Regulatory Compliance
Automate and standardize your regulatory management, from correspondence and commitments to registration and tracking.
White Paper
MDR: Extension of Transitional Provisions
Jul 24, 2023
On February 16, 2023, the European Parliament adopted legislation that amends the transitional provisions of the European Union (EU) Medical Devices Regulation (MDR) and removes the sell-off provisions in the MDR and the In Vitro Medical Devices Regulation (IVDR).
In this white paper, we consider the impact of the second major amendment to the EU Medical Device Regulation (MDR) to extend the transitional provisions. Manufacturers may have more time to comply, but conditions apply. We review the conditions and then also take a look at the status of other provisions to support MDR implementation.
Related solutions
Safety & Regulatory Compliance
Meet the challenge of changing stakeholder demands and increasing cost constraints with IQVIA's integrated technology services and analytics-driven offerings.