Open AccessMedical devices industry: the problem of clinical evaluation reports
Author(s) -
David Egbosimba
Publication year - 2019
Publication title -
annales de biologie clinique
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.167
H-Index - 27
eISSN - 1950-6112
pISSN - 0003-3898
DOI - 10.1684/abc.2019.1473
Subject(s) - scrutiny , medical device , documentation , business , scope (computer science) , compliance (psychology) , product (mathematics) , portfolio , risk analysis (engineering) , european union , process (computing) , authorization , order (exchange) , medical emergency , medicine , law , computer science , computer security , finance , political science , psychology , social psychology , geometry , mathematics , biomedical engineering , economic policy , programming language , operating system
In order to achieve regulatory compliance and acquire authorisation for sale in Europe, each medical device must be supported by a clinical evaluation report (CER) which documents the clinical evaluation process in its entirety. This is not a new requirement but highly publicised scandals caused by defective medical devices increased scrutiny of notified bodies (the organisations designated by the European Union to evaluate medical device compliance) meaning they are more liable and must strengthen their inspections of medical device manufacturers. Manufacturers are already under increased pressure due to the new EU Medical device regulation published in 2017. The scope of the new regulation requires many manufacturers to evaluate the documentation for their whole product portfolio. CERs are an important part of regulatory compliance and are also one of the biggest challenges for manufacturers who do not have sufficient resources and do not dedicate enough time to this task. This article examines the background of this requirement while offering medical device manufacturers advice for successful clinical evaluation reports.