MDCG guidance

MDCG 2022-1: Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices

MDCG guidance · COVID-19 · January 2022

Key facts

Reference MDCG 2022-1
Title Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices
Topic COVID-19
Published January 2022
Document health.ec.europa.eu

At a glance

  • Yes Full text searchable in Orca1
  • MDCG 2022-1 (January 2022) Revisions on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MDCG guidance documents

The Medical Device Coordination Group (MDCG), made up of EU member-state experts, endorses guidance on applying the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746. Each page here covers one document and all of its revisions.

Source: European Commission, Medical Device Coordination Group (MDCG) endorsed documents and other guidance. © European Union, reused under Commission Decision 2011/833/EU

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