The state of the art evaluation is a necessary component of Clinical Literature Evaluations (CERs) based on the European Union (EU) Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and current regulatory guidance.
There is the expectation under current European Union (EU) regulations that the state of the art evaluation, part of Clinical Literature Evaluations (CLEs), contains similar device data, among other information. Similar devices are devices that have the same or similar intended purpose as the device(s) under assessment. Information in the state of the art evaluation regarding similar devices must also be consist with manufacturers’ internal documentation.
This article defines similar devices and best practices for similar device data included in state of the art evaluations and CERs under EU regulations. Read the article here.
The article is free!
Simply fill in the form below, verify your email address
and you’ll be sent a link to download the article.
Related Posts
- 78Have you struggled to develop your search strategies for the state of the art evaluation? Are you finding yourself sorting through large amounts of data? This article outlines best practices for creating the state of the art evaluation under EU regulations. Access the article here.
- 64By Richard Conforti, M.S., Nerac Analyst, Originally Published: April 19, 2016 In 2014 the Chinese Food and Drug Administration, CFDA, updated their regulations on medical devices. These updates substantially changed the way in which a medical device company, particularly international companies not based or founded in China, registers their devices in China. In part 1…
- 64By Ron Sills, Nerac Analyst, and Donna Mitchell-Magaldi, Nerac Analyst Originally Published: September 26th, 2014 In 2009, the European Commission released MedDev 2.7.1 Rev.3 “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies” as a supplement to the requirements of the EU Medical Device Directive 93/42/EEC. In order for medical devices to be marketed in…