The PMS requirements of the Medical Device Regulation (MDR) apply to all manufacturers of medical devices from May 2020, even those who continue to place legacy devices on the market (devices certified under the AIMDD or MDD). However, because the implementation of Eudamed (the European database) has been postponed, all medical devices will continue to be subject to some of the provisions of the directives, including those that have achieved CE marking under the new Regulation.
Using a combination of theory and practical case studies, this course will clarify the transition of old requirements to new ones and will allow delegates to develop the knowledge needed to build successful PMS strategies and understand the latest requirements and technologies for reporting vigilance.
Mika has a Master’s degree in Law from the University of Nice and later gained a Master’s in Business Administration from the Wharton School.
He has more than 30 years of experience managing European medical regulatory affairs in industry, as a healthcare legal counsel and as a regulatory consultant. He has also been involved directly in the development of the Medical Devices Directives and of technical standards since the 1990s.
He founded the medical device consulting company Abnovo Ltd in 2007 to provide a wide variety of networked services to the medical device industry worldwide.
He is currently a member of various medical device expert working groups of the European Commission and is Chairman of the European Association of Authorised Representatives (EAAR).
This course is relevant to medical device and IVD regulatory affairs professionals who wish to develop their understanding of PMS and vigilance:
The interaction with the trainer and other participants with a focus on practical exercises was very useful.
The depth of knowledge of the presenter and breadth covered in the course was excellent.
I enjoyed all the examples given during the presentation as well as the vigilance content and information/experience shared between attendees.