ASRs (Analyte Specific Reagents) and GPRs Regulation in EU?

sreenu927

Quite Involved in Discussions
#1
Hi all,

Which directive is relevant for registering Analyte Specific Reagents (ASR) and General Purpose Reagents (GPRs) in EU?

For RUO instruments,we follow LVD and EMC Directives and place CE Marking.

But for ASR and GPR (antibodies, cell culture medium, etc..) which regulations in EU apply so that we can put CE Marking?

Thanks,
Sreenu
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
Another quick "Bump". My Thanks in advance to anyone who can help with this one.
 

bio_subbu

Super Moderator
#4
Hi all,

Which directive is relevant for registering Analyte Specific Reagents (ASR) and General Purpose Reagents (GPRs) in EU?

For RUO instruments,we follow LVD and EMC Directives and place CE Marking.

But for ASR and GPR (antibodies, cell culture medium, etc..) which regulations in EU apply so that we can put CE Marking?

Thanks,
Sreenu
Hi Sreenu

Please note that there is no classification in EU equivalent to the US ASR. Regarding your GPR question, refer to “Article 1(2) (b) of the IVDD” and the attached EU guidance document MEDDEV 2.14/1 revision 2 "GUIDELINES ON MEDICAL DEVICES IVD Medical Device Borderline and Classification issues A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES" particularly Section 1.4.

According to “Article 1(2) (b) of the IVDD” products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination”.
 

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