MDRQ #1723
MDRQ #1690: ANNEX I GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
MDRQ #1718: CHAPTER II REQUIREMENTS REGARDING DESIGN AND MANUFACTURE
MDRQ #1720: 10.1. Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance requirements referred to in Chapter I are fulfilled.
MDRQ #1721: Particular attention shall be paid to:
(b) the compatibility between the materials and substances used and biological tissues, cells and body fluids, taking account of the intended purpose of the device and, where relevant, absorption, distribution, metabolism and excretion;
Status:
Released
Priority:
Low
Description
(b) the compatibility between the materials and substances used and biological tissues, cells and body fluids, taking account of the intended purpose of the device and, where relevant, absorption, distribution, metabolism and excretion;