Medical device companies will need to adapt to the Medical Device Regulations (MDR), which come into force by May 2020. The new Regulations promote a full life-cycle approach impacting Regulators, Notified Bodies as well as Medical Device Manufacturers. The new Regulations include new features and requirements, with far more detail than the old medical device directives. As MDR can impose risks your business continuation, Medical Device companies are advised to know the implications and start preparations on time.
In Part I of a two-part series, Acolad’s guest presenters, Professor Herman Pieterse, Professor in Clinical Pharmacology at the University of Ghent explains on a high-level what the new regulations mean and provide you with insights on its business impact. The provided insights will allow you to understand the most important changes and when they will become effective along with benefits to help you understand how and when to prepare.
Questions relating to your day-to-day business will be addressed, including:
✔ Should we re-certify under MDD or under MDR?
✔ Will we be able to stay with our current Notified Body?
✔ How do we know if we are ready for certification under MDR?
Webinar series key learning objectives: