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EU - Commission proposed updates in common technical specifications of vitro diagnostic medical devices

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EU – Commission proposed updates in common technical specifications of vitro diagnostic medical devices

European Commission has issued notification proposing decision updates the common technical specifications, set out in article 5.3 of the Directive 98/79/EC on in vitro diagnostic medical devices, for some in vitro diagnostic medical devices according to the state of the art, notably regarding HCV antibody/antigen combined tests and Nucleic Acid Amplification techniques ("NAT") assays for HIV.

The objective of this decision is to improve the level of safety of some in vitro diagnostic medical devices put on the EU market: specifically hepatitis C virus (HCV) antibody/antigen combined tests and nucleic acid amplification technique (NAT) for HIV assays.

It will reinforce the control by notified bodies of the placing on the market of these in vitro diagnostic medical devices, ensure an equal level playing field for all industry actors and a better functioning of the internal market.

Proposed date of adoption: 4th quarter 2017

Proposed date of entry into force: 20 days from publication in the Official Journal of the EU. There is a transition period of 6 months following entry into force of the regulation.

Final date for comments: 60 days from notification

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.

 


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