A custom stimulator device is being made for our project which we will use to deliver transcranial electrical stimulation on human brains. The company is well-known and has years of experience with medical deivces, but this particular device is quite new and therefore has no standards or certificates yet.
So my question is which laws or regulations in general are there for using such an untested device on humans for research? Would it be enough for us to have ethics committee approval and subjects' written consent?
As long as you have no CE certification of the device it is needed to apply via the BFARM. There is a shortcut for a device without CE certificate if it can be classified as IIa according to ISO 13485. But it will still need a lot of documents, tests etc. Furthermore, with MDD it was possible to get all certificates and tests done for one physical device only which is then the only device used during the study. This costs several thousand euros depending on the test house.
https://www.bfarm.de/DE/Medizinprodukte/_FAQ/Klinische-Pruefungen/Antrag-auf-Befreiung-von-der-Genehmigungspflicht/faq-liste.html;jsessionid=1C62CA78857087B565AA5A9926ED9676.intranet662?nn=597826
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