Not only for medical use, but also for clinical research with new medical equipment, software and apps, instruments and implants, from 26 May 2021 it will be mandatory to comply with the new European Legislation regarding medical devices, the Medical Device Regulation (MDR). A group of researchers from Erasmus MC, LUMC and TU Delft is taking the lead within Medical Delta and is investigating what that means in concrete terms for innovative medical technology.
This project is linked to the ‘Safe patient care through safe technology’ program of the Dutch Federation of University Medical Centers (NFU), which focuses on the implementation of the MDR. The group - consisting of researchers, clinicians, instrumentation makers and policy staff - started three pilot projects at the end of last year. They use this to investigate how scientific institutes can implement the new legislation.
Testing with people is an indispensable link in bringing technological solutions from the lab to the healthcare practice. Such examinations must be carried out carefully and require approval from the Medical Ethics Review Committee (METC). Because an innovative medical device does not yet have a CE mark, an ‘Investigational Medical Device Dossier’ (IMDD) must be submitted with the METC application.
Such a file contains the mandatory (technical) documentation with regard to the device. It also describes, among other things, which choices the researchers made to guarantee the safety and effectiveness of the product, for example in the design and manufacture. The file must therefore contain sufficient information about the medical device so that the members of the METC can assess the safety, clinical benefits, performance and quality of the medical device for investigation.
For scientists it means that it becomes more important to properly organize the technical documentation concerning risks and design choices during research and early development.
The group of researchers from Erasmus MC, LUMC and TU Delft has started working on the new requirements. Three pilot projects, part of the Medical Delta NIMIT scientific program, have been selected for this, namely:
These three medical devices technically range from moderately simple to moderately complex. Because they also differ in their development phase, the researchers are exploring whether thinking in terms of risks and documenting the design choices in the early research and development phase, contribute to better solutions.
The aim is to have an approved IMDD drawn up for every pilot project in 2021. Other objectives are to set up a clear process and to make toolkits available for subsequent Medical Delta researchers who offer sufficient support to arrive at an internally approved IMDD.
To this end, the pilot projects make use of a concept process and tools that have been developed within the NFU program. In addition, toolkits are available for preparing the documentation. These are the result of existing documentation from Erasmus MC and LUMC and have been translated (in concept) to the situation under the MDR. The three pilot projects that are currently running, will test whether these processes and toolkits can be applied in research practice and whether there are necessary and desirable additions and improvements. In addition, the projects investigate which general obligations apply to the various parties in the chain from design to application of the medical device, such as the additional obligations with regard to quality management systems. This also happens in connection with the NFU program.
With the various pilot projects, the researchers experience the challenges that exist and how scientists can best overcome them. These experiences are widely shared within Medical Delta, so that the ambition to bring innovative technology to the clinic can continue in accordance with the new MDR. By bringing together the knowledge and experience gained by Erasmus MC, LUMC and TU Delft in complying with the new regulation as much as possible, not every researcher has to reinvent the wheel.
In the coming months, Medical Delta will publish a trilogy in which the experience gained from each project is shared.