Question 1

What is an MDCG guidance document?

Accepted Answer

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.

Question 2

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

Accepted Answer

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.

Question 3

What is a Team NB document?

Accepted Answer

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.

Question 4

What clinical guidelines are available on Medical Device Navigator?

Accepted Answer

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.

Borderline and Classification

Helsinki Procedure: Helsinki Procedure for borderline and classification under MDR & IVDR

MDCG 2022-5: Guidance on borderline between medical devices and medicinal products under MDR

MDCG 2021-24: Guidance on classification of medical devices

Manual on Borderline v4: Manual on borderline and classification under Regulations 2017/745 and 2017/746

MDCG 2024-13: Regulatory status of ethylene oxide (EtO) for sterilisation of medical devices

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