From 27 May 2024, the MDR will be fully applicable to all medical devices. As also noticed by MDCG 2022-11, manufacturers are responsible to ensure that their devices comply with the MDR as from the end of the transition period. From that date, medical devices not certified under the MDR will have no access to the EU market.

According to the MDR, manufacturers, in cooperation with other economic operators, are required not only to reactively assess the safety and performance of their devices, but also to play an active role by systemically and actively gathering, recording, and analysing relevant data on the quality, performance and safety of a medical device throughout its entire lifetime. Indeed, reliance solely on complaints and vigilance to demonstrate the conformity to the relevant GSPR is not sufficient even for those devices which are well- established technologies and surveys are recognized as planned proactive post-market surveillance activities for data collection.

To support medical device manufacturers, 1MED introduces 1SURVEY, the Real World Data collection tool.

1MED can support you with the design, implementation, distribution, data management and reporting phase of the survey. Our professional guidance and expertise is at full disposal to implement this strategic tool and help you remain competitive with your medical devices on the market.

Make sure you have everything in place to be compliant with the MDR, today: start collecting realworld data for your medical device with 1Survey!