The EU Medical Device Coordination Group (MDCG) is responsible for issuing guidance on the application of EU Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR). These documents provide clarity on regulatory compliance for manufacturers and stakeholders in the medical device industry.
Medical Device Coordination Group (MDCG) publishes documents in below categories.
Below are some of the critical MDCG Documents published up to now.
MDCG 2023-5 Guidance on qualification and classification of Annex XVI products – A guide for manufacturers and notified bodies
Q&A Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR
MDCG 2021-24 Guidance on classification of medical devices
MDCG 2024-10 Clinical evaluation of orphan medical devices
MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices
MDCG 2021-12 rev.1 FAQ on the European Medical Device Nomenclature (EMDN)
MDCG 2022-7 Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU)
In order to reach MDCG documents please visit EU Commission Official Webpage
/health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_encurrent-guidance
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