ARE YOU READY FOR
THE EU MDR?

The deadline to the EU Medical Device Regulation directive is approaching.
Are your IFUs compliant with the new requirements?

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EU MDR Timeline

There are several important dates to remember during
the implementation of the new regulation.

MAY 26, 2017

EU MDR Published and Entered into Force.

EU MDR Published and Entered into Force.

NOV 26, 2017

Notified Bodies may apply for designation according to the EU MDR.

Notified Bodies may apply for designation according to the EU MDR.

MAY 26, 2021

MDR date of Application. EC Certificates of Conformity issued before May 26th, 2017 will expire.

MDR date of Application. EC Certificates of Conformity issued before May 26th, 2017 will expire.

MAY 26, 2022

EUDAMED will go live.

EUDAMED will go live.

MAY 26, 2024

Notified Body certificates issued under AIMDD and MDD designation become void.

Notified Body certificates issued under AIMDD and MDD designation become void.

MAY 26, 2025

Devices certified under the AIMDD and MDD can no longer be sold or distributed.

Devices certified under the AIMDD and MDD can no longer be sold or distributed.

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    touch

    For more information on how Argos Multilingual can support you and your business with the
    EU MDR directive and its requirements, please reach out to us by filling in this form.

    mdr@argosmultilingual.com +1 (303) 516-0857 (US) +353 1 503 0978 (EU)

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