Update: Proposed European Union Medical Device Regulations
Raise your awareness of the current state of the proposed EU Medical Devices Regulation
(MDR) by hearing chapter by chapter and what's likely to be in the MDR basis and
how this will likely impact manufacturers.
On September 26, 2012 the EU Commission released its proposal for future regulation of
medical devices. Within the proposal, the current three Directives on active implantable
medical devices (AIMD), medical devices (MDD) as well as in vitro diagnostic medical
devices (IVDD) are replaced by two Regulations, one covering all medical devices, the
other covering IVDs. Both regulations are in the final stages of the legislative
procedure and are expected to be finalized sometime in 2016, allowing them to come into
effect by the end of 2016, or early 2017.
What will companies need to be aware, and when will changes impact them? All medical
device manufacturers must plan and prepare for the new regulations because EU law does
not allow grandfathering of devices, so every device manufacturers must comply with the
new requirements aligned with the transitional time frames proposed.
This webinar will help you to consider what actions you need to start now to be prepared
for the change in requirements; the webinar will outline the new requirements so that
medical device manufacturers can start planning their resources to ensure uninterrupted
CE Marking and EU market access during and after the transitional period of the new
Please note this webinar will not cover IVD's, but we will publish a follow up for
Paul Brooks, Senior Vice President Healthcare Solutions, leads the
Healthcare sector in the Americas for BSI. Paul was the Head of the Notified Body for
BSI's Medical Devices Group from 1998 to 2002 during which time he represented BSI
at meetings in Brussels with the European Commission.
Mr. Brooks is responsible for leading BSI's medical device business in the
Americas, including CE Marking Programs and interfacing with U.S. FDA and Health Canada.
Paul is a long standing member of RAPS and American Society for Quality Biomedical
Division, Paul served on Board of RAPS for 6 years serving as Chairman in 2013.