Medical Device Ordinance
| Basic data | |
|---|---|
| Title: | Ordinance on the safety of medical-technical devices |
| Short title: | Medical Device Ordinance |
| Abbreviation: | MedGV |
| Type: | Federal Ordinance |
| Scope: | Federal Republic of Germany |
| Issued on the basis of: | § 24 GewO , § 8a GSG |
| Legal matter: | Special administrative law |
| References : | 7102-44 a. F. |
| Issued on: | January 14, 1985 ( Federal Law Gazette I p. 93 ) |
| Entry into force on: | predominantly January 1, 1986 |
| Last change by: | § 16 VO of June 29, 1998 ( Federal Law Gazette I p. 1762, 1767 ) |
| Effective date of the last change: |
July 7, 1998 (§ 18 VO of June 29, 1998) |
| Expiry: | January 1, 2002 (Art. 6 G of December 13, 2001, Federal Law Gazette I p. 3586, 3603 ) |
| Please note the note on the applicable legal version. | |
The Medical Devices Ordinance (abbreviation: MedGV, long title: Ordinance on the safety of medical-technical devices ) came into force in Germany on January 14, 1985. In it, the medical-technical devices known at the time were divided into groups according to their degree of risk for the patient. The Medical Devices Ordinance governed the handling of medical devices until January 1, 2002 and was replaced by the Medical Devices Act.
background
At the beginning of the eighties, the level of technology in German hospitals rose by leaps and bounds. Medical-technical devices for diagnosis and therapy, which previously could only be found in university hospitals, have become affordable for all hospitals thanks to the development of integrated circuits. The training of doctors and nurses at that time contained almost no physical-technical aspects. Incidents caused by incorrect operation of medical-technical devices, in which the patient's state of health seriously deteriorated. Defective devices were also used on patients because the users were not aware of the technical dangers. To counteract this, a regulation on the safety of medical-technical devices was drafted.
content
Devices with a high degree of danger such as defibrillators were assigned to group 1. These were named in Appendix 1 of the ordinance.
For the safety of patients , it was stipulated that only personnel who have been instructed in how to use them are allowed to operate energetically operated devices. Devices of group 1 also had to be checked by trained inspectors in accordance with the deadlines specified in their type approval and the keeping of a device book with all documents about maintenance, tests, repairs and instructions on correct handling was prescribed for these devices.
The manufacturers had to have devices in group 1 subjected to a type test by a notified body before they were allowed to sell them in Germany. A major weakness of the MedGV was that the list of safety-relevant devices in Appendix 1 was never expanded. Subsequently developed devices with the same degree of risk, e.g. B. intracardiac heart-time-volume measuring devices were not covered by the regulation and could therefore be operated with lower requirements.
