29 January 2018
Gert Bos from Qserve
846 days will be left of the transition period after you’ve listened to this webinar, in which we will indicate why some of the changes in the EU-MDR are fundamental in nature. 846 days seems to be a lot, but if we discount weekends and holidays, there are just around 500 days left. And compared to the estimates I’ve seen for implementations plans, 500 days is not a lot to get it all done. So, we need to get going and start the implementation.The webinar we’ll host will help you understand what key elements you should focus on in your implementation. It will highlight some of the essential changes, especially those that largely change the way we operate.
There is no patience in the system anymore, and EU-MDR is similarly to MDSAP expecting the first-time-right compliance, or in case of deficiencies at least not repeat offenses. Notified bodies are shifting from conformity assessment to compliance auditing. Guidance is hardly available, and when it comes, it will be mandatory in nature.
So it is not just some added lines of text in the articles of the law, and more detail in the annex I safety and performance principles. Hidden behind the details are new insights, new expectations from authorities supervising the market in their prospective active market surveillance activities, reviewing the strictness of the notified bodies in their assessments, and closely watching vigilance follow up by manufacturers.
As such, the webinar will not only focus on the EU-MDR details but also on how to run compliance improvement programms
in general, as much of what needs fixing for the revised European legislation is not only specific to the EU legislation but also follows the global trend of changing from conformity reviews to compliance assessments. As top up, some latest news from Brussels developments will be shared. It will be possible to post questions in the chat, and as long as time allows we will answer where we can. Further answers will be provided after the webinar in case we run out of time.
Join us, as life is too short not to have fun!
Stefan and Gert