CE Mark News for 2017
Are you tired of hearing that the new Medical Device Regulation (MDR) is coming?
In 2007 the initial talks started and in 2012 the first proposal, was taken apart by the Parliament due to the impact of the scandals evolving in 2010. In 2015 the Council issued its proposal! The trilog (Council Parliament and Commission) produced quite a bit of discussions and other stakeholders were trying to influence the last talks.
Finally in June 2016 the so-called political agreement was reached. It was an unfinished document that was translated but needed significant improvements and a final legal review. Now, just a few weeks ago, a so-called technical agreement was reached.
Now, is it coming? → YES, anytime soon!
Our timing is perfect for our tailor made In-House Workshop - The "NEW CE" mark for Medical Devices - and we are thrilled to present the outcome on the MDR, which are related to our services.
Responsibilities are bestowed upon the Importer and the Distributor also to check the manufacturers. The manufacturer should be aware of the impact it may have on marketing.
Post Market Surveillance as described is a new concept. Is reporting required already when you implement corrective action within your company if the information is derived from PMS data? Learn how the PMS data is being utilized and even your NB is being monitored and scrutinized with your data!
The evaluations a manufacturer and the authorities must apply in case of a serious incident have been increased and the timeline for reporting is reduced for the manufacturer. We will have to watch the penalties on a national level if manufacturers do not report on time.
Cooperation is required among Member States and the exchange of data will enable the authority to effectively scrutinize the manufacturer Europe wide. The manufacturer must know its remedies!
Suggested Workshop Topics:
- Draft - New Medical Devices Regulation Introduction 1 day
- Draft - New In Vitro Medical Device Regulation Introduction 1 day
- Draft - Post market Surveillance and Vigilance requirements ½ day
- Draft - Conformity Assessment and Technical documentation ½ day
- Current national registration requirements - Europe ⅓ day
Please contact us for further information, we will immediately provide further details.
Train your whole team with our tailor-made In-House workshops and make sure you are ready to survive and thrive!
Your MDSS Team