The requirements of the Medical Devices Ordinance (MedDO, SR 812.213) are not applicable to importers of combination products with authorisation for a ready-to-use medicinal product provided that there is no distribution of the medical device as a stand-alone product, i.e. the medical device components must be part of the authorisation application for a combination product.
However, where the product concerned is a medicinal product with a referenced medical device component – i.e. if the medical device is not co-packaged with but is specifically for use with this product – the requirements of the medical device legislation must be met in full.
In this second publication, Swissmedic provides prompt, practical answers to application-related questions arising from the legal framework of medical device and medicinal product legislation, in particular concerning the medical devices included in the packaging as mentioned. Swissmedic continues to monitor developments, including those in the EU, and reserves the right to specify practice in the future, in particular as regards validity, exceptional characteristics and specific content of the general safety and performance requirements.