TY - JOUR T1 - An essential ‘health check’ for all medical devices JF - Clinical Medicine JO - Clin Med SP - 543 LP - 545 DO - 10.7861/clinmedicine.3-6-543 VL - 3 IS - 6 AU - S Andrew Spencer AU - Sarah E Nicklin AU - Yapa A Wickramasinghe AU - Andy Nevill AU - Simon J Ellis Y1 - 2003/11/01 UR - http://www.rcpjournals.org/content/3/6/543.abstract N2 - 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. ER -