Postmarketing Surveillance Studies for the Generation of Clinical Evidence

Scientific postmarketing surveillance studies (PMS) are post-marketing non-interventional studies designed to further understand the benefit-risk profile of a product that has been tested in a clinical trial setting and is now in real clinical practice. The main objective of these studies is, in addition to scientifically motivated research, the collection of safety data, the optimisation of indications and the adaptation of the regulations for this product.

Scientific postmarketing surveillance is regulated according to the Professional Code of Conduct for Physicians, the Medicinal Products Act (AMG), the Medical Devices Act (MPG) and the Regulation (EU) 2017/745 on Medical Devices (EU MDR 2017/745).

 

You want to know which regulations apply to you and how to generate your clinical data? Please contact us.

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