Are you a manufacturer of medical device software (MDSW)? Then this webinar will give you an insight into the impact of the MDR on the qualification and classification of MDSW under the MDR. Is your device up classified, and if so, can you make use of any transition provisions following from the MDR? This webinar will also be beneficial for importers, distributors and users of MDSW, to be able to evaluate if you can still market or purchase this MDSW as of May 26, the date of application of the MDR.
During this webinar, Emergo will touch on the major differences between MDD and MDR in regard to MDSW. And which preconditions need to be met in order to keep marketing MDSW after the date of application of the MDR. Sign up here for FREE
What is it about?
The MDR has a significant impact on the qualification and classification of MDSW. As under the MDD, the vast majority of MDSW is Class I self-certified, the MDR will lead to up-classification of many of these devices. What is the reason for this, and how can you (last minute) anticipate to ensure business continuation. Emergo will give a high-level overview of some of the new requirements under MDR and the transition provisions. We will end the session with a short Q&A.
About the speaker: Annette van Raamsdonk (Emergo)
Van Raamsdonk gained significant experience with a broad variety of medical devices working at TÜV Rheinland and serving as Inspector of Medical Technology at the Dutch Health and Youth Care Inspectorate (IGJ). She represented the IGJ within the European Competent Authorities working group for Compliance and Enforcement and is currently main contact person towards European Competent Authorities. Areas of expertise include European medical device legislation, borderline issues, classification of medical devices and Competent Authority supervision. Over the past years, van Raamsdonk has been intensively involved in the implementation of the MDR and IVDR and contributed to European guidance documents (among others PMS guidance and Annex XVI Common Specification) on the MDR. She also participates in several EU working groups of the EC and national working groups.
After this webinar, you will know…
- What your role under the MDR is
- What your obligations are under the MDR as a Dutch manufacturer/importer/distributor of medical devices
- Why and how you need to co-operate with other EOs
When and where?
This webinar will take place on May 19, from 09.00 – 11.00 AM. We will host it on Remo, a user-friendly virtual meeting space.
Register for free
Join our webinar on MDSW under the MDR: sign up here for FREE