On October 13 we organized the Briskr Validate! workshop ‘A pragmatic & practical approach to the new MDR for medical devices’ with Anja Wiersma from Mi-CE Consultancy.
Main question was: How to get your Medical Device on the EU market as soon as possible and remain in full compliance with the medical device regulation? Anja informed us on how to comply to the new MDR and IVDR. And what consequences these will have for registration of medical devices (a.o. classification changes of medical devices under the new MDR).
She also discussed the consequences of Brexit for medical devices and that some Notified Bodies will not be able to meet the new standards. All in all swift action is required. Manufacturers should contact their Notified Body as soon as possible and find out what they need to do to comply, have a strategy for regulatory compliance and gain all necessary documents.
Learn more in the recording of this webinar: