Medical device manufacturers

A medical device is an object or material that is used for medical, therapeutic, or diagnostic purposes, whereas the principal intended action differs from drugs and is not primarily a pharmacological, metabolic, or immunological but a physical and physicochemical one.

The differentiation between drugs and medical devices is crucial as market access and marketability are regulated in a very different way. In Germany, the Medical Devices Act (Medizinproduktegesetzt, MPG) from August 2, 1994 governs medical devices. It is used for the national implementation of three European (key) directives (90/385/EEC [Active implantable medical devices], 93/42/EEC [Other medical devices], and 98/79/EC [In vitro diagnostics]), having been amended or modified by amending directives, and finally by the directive 2007/47/EC from September 5, 2007 on March 21, 2010.

The MPG and its eight executing statutory instruments include, furthermore, other national regulations mainly for the monitoring of medical devices on the market (market monitoring). The MPG was last amended on July 30, 2010. Medical devices in the scope of the directive 93/42/EEC are single or connectively used instruments, systems, appliances, software, material, or other objects, including the software that is especially applied for diagnostic and/or therapeutic use and for a proper functioning medical device by the manufacturer, and destined by the manufacturer for use on patients for the following purposes:

– Recognition, prevention, monitoring, treatment, or relief of diseases;
– Recognition, monitoring, treatment, relief or compensation of injuries or handicaps;
– Examination, replacement, or modification of the anatomic structure or of a physiological procedure;
– Contraception.

It has its principal intended action within or on the human body and this is not achieved by pharmacological or immunological agents or in a metabolic way, but its action can be supported by those agents. Medical device accessories are objects that are not a medical device but are especially intended by the manufacturer for use “in combination with a medical device” so that it can be used in accordance with the use of the device intended by the manufacturer of the medical device. In vitro diagnostics are also medical devices (§ 3 No. 4 MPG).

An “active medical device” is any medical device operation that depends on a source of electrical energy or any source of power (other than that directly generated by the human body or gravity) and that acts by converting this energy. A device intended to transfer mainly unchanged energy, substances, or parameters between an active medical device and the patient is not considered as an active medical device. In line with medical technology, different products from different surgical, diagnostic, imaging technology, sterilization, and therapy applications are used for the treatment of chronic venous diseases. Phlebology is often only a niche market. For this reason, it is our task to identify technologies from related disciplines and to test them in regard to market opportunities. We operate in fields such as technology scouting and scientific product placement as well as marketing.