MDCG guidance

MDCG 2021-23: Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

MDCG guidance · Notified bodies · August 2021

Key facts

Reference MDCG 2021-23
Title Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Topic Notified bodies
Published August 2021
Document health.ec.europa.eu

At a glance

  • Yes Full text searchable in Orca1
  • MDCG 2021-23 (August 2021) Revisions on file

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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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