What does B, M1 through M5 and the black triangle mean in MDD ?

SGquality

Quite Involved in Discussions
#1
In the MDD (93/42/EEC), there is "B" and M1 through M5" - what does that mean ? Also these alphabets have black triangles pointed either to right, or below or in between words.

What do all these mean ?
 
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SGquality

Quite Involved in Discussions
#3
You're looking at a consolidated version of the MDD that incorporates all of the modifications (Ms) into the original (B) version. The Ms with the numbers and triangles correspond to the modification number and what was modified.
Thanks Sarah.

If the B is the consolidated version, is there an A of the 93/42/EEC. On page 1, each of the M1 through M5 have documents mentioned against them. So when M1 / M2 / M3 / M4 / M5 appear in the text on subseuqnet pages, should it be replaced with the respective standard decsription as shown on page 1 ?
 

Sarah Stec

Involved In Discussions
#4
In examining the rest of the Directives I have on my desk, it doesn't look like there is an "A" version. It may be that the "A" version is the original version, but the original version doesn't have the cover page that the current version does, so it's not designated as the "A" version. I'm honestly not sure, and am happy to defer to my learned colleagues on this.

Where M1... appears in the text of the subsequent pages, it shows where M1... modified the text. The text you see is the modified text. I'm not sure what you mean when you ask if it should be replaced with the standard description on page 1 though. Could you please clarify?
 

Marcelo

Inactive Registered Visitor
#5
The official versions are the separate texts published on the OJ (for example, the original MDD is here: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:1993:169:FULL&from=EN) , the one with B and Ms are only for ease of use (it reads on the first page: This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents).

The original documents can be found here: http://ec.europa.eu/health/medical-devices/regulatory-framework/legislation/index_en.htm

Meaning of abbreviations - which indicate the type of act (from http://eur-lex.europa.eu/content/legis/avis_consolidation.html):


B = basic act
M = modifier
A = Accession Treaty
C = corrigendum
 
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