Learning Marketplace

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 regulation.

Please note this webinar will not cover IVD's, but we will publish a follow up for IVD products.


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.