What is an MDCG guidance document?

MDCG (Medical Device Coordination Group) guidance documents are non-binding technical guidance published by the European Commission to assist manufacturers, Notified Bodies, and competent authorities in implementing EU MDR 2017/745 and EU IVDR 2017/746. They cover clinical evaluation, post-market surveillance, UDI, EUDAMED, and other compliance topics.

What FDA guidance documents are required for a 510(k) submission?

FDA 510(k) submissions must follow applicable FDA guidance documents including the general 510(k) Guidance, device-specific guidances, and quality system regulation (21 CFR Part 820). Key documents include guidance on substantial equivalence determinations, cybersecurity pre-market requirements, and device-type-specific performance standards.

What is a Team NB document?

Team NB (Team of Notified Bodies) publishes position papers, recommendations, and guidance documents developed collaboratively by European Notified Bodies designated under EU MDR and IVDR. These documents clarify application of regulatory requirements and support harmonised conformity assessment practices across Notified Bodies.

What clinical guidelines are available on Medical Device Navigator?

Medical Device Navigator provides access to 700+ clinical guidelines and recommendations from major European and American medical societies including ESC, ESMO, EULAR, AHA/ACC, ASCO, ADA, NICE, and many more. Guidelines are organized by specialty and geographic scope (European vs American) to help medical device professionals understand clinical practice standards relevant to their devices.

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Regulatory Resources

MDCG 2019-9: Summary of safety and clinical performance

MDCG 2020-5: Guidance on clinical evaluation – Equivalence

MDCG 2020-6: Guidance on sufficient clinical evidence for legacy devices

MDCG 2020-8: Guidance on PMCF evaluation report template

MDCG 2020-7: Guidance on PMCF plan template

MDCG 2020-13: Clinical evaluation assessment report template

MDCG 2020-10/1: Guidance on safety reporting in clinical investigations

MDCG 2021-8: Clinical investigation application/notification documents

MDCG 2021-6: Q&A regarding clinical investigation under Regulation 2017/745

MDCG 2021-20: Instructions for generating CIV-ID for MDR Clinical Investigations

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