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

23 resources

Urinary incontinence and pelvic organ prolapse in women: management

Clinical Guideline 2019-04-02 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Women's Health & Obstetrics (2019).

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UK Medical Devices Regulations 2002 (SI 2002/618)

Regulation 2002-01-01 Regulations UK (MHRA)

The core UK medical device legislation as amended post-Brexit. Governs placing devices on the Great Britain market under MHRA oversight. New UK MDR framework under development.

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