Legal framework

The legal framework and guidelines for clinical research with a medical device are set forth in the Medical Device Decree (section 13) and the Active Implants Decree (section 7). The foundation for the above directives resides in European legislation, namely: the Medical Device Directive 93/42/EEC (Annex VII-2.2. and X) the Directive on Active Implantable Devices 90/385/EC (Annex 6 and 7).

The named decrees hold the manufacturer of the medical device in question to a number of obligations before the clinical trial may begin. One of the explicit conditions is the submission of a positive advice by an accredited MREC to the Health And Youth Care Inspectorate. This review therefore not only takes place on the basis of the Medical Research Involving Human Subjects Act but is also specifically prompted by the legislation regarding medical devices.

For the MRECs this means that the review of clinical research with a medical device is a task in th context of a legal obligation based on the Medical Device Decree. This only applies to clinical research with a medical device which must be reported to the Health And Youth Care Inspectorate.