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.

Team NB Documents

Official documents from Team NB (Team of Notified Bodies), including position papers, guidance documents, white papers, and reference documents related to EU medical device regulations under MDR and IVDR.

50 resources

Position Paper: AI and Notified Body Designation

Position Paper 2022-12-16 Team NB Documents

Position paper on the designation of Notified Bodies for AI-based medical devices under EU MDR/IVDR.

Team NB Documents

Position Paper: AI and Notified Body Designation

Position Paper: Certificates Issued under Conditions

Position Paper: Interim Measures — Verification for Class D IVDs

Position Paper: Voluntary Transfer Agreement

Position Paper: Cybersecurity for Medical Devices

Position Paper: Off-Label Use of Medical Devices

Position Paper: Conformity Assessment of Multiplex Assays

Position Paper: Modifications to Sampling Plans

White Paper: One Year of MDR Application — Lessons Learned

Position Paper: IVDR Significant Changes (V1)

Position Paper: Article 117 Substantial Changes for Drug-Device Combinations

Position Paper: MDR/IVDR Implementation (V3)

Position Paper: Article 117 NB Opinion Template

Position Paper: Artificial Intelligence in Medical Devices (V1)

Position Paper: Implant Card Requirements

Position Paper: Class D IVD Conformity Assessment (V4.4)

CIRCABC Remote Audit Analysis (May 2021)

Position Paper: Article 117 Substantial Changes and Life Cycle Management

Position Paper: Remote Audits

Position Paper: Technical Change Plan (TCP)

List of Online Tools to Check Validity of NB Certificates

Position Paper: Documentation Requirements under Article 117

Position Paper: Dental Implants

Joint NB Spinal Implant Classification Decision Tree

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