The MDR was adopted by the European Parliament and the Council of the European Union in April 2017 and replaced the previous Medical Devices Directive (MDD). The transition period for the MDR was initially set to end in May 2020, but due to challenges faced by the industry and the COVID-19 pandemic, the European Commission postponed its application to May 26, 2021. To avoid a real and imminent risk of shortages of devices on the EU market and to provide additional time for manufacturers to adapt to the new regulatory requirements, the European Commission recently adopted Regulation (EU) 2023/607, extending the transitional provisions in Regulation (EU) 2017/745 (the 'MDR') to 2027 (specific circumstances) and removing the sell-off period in the MDR and Regulation (EU) 2017/746 (the 'IVDR') (Apr 3, 2023). By the last day of 2027, over half of a million medical devices currently approved for sale in the European Union will need to have achieved recertification of compliance the MDR. As part of the re-certification process and depending on their risk class  the device manufacturers will need to either demonstrate safety and performance of their products using real world data collected as part of their routine medical use and/or demonstrate safety and performance using data generated in clinical investigations. This white paper outlines how the looming challenge of re-certifying medical devices in the EU can be navigated. It also provides access to the resources the MedTech Alliance, consortium created for this purpose by experts providing complementary services GCP-Service, Gouya Insights, and of CSOFT Health Sciences, collectively offering a one-stop-shop to manufacturers of medical devices, particularly those of devices of higher risk categories required to collect additional real world data and/or conduct clinical testing of their devices. To learn more about MedTech Alliance and how it may help you getting your medical devices certified/ re-certified in the EU send an inquiry to medalliance@csoftintl.com