MDCG guidance

MDCG 2021-7: Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices

MDCG guidance · COVID-19 · May 2021

Key facts

Reference MDCG 2021-7
Title Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices
Topic COVID-19
Published May 2021
Document health.ec.europa.eu

At a glance

  • Yes Full text searchable in Orca1
  • MDCG 2021-7 (May 2021) 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

Browse all MDCG guidance documents