Medical Device Obligations Taskforce (MDOT)

Medical Device Conformity Process 

Project Description: 

MDOT is a cross-organizational workflow digitalization project regarding the European medical device conformity process. This is the process which new medical devices must go through to prove compliance to regulation and market standards with the purpose to ensure quality and safety of medical devices circulated on the market. 

The legal regulations on which the project is based on is a new regulatory framework for medical devices, Medical Device Regulation/MDR (EU 2017/745) and was first published in 2017 to replace EU regulation on medical devices/MDD (Council Directive 93/42/EEC) and active implantable medical devices/AIMD (Council Directive 90/385/EEC). Not only does MDR replace MDD and AIMD but is an "upgrade" to be more inclusive and stricter on the regulation of medical devices. 

The primary objective of the MDOT consortium is to prevent regulatory pressure from hampering innovation and competitiveness of Europe's MedTech SMEs. From leveraging the use of digital technologies, we hope to lubricate the release of innovative medical devices on the market by allowing MedTech SMEs to effectively prove clinical equivalence of comparative products. 

 From preliminary investigation of the medical device conformity process in the context of SMEs, we have identified 4 major problem areas that can be improved upon: 

·       Complex Interorganizational Workflows 

·       Knowledge Gap of SMEs 

·       Long Product Conformity Testing Lead Time 

·       High-Cost Burden for SMEs 

The consortium's proposal is to create a digital platform in which various participants to the medical device conformity process can coordinate workflows and securely share information. 

We as the FINATRAX team will collect use cases and create the high-level design. We will then go on to implement the technical solution and document the testing of it.