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.

Standards Archives

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Standards

IEC 60601-1:2005/AMD2:2020 — Medical electrical equipment — Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2014/AMD1:2020 — Medical electrical equipment — Part 1-2: Electromagnetic disturbances — Requirements and tests

ISO 10993-17:2023 — Biological evaluation — Part 17: Toxicological risk assessment of medical device constituents

ISO 10993-18:2020 — Biological evaluation — Part 18: Chemical characterization of medical device materials

ISO 10993-10:2021 — Biological evaluation — Part 10: Tests for skin sensitization

ISO 10993-11:2017 — Biological evaluation — Part 11: Tests for systemic toxicity

ISO 10993-6:2016 — Biological evaluation — Part 6: Tests for local effects after implantation

ISO 10993-4:2017 — Biological evaluation — Part 4: Selection of tests for interactions with blood

ISO 10993-5:2009 — Biological evaluation — Part 5: Tests for in vitro cytotoxicity

ISO 10993-1:2018 — Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

ISO 10993-3:2014 — Biological evaluation — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

ISO 14155:2020 — Clinical investigation of medical devices for human subjects — Good clinical practice

IEC 81001-5-1:2021 — Health software and health IT systems safety, effectiveness and security — Part 5-1: Security

IEC 82304-1:2016 — Health software — Part 1: General requirements for product safety

IEC 62304:2006/AMD1:2015 — Medical device software — Software life cycle processes

IEC 62366-1:2015/AMD1:2020 — Medical devices — Application of usability engineering to medical devices

ISO 14971:2019 — Medical devices — Application of risk management to medical devices

ISO/TR 24971:2020 — Medical devices — Guidance on the application of ISO 14971

ISO 13485:2016 — Medical devices — Quality management systems — Requirements for regulatory purposes

Intertek — Usability Engineering for Medical Devices: IEC 62366

Eurofins — Extractables and Leachables Testing for Medical Devices

SGS — Biocompatibility and Chemical Characterization for Medical Devices

Dekra — Quality Management System for Medical Devices: ISO 13485:2016

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

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