European DIGICAP project aims to digitalise medical device certification

Stricter European regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR) have strengthened patient safety, but have also made certification procedures considerably more complex. Today, certification takes an average of 13 to 18 months.

The current certification process involves exchanging large volumes of documents, manually completed forms, PDFs and Excel files. This can result in incomplete submissions, delays and uncertainty about lead times. SMEs in particular are affected, potentially delaying patients’ access to new medical technologies.
 

DIGICAP

Coordinated by Team-NB, the European Association of Notified Bodies for Medical Devices, DIGICAP aims to move away from a predominantly document-based process towards a standardised, machine-readable and interoperable digital approach.

Among other things, the project will develop open standards for data exchange and standardised interfaces that can be integrated with existing quality and regulatory management systems. It will also explore how AI and automation, under human supervision, can support the preparation of technical documentation and help check the completeness of submissions before they are filed.

The new approach will be tested through real-world pilots involving notified bodies and manufacturers of medical devices, IVDs and software as a medical device. At least 80% of the participating manufacturers will be SMEs.

The ultimate goal is to develop a European roadmap for the large-scale digitalisation of conformity assessments, increasing predictability for manufacturers and notified bodies and, ultimately, enabling faster patient access to safe and innovative medical technologies.
 

Key role for VITO

“As Technical Lead of DIGICAP, VITO has an important role in developing and testing digital solutions that will enable medical devices and in vitro diagnostic medical devices to be assessed faster, more efficiently and more transparently,” explains Bart Elen of VITO.

“To achieve this, we are working closely with the European health technology industry and certification bodies. Together, we are developing new digital approaches to make the certification process under the MDR and IVDR simpler and faster.”

“VITO will also provide a controlled testing environment in which the new solutions can be tested and evaluated under realistic conditions. The knowledge and experience gained by VITO will be translated into practical guidelines and digital tools. In this way, VITO is helping to shape a future-proof and more harmonised European approach to assessing medical technologies.”
 

Pan-European collaboration

The DIGICAP consortium brings together expertise from 10 EU Member States, with broad representation from notified bodies, industry, and technical and scientific organisations:

• 11 notified bodies, including both public and private organisations and both large and smaller players.
• Industry and data experts: MedTech Europe and the Medical Device Knowledge Units (MDKU) Foundation.
• Technical and scientific research organisations: RISE, which also hosts the European Union Reference Laboratory (EURL) for IVDs, and VITO, which is responsible for technical coordination.
• Experts in law, project management and public health: AXON Lawyers, Matical Innovation and the European Public Health Association (EUPHA).

The three-year project receives €4 million in funding through Horizon Europe and brings together 19 European partners.