ARTICLE SUMMARY:
In this month’s spotlight from Pathways’ Document Depot: EU organizations, including the European Commission and TEAM-NB, rolled out resources and arguments engaging with the recently extended Medical Device Regulation transition.
Implementing the Medical Device Regulation (MDR) has been a frantic game of catch-up for the past six years or so. That still remains the case in many ways. But the urgency dialed down several notches earlier this year when the EU approved a substantive extension to the period of time devices that are certified under the legacy EU medical device directives have to transition to the new regulation.
Several documents published in July and August underscore that the EU regulatory system has shifted significant focus toward ensuring appropriate adoption of the new flexibilities and that the system takes full advantage of the extra time.
