Digitalization as the key to future development of MDR and IVDR

Michael M. Kania
September 12, 2023
Medical Device Regulation

The recently published white paper by BVMed and VDGH has caused a lot of discussion in the medtech industry. Among other things, it calls for the abolition of recertification and a fast-track procedure for innovations. We at think this is an important step in the right direction and would like to share our view on the role of digitization in this context.

More than PDF and XML: the need for digitization

The proposal to use the pharmaceutical industry as a model with the eCTD is a good idea, but it can only be the beginning. The management of the eCTD is far from the automation that is possible today. The endpoints as PDFs are no help in the review process. On the one hand, there is the manufacturer who has to create the document, and on the other hand, there is the reviewer who has to extract the content for his review report.

We need a complete digital transformation that includes cloud technologies and AI-driven analytics to streamline the regulatory process. We are talking about complete standardization and automation of processes. Our research has shown that the efficiency of manufacturers can be significantly increased through digitalization.

Standardization: The key to true digitalization

Given that 93 percent of German medical technology companies are SMEs, it is obvious that individual solutions cannot be the right way forward, if only for economic reasons.

More than just a buzzword, standardization is the foundation for true digitization and interoperability. Standardized data formats and interfaces enable automated processes and data-driven decisions. This paves the way for efficient and transparent communication between different systems and stakeholders. Especially in the context of the conformity assessment process, standardization brings significant benefits by reducing the burden on both manufacturers and Notified Bodies.

Here it becomes clear that a standardized document structure is only the beginning. The real benefits, and an efficient increase in speed, are only possible with content-based technical documentation. Our research shows that digitization is already leading to significant efficiency gains on the manufacturer side. It is time for Notified Bodies to follow suit.

The untapped potential: removing bottlenecks through digitization

The white paper highlights that the current EU MDR and IVDR regulations are slowing down innovation and creating bottlenecks for medical devices. At the same time, it shows that manufacturers who have ventured into digitalization are already achieving success, while Notified Bodies are lagging behind. This combination creates significant bottlenecks and leaves much potential untapped. Digitized conformity assessment could be a building block to effectively remove these bottlenecks and increase the efficiency of the entire system, ultimately benefiting the entire industry and patients.

What's next.

The BVMed and VDGH white paper is an important milestone for the further development of MDR and IVDR. We believe that digitalization can and should play a key role in this evolution. By combining regulatory improvements and digital innovations, we can create a more efficient and safer medtech landscape. We have been researching and developing the topic of eTD since 2018. The potential is huge. The evidence is there.

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