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

5 resources

Joint replacement (primary): hip, knee and shoulder

Clinical Guideline 2020-06-04 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Surgery & Orthopaedics (2020).

Download PDF

Jaundice in newborn babies under 28 days

Clinical Guideline 2010-05-19 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Women's Health & Obstetrics (2010).

Download PDF

Japan PMD Act — Pharmaceuticals and Medical Devices Act

Regulation 2014-11-25 Japan (PMDA) Regulations

The Japanese law governing quality, efficacy and safety of pharmaceuticals and medical devices. Regulated by MHLW and PMDA. Major revisions in 2014, 2019, and 2022.

Download PDF