Results 5 found
November 29th, 2016
New EU IVD Regulations Webisode Series

With the upcoming EU regulatory changes for IVDs, it’s important to keep informed about the changes so you can prepare your business. We know your time is important and sometimes there are only a few minutes between meetings to catch up on information that is important to you and your business. That’s why we have… read more

October 14th, 2016
PRE-RECORDED WEBINAR: Business Impact of the new EU IVD Regulation – An Executive Brief with Sue Spencer

About this webinar: In this 30-minute pre-recorded webinar, Head of UL Global Medical Device Services, Sue Spencer shares her expertise in what to expect from a business standpoint for the new EU IVD Regulations. The European Union IVD “revolution” has been in motion since 2012. Many of the larger companies are already putting the systems… read more

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 17th, 2016
Business Impact of the new EU IVD Regulation – An Executive Brief with Sue Spencer

The European Union IVD “revolution” has been in motion since 2012.  Many of the larger companies are already putting the systems and requirements in place to prevent any interruption of business as we are now in final stages of  finalizing through the EU Legislative process and expect the transition phase to begin as early as… 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