Medical Device Network

1MED prepares to unveil EU MDR compliance software

The 1MED Compliance Pack is designed to facilitate the recertification process for medical device companies as required by the new European MDR.

Contract research organisation, 1MED is planning to unveil a recertification compliance software, MED Compliance Pack, to help companies comply with the European Medical Device Regulation (EU MDR).

The company said it will showcase the software at the 12th Annual Outsourcing in Clinical Trials: Medical Devices Europe Conference taking place in Munich, Germany, on 30-31 January.

The EU MDR becomes fully applicable to all medical devices from 27 May. Medical device companies are required to submit their legacy devices for recertification by 26 May and must sign an agreement with a notified body by 26 September.

1MED’s Compliance pack identifies documentation gaps, streamlines the submission process to notified bodies and simplifies compliance with the EU MDR's standards. Thereby, facilitating the recertification process for medical device companies. The company also provides support in drafting all necessary clinical, technical, and quality documentation to ensure compliance with the EU MDR.

The average time from device conception to approval is approximately three to seven years. The World Health Organization (WHO) estimates that there are around two million different medical devices currently on the market, and these are increasing exponentially.

Along with the compliance tool, the company plans to introduce a real-world data collection tool, 1SURVEY. The platform allows companies to create dedicated questionnaires and gather clinically relevant information on their medical devices.

The use of technology, especially artificial intelligence (AI) has been increasing in recent years. The AI market is expected to reach sales of $93bn in 2023, according to GlobalData forecasts.

Another company that has developed a medical compliance tool is AND Technology Research. In October 2023, the company added an AI update to Tento+ to streamline the medical compliance process. According to AND Technology, the Tento+ AI can save around 236 hours per submission. The users enter a brief description of the device, and the tool then generates the device design standards and automated checklists. The software also provides design requirements and test plan suggestions along with tailored insights into these fields.