RT Journal Article SR Electronic T1 An essential ‘health check’ for all medical devices JF Clinical Medicine JO Clin Med FD Royal College of Physicians SP 543 OP 545 DO 10.7861/clinmedicine.3-6-543 VO 3 IS 6 A1 S Andrew Spencer A1 Sarah E Nicklin A1 Yapa A Wickramasinghe A1 Andy Nevill A1 Simon J Ellis YR 2003 UL http://www.rcpjournals.org/content/3/6/543.abstract AB In order to safeguard patient safety, all new or modified medical devices must be assessed for their safety and performance before they are used routinely in clinical practice. Most devices will carry a CE (Confirmity European) mark to demonstrate their safety, but many devices will require an alternative method of assessment. In this article, we discuss the procedures already in place, the significant gaps that exist in the system and the risk management issues. We consider the impact on research and clinical practice, and describe our comprehensive risk management system for objectively assessing the safety of any medical device.