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Session: Medical devices & safety
Session starts: Thursday 24 January, 10:30
Presentation starts: 11:30
Room: Lecture room 535

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Herke Jan Noordmans (University Medical Center Utrecht)

Abstract:
The new medical device regulation sets additional requirements not only for manufacturers and suppliers but also for healthcare institutions. In the Netherlands, we started from the Dutch Association of Clinical Physics, in consultation with adjoining professional associations, to define a uniform route how to deal with issues related to CE / non-CE status of medical devices or whether it is used within intended use. In this route it is agreed under which circumstances a medical device may be used (regular care, medical research, unique patient, or self-development without alternative). In this route the Medical Device File (MDF) is an essential element to record the design, develop, tests, use and their associated risks. Within this route it is also proposed who or which committee should assess this file at which stage in the route. The CE route is followed by the regular Convenant Medical Technology process. Risks from the CE process should be included or mitigated in this convenant process. Through this CE route we want to clarify for manufacturers outside a hospital but also for self-developed tools within a healthcare institution how to deal with issues around CE. In this way we hope to maximize both quality and safety without losing too much time in bureaucracy due to lack of clarity of procedures or duplication of information within documents.