What is the relation between MDD 93/42/EEC and Biocide 98/8/EC

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YAZ YAZ

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Hello every body :bigwave:

I am a new member and i have a question :cool:

As per the subject What is the relation between MDD 93/42/EEC and Biocide 98/8/EC and how regulation authorities deal with this sitution in matter of classification and registration.

thanks all
 
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#5
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YAZ YAZ said:
Hello every body :bigwave:

I am a new member and i have a question :cool:

As per the subject What is the relation between MDD 93/42/EEC and Biocide 98/8/EC and how regulation authorities deal with this sitution in matter of classification and registration.

thanks all
Click to expand...
Biocidal products are defined in Article 2, 1 (a) and Annex V gives the exhaustive list of biocidal products in the 98/8/EC.
If your have a product and is a biocidal product, however if your instrument is more classified as a Medical device within the 93/42/EEC., then the 98/8/EC does not apply for you.
See Scope 2. in 98/8/EC.
2. This Directive shall apply to biocidal products as
defined in Article 2(1)(a) but shall exclude products that
are defined or within the scope of the following
instruments for the purposes of these Directives:
(h) Council Directive 93/42/EEC of 14 June 1993
concerning medical devices (8),
 
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