According to § 23b of the Medical Devices Act (MPG), there is an exception to the requirements of a clinical trial of a medical device (according to §§ 20 to 23a), as long as the corresponding medical device has the CE marking and a clinical study is conducted according to the intended purpose of the medical device without additional invasive or other stressful examinations. These studies can then be carried out, for example, in accordance with the medical professional code of conduct for physicians.
In such clinical studies, the product is tested according to the purpose defined by the manufacturer. In the literature, "invasive" means that an examination is carried out specifically for the purpose of the study, e.g. taking blood. Whether a clinical examination is burdensome must be weighed and assessed in each individual case on the basis of various factors and measures that have already been evaluated as such.
Clinical studies according to §23b MPG are not explicitly regulated in MDR 2017/745, which also applies to clinical studies for medical devices. In Germany, these studies will continue to be regulated under national law in the future. At present, there are no new regulations at the national level. (Information from a Notified Body in Germany, September 2019)
Such studies, which may include post-market clinical follow-up (PMCF, Annex XIV) or post-market surveillance (PMS, Article 83) under the above conditions, shall in principle be designed, planned and conducted in strict compliance with good clinical (ICH-GCP) and scientific practice, in accordance with the professional code of conduct for physicians and other applicable laws, regulations and standards.
However, "incidents" in such a study must be reported by the manufacturer, i.e. the sponsor of the study, to the authority from January 2020 on a "Manufacturer Incident Report for Serious Incidents and Incidents". This also applies to studies that have already begun.
This allows the effect, benefit, side effects and safety to be demonstrated and proven.