Medical Devices
Definition
Medical devices are products intended for medical purposes, which are designed by the manufacturer for use in humans. Medical devices also include products that contain a substance or preparations of substances, or are coated with such, which when used separately are considered as medicinal products or components of a medicinal product (including plasma derivatives) and can have an effect on the human body in addition to the functions of the product.
Unlike medicinal products that act pharmacologically, immunologically, or metabolically, the intended main effect of medical devices is primarily achieved through physical means.
Safety Officer for Medical Devices
The safety officer for medical devices at the Földiklinik is
Dr. Regina Kluge
The medical device consultant at the Földiklinik is
Mr. Christian Dickert
Address:
Földiklinik GmbH & Co. KG
Rößlehofweg 2-6
D - 79856 Hinterzarten
Phone: +49 (0)7652 - 124 – 0
Fax: +49 (0)7652 - 124 – 116
medizinprodukte@foeldiklinik.de
Medical Devices Act
The Medical Devices Act (MPG) has been in effect since 1 January 1995; it was last amended by Article 7 of the Act of 18 July 2017
It has been amended. The Medical Devices Act and the Medical Devices Regulation issued on its basis have implemented the European directives concerning active implantable medical devices (90/385/EEC), medical devices (93/42/EEC), and in-vitro diagnostic devices (98/79/EC) into national law. The purpose of this law is to regulate the circulation of medical devices and thereby ensure the safety, suitability, and performance of medical devices as well as the health and necessary protection of patients, users, and third parties.
The Medical Devices Act specifically regulates the conditions for placing medical devices on the market and for their commissioning. In addition to the implementation of European law, the Medical Devices Act contains a number of national provisions, e.g., regarding the conduct of monitoring and the operation and application of medical devices. Further details on the establishment, operation, application, and maintenance of medical devices are regulated by the Medical Devices Operators Regulation.