How can the High-Performance Center provide support in the implementation of the MDR?
In September 2018, our High-Performance Center invited stakeholders from industry and professional associations in the biomedical engineering sector to a discussion forum dealing with the question “How to survive with the European MDR?” Experts exchanged information regarding the current state of MDR implementation and discussed its impact. Together with the participants of this event, we defined specific measures that could both relieve the current situation and restore confidence in the innovation hotspot Germany for the future. These measures include accelerated accreditation of notified bodies , correction of deadlines for manufacturers, development of implementation guides, introduction of special regulations for conformity assessment, and avoidance of trust-like structures.
With our professional expertise pooled in the High-Performance Center, we offer advanced professional training for executives and junior staff in biomedical engineering companies, especially on regulatory issues.
Precisely speaking, at Fraunhofer ITEM in particular we support clients in their MDR-compliant development of innovative medical devices or in making adjustments to existing products to achieve compliance with the new regulations. In a one-stop shop, we devise a risk management strategy according to the ISO 14971 standard, perform biological evaluation of the medical device as part of the risk management process, and offer relevant in-vitro and in-vivo tests from the ISO 10993 series of standards. Clinical assessment is performed primarily based on scientific literature and, if required, can be complemented by clinical testing. We can provide optimal support to medical device manufacturers, as we pool our expertise in medical devices with our long-term experience in chemical risk assessment, nanomaterials, and biocompatibility.