Members can access private content by clicking here.
Medical devices are defined as any healthcare products that do not achieve their principal intended purpose by chemical action or by being metabolized. This definition encompasses products that vary greatly in their complexity, purpose and mode of action. It includes simple crutches as well as complex diagnosis devices such as endoscopy capsules. From a regulatory point of view, the development of medical devices is different from that of drugs, e.g. the market authorization for devices is delivered by country Notified Bodies through the CE mark, while it is delivered by the EMA in the case of drug products through the ICH guidelines.
All the specificities related to the medical device industry led to the launch of the Special Interest Group (SIG) on Medical Device in 2010. The purpose of this SIG is to provide a discussion platform for statisticians working in the Medical Device industry and to address specific needs in this field. The main aims of the group are the following:
- To create visibility on biostatistics activities for medical devices,
- To strengthen methodological aspects in the development of medical devices,
- To create an expert group identified by authorities,
- To share Good Statistical Practice.