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.

MDCG Guidance Archives

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MDCG Guidance

EU IVDR — In Vitro Diagnostic Regulation (EU) 2017/746 — Official Full Text

EU MDR — Medical Device Regulation (EU) 2017/745 — Official Full Text

MDCG 2023-1: Guidance on the health institution exemption under Article 5(5) of MDR and IVDR

MDCG 2019-7: Guidance on Article 15 – person responsible for regulatory compliance

MDCG 2022-11: Notice to manufacturers to ensure timely MDR/IVDR compliance

MDCG 2021-3: Questions and Answers on Custom-Made Devices

MDCG 2021-25: Application of MDR requirements to legacy devices placed on market prior to 26 May 2021

MDCG 2020-3: Guidance on significant changes regarding transitional provision under Article 120 of MDR

MDCG 2021-5: Guidance on standardisation for medical devices

MDCG 2022-4: Guidance on appropriate surveillance regarding transitional provisions under Article 120 of MDR

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

MDCG 2019-11: Qualification and classification of software under MDR & IVDR

MDCG 2025-10: Guidance on post-market surveillance of medical devices and IVDs

MDCG 2019-16: Guidance on cybersecurity for medical devices

MDCG 2020-1: Guidance on clinical/performance evaluation of medical device software

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