Senest opdateret: 13.02.2009
Medicinal devices are devices for examination, monitoring, treatment or relief of disease in humans, e.g.: syringes, surgical equipment, hospital beds, pacemakers, hip replacement implants, crutches, or condoms.
Effective from 1st January 2006, the Danish Medicines Agency is to weigh the technical/professional evaluation of clinical testings of medicinal devices, whereas the regional committee on biomedical research ethics is to make the biomedical research-ethical evaluation of the trial.
Clinical testings of medicinal devices are trials on humans that will test the safety or performance of the devices. Clinical testings of medicinal devices, regardless of whether they are provided with CE marks or not, must be notified to a regional research ethics committee.
The notification to the research ethics committee shall meet the requirements stated in Guidelines about notification of a biomedical research project (2008) to the committee system on biomedical research ethics.