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.

Resources Archive

To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.

Functional Always active

The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.

Preferences

The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.

Statistics

The technical storage or access that is used exclusively for statistical purposes. The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.

Marketing

The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.

Regulatory Resources

2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization

2020 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease

2019 AHA/ACC/HRS Focused Update on Atrial Fibrillation

2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease

2018 AHA/ACC Guideline for Management of Adults With Congenital Heart Disease (superseded 2025)

2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Bradycardia and Cardiac Conduction Delay

2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for Prevention and Management of High Blood Pressure in Adults

AASLD/IDSA Recommendations for Treatment of Hepatitis C

AASLD/ACG Practice Guidance: Primary Biliary Cholangitis

AASLD Practice Guidelines: Management of Adult Patients with Ascites

Medical Device Navigator

Directory

Company

Content