The MDCG 2022-1 Notice has been published
It is addressed to manufacturers of SARS-CoV-2 IVDs based in a third country and who place or intend to place their in vitro diagnostics on the EU market.
It highlights a number of common issues that EU national competent authorities have identified in the course of their market surveillance activities regarding the compliance with the requirements of the IVDD and can also be relevant for SARS-CoV-2 devices which are transitioning to the IVDR.

Read more.

Meditrial serves as an EU Authorised Representative. We can help you comply with the European legal requirements and establish constructive relationships with Competent Authorities, Notified Bodies, hospital networks, the European Commission, and industry associations.

Contact Meditrial for immediate assistance in Europe and in the US.

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