Our team in GMRE expertise in creating a transition strategy for legacy devices. First of all, an initial readiness assessment is performed, which is then followed by a deep gap-analysis. These are crucial for pinpointing the regulatory compliance gaps between AIMDD/MDD and MDR, when coming to plan MDR transition for legacy devices
Selecting the appropriate Notified Body for your product
Preparation of Technical Files for all medical device classes
QMS – Procedures and forms to establish a robust quality system
PMS activities, including vigilance: reviewing & reporting incidents, field actions and adverse events
PMCF
Published in the Official Journal of the European Union in April 2017, the EU MDR
(Regulation EU 2017/745) was developed to reflect the significant progress in medical
device technologies that had taken place since the implementation of the EU’s initial
framework in the 1990s, and to harmonize the regulatory review and approval process
across all EU Member States. With the recently enforced MDR coming to replace the old AIMDD/MDD, multiple challenges arise.
