Implementation of structures to observe the Law concerning medical devices (Medizinproduktegesetz / MPG ) and the Ordinance concerning the setting up, operation and application of medical devices (Verordnung über das Errichten, Betreiben und Anwenden von Medizinprodukten).

Since 1998 all medical devices distributed in Europe must bear the CE mark. The CE mark documents that the medical device has been manufactured in accordance with the Medical Device Directive and that a suitable conformity assessment procedure has been completed. In addition there are lots of other country specific regulations to be observed.
In brief the “essential requirements” state that safety and performance must be documented, and that potential side effects and risks must be described. The manufacturer must also have performed an analysis, showing that the benefits of the device are considered to outweigh the side effects.
The manufacturer’s internal control documentation in combination with a technical file and a declaration of conformity asserting that the device complies with the requirements, will normally be sufficient.
Technical specifications are to be found in standards. The so called Harmonised Standards have been developed by the Western European standardisation organisations CEN, CENELEC and ETSI on mandates of the EU Commission. Harmonised Standards are presumed to comply with the Essential Requirements in the directives.
The user of medical devices should make sure that he/she has qualifications and training in the proper use of the device, and is familiar with the indications, contra-indications and operating procedures recommended by the manufacturer. It is crucial that experience gained with medical devices be shared with other users, the vendor and manufacturer to prevent future problems.
This can be done by reporting any incidents to a coordinating centre from which warnings can be issued.
When using medical devices, users should always bear in mind that the safety and health of the patients are in their hands. The user has the responsibility to employ the medical device only for the intended indications (or to assure that any non-indicated use of the medical device does not compromise the safety of the patient and other users). The user also has the responsibility to ensure proper maintenance of medical devices during active use and safe disposal of obsolete medical devices (WHO 2003).

WHO 2003: World Health Organizations, Medical Device Regulations global overview and
guiding principles, Geneva 2003.
Medizinproduktegesetz 2003: Gesetz über Medizinprodukte (Medizinproduktegesetz) in der Fassung der Bekanntmachung vom 7. August 2002 (BGBl. I, S. 3146), geändert durch Art. 109 V vom 25.11.2003 (I2.03.04)
Gesetz zur Änderung 2007: Gesetz zur Änderung medizinprodukterechtlicher und anderer
Vorschriften, vom 14. Juni 2007 (BGBl. I Nr. 27 vom 20.07.2007)



In 2007 the Project group Clinical Activities implemented a database (inventory list; according to the Ordinance concerning the setting up, operation and application of medical devices) to list all active medical devices used in the divisions Medical Physics in Radiology and Radiology.