Results 3 found
August 26th, 2016
PRE-RECORDED WEBINAR: Broader Regulatory Oversight of In Vitro Diagnostic Devices: A Deep Dive into the changes to the EU IVD Regulations

The European Union has recently published the new IVD Regulations which are distinct and separate from the Medical Device Regulations. The revised IVD Regulations have been modified so extensively that it is estimated that whereas now 20% of IVD’s are under EU Regulatory control, when enacted, almost 80% of IVDs will be under regulatory control…. read more

June 1st, 2016
More time to wait until the EU MDR and IVDR are ready

The European Council has reached a political agreement on the proposed/draft Medical Devices and IVD Regulations. The press release, issued May 25th, 2016 marks the end of the wait of the question of when the restructuring that began in 2012 would be put into place. However, although agreement has been met, there are still some… read more

January 29th, 2014
UL’s Notified Body Toolkit

The EU is one of the most attractive markets for medical device and IVD sales. UL’s Notified Body toolkit provides 34- pages of information on the EU regulatory system, including the classification rules, process for approvals and conformity assessment procedures. It also is a valuable reference document, with links to guidance documents, Interpretive documents and… read more