Regulatory, quality and clinical affairs

MDCG Guidance - These guidance are endorsed by by the European Commission and provide relevant interpretation and guidance on how to apply Medical Device Regulation and In Vitro Diagnostic Regulation requirements

EPFL Standards - EPFL Library to access a wide range of European and international standards (ISO, IEC, ETC.)

Documents

MDCG Guidance on classification of medical devices - This document helps at identifying what is the applicable risk class for a medical device (i.e. Class I, IIa, IIb & III)

Borderline Manual - This document helps at qualifying medical devices which are borderline between medical devices regulation, pharma regulation, cosmetic regulations, etc.

Design Control guidance for Medical Device Manufactures - FDA Guidance that outlines medical devices principles

Implementation of risk management principles and activities within a Quality Management System - This document helps medical device manufacturers integrate risk management into their quality management system with practical explanations and examples.

MEDDEV 2.7/1 rev 4 Clinical Evaluation : A guide for manufacturer and Notified Bodies under directives 93/42/EEC and 90/385/EEC - This document provides a methodology to perform a clinical evaluation, including a literature search. Note this document contains some concepts which are now obsolete/incomplete and should be used in conjunction with MDCG guidance relevant to clinical evaluation.