The BFCC aim is to establish a hospital-industry collaboration platform along the innovation cycle within fracture management. Optimised high quality collaboration standards shall match the companies' requirements for accelerated research and innovation.
The project risk assessment clearly earmarked a potential risk of changes in rules and regulations. This has now become reality: the new Medical Device Regulation (MDR) has come into place making alterations necessary to achieve a meaningful outcome for both clinicians and manufacturers. Clinics have to assure a constant monitoring of complications and irregularities occurring during the treatment. Manufacturers need to trace medical products even after a CE marking has been achieved.
In order to address the new requirements, a feasibility study (MDR addendum) has been embedded to the complications pilot. The goal of the feasibility is that specific implants can be traced and matched to corresponding adverse device related events, if they occur. Main partners involved are the University Medical Center Schleswig-Holstein on hospital side, Stryker Trauma GmbH as industry representative, and the University Medicine Greifswald as technical partner for implementing it into the registry.
The integration of MDR related activities into the current project setup further strengthens the link between industry and clinics, lays ground for future R&I collaboration and prepares the medical industry from the Baltic Sea Region (BSR) for the upcoming regulatory changes. The BFCC consortium compiles experts from the clinical side, data management and industry and, hence, is extremely well positioned to take on the MDR related challenges.
Key driver for adding the MDR feasibility study is the fact that the recently released MDR has replaced the EU’s current Medical Device Directive MEDDEV (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).
Besides other changes, the MDR newly regulates the classification of certain medical devices and renews the requirements for unique device identification (UDI) and reporting (e.g. Post Market Surveillance Plan/Report (PMS), Post Market Clinical Follow-up Report (PMCF), Periodic Safety Update Report (PSUR), and Summary of Safety and Clinical Performance (SSCP)). Additionally, the requirements for clinical data are uplifted with the consequence that more pre- and post-market clinical data will be needed for new and legacy products. All implantable class II and class III implant systems are in scope. Therefore, the MDR study supports the improvement of quality control in perfect amendment of the complication pilot.
Generating clinical trials requires time, resources and budget and, hence, the new regulation is a threat for small- and middle-sized entities but also for larger corporations, which usually have a large set of article numbers and systems on the market. To overcome this challenge, an effective way to generate clinical data needs to be developed. As the medical device industry will need to comply with the MDR latest by May 26th 2020, it is crucial to start preparation early.
If this feasibility study approach succeeds, it can be applied to many hospitals in the region. For the hospitals, an upscaling to other areas should be easy, so that also many different other registries can be handled this way, allowing significant reduction in labour used for data sampling at the moment.
- Pilot a feasibility with a system that:
- Understand and fulfil all related legal, ethical and data privacy requirements