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.

MDR

BSI — Post-Market Surveillance and Vigilance Under EU MDR

SGS — EU MDR Readiness Guide: Technical Documentation and Common Non-Conformities

DNV — EU MDR Compliance: Person Responsible for Regulatory Compliance (PRRC)

TÜV SÜD — EU MDR Compliance: UDI, EUDAMED, and Economic Operator Obligations

BSI — MDR Transition Guide for Medical Device Manufacturers

BSI — Clinical Evaluation Under EU MDR: Requirements and Best Practices

BSI — Software as a Medical Device (SaMD) Classification and Certification

EU MDR — Medical Device Regulation (EU) 2017/745 — Official Full Text

Medical Device Navigator

Directory

Company

Content