EU proposing amending’s in requirements for devices for self-testing and requirements for HIV and HCV rapid tests

European Commission proposes decision updates the common technical specifications, provided for 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 definitions of first line and confirmatory assays, requirements for self-tests and requirements for HIV and hepatitis C virus rapid tests and confirmatory assays.

Products covered: In vitro diagnostic medical devices

HS Code: 3002300

Proposed date of adoption:4th quarter 2019

Proposed date of entry into force:20 days from publication in the Official Journal of the EU. There is a transition period of 12 months following entry into force of the regulation.

Final date for comments:60 days from notification

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