Is GHTF Classification Structure similar to EU MDD Calssification

E

evilchilli_420

#1
Hello,

Can anyone please clarify if the GHTF classification structure (Class A,B,C,D) is comparable to the EU MDD classification structure (Class I, IIa,IIb, III)? Has anyone done a similar analysis and found it comparable?

Thanks in advance to your input.
 
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SteveK

Trusted Information Resource
#3
The GHTF classification goes back to at least 2003 and from the wording in the rules tables (with appropriate examples) is obviously based on the earlier MDD 93/42/EEC and the corresponding MEDDEV 2.4/1.
A side by side review of the GHTF/SG1/N77:2012 against the MEDDEV document pretty much shows that Class A, B, C & D are equivalent to Class I IIa, IIb and III respectively.

There are differences e.g. Rule 14 in MEDDEV is basically Rule 17 in GHTF document and other side by side rules do not fully match, and sometimes appear somewhat transposed. The reference to say blood bags appears in Rule 2 in the GHTF (Class C), but is separated as Rule 18 in the MDD/MEDDEV (Class IIb). This does not though seem to affect direct class by class comparisons (i.e. I = A, IIa = B, IIb = C & D = III) within the documentation.

Anyway that is my take on the subject.

Steve
 
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