Medical Devices
Definition
Medical devices are products with a medical purpose intended by the manufacturer for use on humans. Medical devices are also products that contain a substance or preparations of substances, or are coated with such, which when used separately would be considered a medicinal product or component 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 primary effect of medical devices is achieved primarily through physical means.
Medical Device Safety Officer
Medical Device Safety Officer at the Földi Clinic is
Dr. Regina Kluge
Medical Device Consultant at the Földi Clinic 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 January 1, 1995; it was most recently amended by Article 7 of the Law dated July 18, 2017
With the Medical Devices Act and the Medical Devices Regulation issued on its basis, the European directives on active implantable medical devices (90/385/EEC), on medical devices (93/42/EEC), and on in vitro diagnostics (98/79/EC) were implemented into national law. The purpose of this law is to regulate the trade in 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 particularly regulates the prerequisites for placing medical devices on the market and putting them into operation. In addition to implementing European law, the Medical Devices Act contains a series of national regulations, e.g., for conducting surveillance and for operating and using medical devices. Further details on establishing, operating, using, and maintaining medical devices are regulated by the Medical Devices Operator Ordinance.