Medical devices are classified into risk classes (I, Im, Is, Ir, IIa, IIb, III).
The higher the risk class, the higher the risk posed by the device to patients, users, the environment and third parties.
In Annex VIII of the Medical Device Regulation - MDR 745/2017 - classification rules are defined, which must be analyzed based on the medical purpose of the medical device. The result is one of the above mentioned risk classes, which has to be assigned to the medical device.
In the case of MEDUSA, a neurosurgical simulator that has no direct patient contact, it is not immediately obvious which classification rule applies.
The decisive factor is the information provided by the training platform, how this information has to be interpreted by the user, and whether or not diagnostic and/or therapeutic decision support is given on the basis of the information provided.
The current development status of MEDUSA leads us to risk class I, meaning that future manufacturers will not need a Notified Body for the approval process.
Regardless of whether Class I or higher, the technical documentation required by the Regulation (MDR, Annex II and Annex III) and the associated proof of compliance with the essential safety and performance requirements (MDR, Annex I) must be implemented.
The realization of this regulatory required documentation is currently a central of the research project MEDUSA.
The most important work packages in this field include:
- Analysis of the regulatory framework relevant for the neurosurgical training platform.
- Development of the risk management process according to EN 14971
- Usability engineering according to EN 62366
- Documentation of software development according to EN 62304
- Analysis of the biocompatibility of the materials used
- Establishment of a quality management system according to EN 13485