1MED unveils how to navigate 2024 MDR at Outsourcing in Clinical Trials Europe

1MED, a Contract Research Organisation providing clinical and regulatory support to medical devices companies, is participating as a sponsor and exhibitor at the 12th Annual Outsourcing in Clinical Trials: Medical Devices Europe Conference in Munich.

As the Medical Device Regulation (MDR) becomes fully applicable to all medical devices from 27th May 2024, 1MED is set to showcase solutions to support MedTech companies in meeting crucial 2024 MDR deadlines.

At the heart of 1MED's offerings is the 1MED Compliance Pack, a tool designed to facilitate the recertification process for medical device companies. This tool identifies documentation gaps, streamlining the submission process to Notified Bodies and simplifying compliance with the MDR's standards.

Additionally, 1MED introduces 1SURVEY, a Real-World Data collection tool. The digital platform redefines post-market data collection, empowering medical device manufacturers to make informed, data-driven decisions and improve patient care through proactive measures. From generating dedicated questionnaires to seamless digital implementation, 1SURVEY provides a smart, user-friendly solution for gathering clinically relevant information on medical devices.

1MED founder Enrico Perfler said: “This two-day event is a golden opportunity for the European MedTech and Diagnostics community to gain fresh insights into regulatory changes and strategies to tackle them. At 1MED, our journey in MedTech is marked by deep expertise and a commitment to innovation. We look forward to showcasing the valuable assistance we can offer to help companies navigate and overcome the complexities of the new regulatory framework.”

The year 2024 is pivotal for the MedTech sector, with critical deadlines for the recertification of legacy devices under the new MDR. By 26th May 2024, companies must have submitted their legacy devices for recertification, and by 26th September 2024, they must sign an agreement with a Notified Body.

With these impending deadlines, the 1MED Team provides expert support to help manufacturers develop and optimise their regulatory strategy. The 1MED team offers comprehensive support in drafting all necessary clinical, technical, and quality documentation to ensure compliance with the MDR.

With the 1MED Compliance Pack, 1MED provides tailored support to manufacturers. This ensures smooth and successful MDR application submissions to Notified Bodies, mitigating the risk of missing the critical May 26th, 2024, deadline.