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

1,129 resources

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

MDCG Guidance 2023-12 MDCG Guidance Other / Transition

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

MDCG Guidance 2023-01 MDCG Guidance Other / Transition

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

MDCG Guidance 2021-03 MDCG Guidance Other / Transition

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Regulatory Resources

TÜV SÜD — Biocompatibility Testing for Medical Devices: ISO 10993 Guide

TÜV SÜD — EU MDR Compliance: UDI, EUDAMED, and Economic Operator Obligations

BSI — Software as a Medical Device (SaMD) Classification and Certification

BSI — Clinical Evaluation Under EU MDR: Requirements and Best Practices

BSI — MDR Transition Guide for Medical Device Manufacturers

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

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

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

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

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

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