Medical Devices
Definition
Medical devices are products intended for medical purposes, designed by the manufacturer for use on humans. Medical devices also include products that contain a substance or a mixture of substances, or are coated with such, which can be regarded as medicinal products or as components of a medicinal product (including plasma derivatives) that can exert an effect on the human body in addition to the intended functions of the product when used separately.
Unlike medicinal products, which act pharmacologically, immunologically, or metabolically, the primary intended action of medical devices is achieved primarily through physical means.
Safety Officer for Medical Devices
The Safety Officer for Medical Devices at Földiklinik is
Dr. Regina Kluge
The Medical Device Consultant at 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 force since 1 January 1995; it was last amended by Article 7 of the Act of 18 July 2017
amended. The Medical Devices Act and the Medical Devices Ordinance enacted on its basis have implemented European directives regarding active implantable medical devices (90/385/EEC), concerning medical devices (93/42/EEC), and regarding in vitro diagnostics (98/79/EC) into national law. The purpose of this law is to regulate the trade in medical devices, thereby ensuring 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 requirements for the placing on the market and the commissioning of medical devices. In addition to implementing European law, the Medical Devices Act contains a number of national regulations, e.g., for the conduct of monitoring and for operating and applying medical devices. Further details regarding the establishment, operation, application, and maintenance of medical devices are governed by the Medical Devices Operator Ordinance.