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.

Regulatory Resources

Clinical guidelines, MDCG guidance, FDA guidance, standards, and compliance tools

54 resources

MDCG 2024-12: CAPA plan assessment: guidance and templates for conformity assessment bodies

MDCG Guidance 2024-10 MDCG Guidance Notified Bodies

Download PDF

MDCG 2021-1: Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

MDCG Guidance 2021-05 EUDAMED MDCG Guidance

Download PDF

MDCG 2019-6: Q&A: Requirements relating to notified bodies

MDCG Guidance 2025-02 MDCG Guidance Notified Bodies

Download PDF

MDCG 2022-12: Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional (IVDR)

MDCG Guidance 2022-07 EUDAMED MDCG Guidance

Download PDF

MDCG 2021-19: Guidance note: integration of UDI within an organisation’s quality management system

MDCG Guidance 2021-07 MDCG Guidance UDI

Download PDF

MDCG 2018-1: Guidance on basic UDI-DI and changes to UDI-DI

MDCG Guidance 2021-04 MDCG Guidance UDI

Download PDF

MDCG 2022-21: Guidance on Periodic Safety Update Report (PSUR) under Regulation 2017/745

MDCG Guidance 2022-12 MDCG Guidance Post-Market Surveillance and Vigilance

Download PDF

Loading more resources…

Regulatory Resources

MDCG 2024-12: CAPA plan assessment: guidance and templates for conformity assessment bodies

MDCG 2021-1: Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

MDCG 2019-6: Q&A: Requirements relating to notified bodies

MDCG 2022-12: Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional (IVDR)

MDCG 2021-19: Guidance note: integration of UDI within an organisation’s quality management system

MDCG 2018-1: Guidance on basic UDI-DI and changes to UDI-DI

MDCG 2022-21: Guidance on Periodic Safety Update Report (PSUR) under Regulation 2017/745

MDCG 2022-7: Q&A on the Unique Device Identification system under MDR and IVDR

MDCG 2024-1: Device Specific Vigilance Guidance (DSVG) Template

MDCG 2023-3: Q&A on vigilance terms and concepts under MDR and IVDR

Medical Device Navigator

Directory

Company

Content