "mandatory" to follow, it's really a guidance on "how" to apply the requirements of the Directives.
 
#6
Thank you and I understand your response but I am sure you can understand why people involved are looking for this. There are ways to make an analogy on some items and I think that will help to some extent. I will search the all the articles I have saved and try to come up with something to assist those who haven't read every page like I have of the MDR. In fact, that may be my issue at the moment. I have moved off of the MDD 93/42/EEC and have spent more time lately with the MDR from the ``forward thinking" perspective.

As usual, I appreciate your insight.
 
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