Description: Until now, the requirements for a Technical File, or in the case of class III devices a Design Dossier, were expressed only in very general terms in the Medical Device Directives. The Medical Device Regulation goes further by detailing the required content of the Technical Documentation in Annex II, with the corresponding Annex III for the part of the Technical Documentation dedicated to the Post-Market Surveillance system, including the introduction of the Periodic Safety Update report (PSUR) or Post Market Surveillance Report according to Articles 86 and 85 respectively. In addition, it is now required to provide for each General Safety & Performance requirement the precise identity of the controlled documents offering evidence of conformity of the device. Under the MDD, the ER checklist could be filled in a much more general way. This session will explain to manufacturers the required content of the Technical Documentation as well as practical considerations for meeting the requirements. It will also consider the relationship between Annex III and the PMS process.
How to update the Technical Documentation according to Annex II of the MDR
Know different ways to fill in the GSPR checklist in a way acceptable for Notified Bodies.
Implement a process for Post Market Surveillance to meet the requirement of Annex III of the MDR