What are medical devices?
The number of medical devices on the European market is estimated at between 500,000 and a million, spread over a total of approximately 8,000 different kinds.
Medical devices include:
- Medical commodities such as dressing materials, syringes, ECGs etc.
- Medical aids for the disabled, such as wheelchairs.
- Medical equipment such as x-ray machines and ultra-sound machines etc.
- Active implants such as heart pacemakers etc.
- Non-active implants such as joint implants or bone screws, medical software such as medical expert systems.
- Medical laboratory diagnostics such as HIV tests or pregnancy tests.
- Medical laboratory equipment such as laboratory analysers etc.
Definition Medical Device
What is a medical device?
According to §2 paragraph 1 Medical Device Act (MPG):
„medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means”
What has to be done?
- reporting requirements / reports to BASG (according to §70 MPG)
- Post-Market-Surveillance system (according to subsection 4 Annex VII directive 93/42/EEC)
“The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase […] and to implement appropriate means to apply any necessary corrective actions […].”
Risk classes for medical devices
Medical devices are categorised into three distinct types:
•Active implantable medical devices.
•General medical devices.
•Medical devices for in-vitro diagnosis or in-vitro diagnostic medical devices.
Classes of general medical devices
General medical devices and in-vitro diagnostic medical devices are sub-divided into further risk classes, each dependent on the risk involved in usage or the risk to the patient.
For general medical devices, a differentiation is made between a total of four different risk classes depending on the risk to the user/patient, the level of invasiveness and the duration of use etc.:
• Class I medical devices: low risk.
• Class IIa medical devices: medium risk.
• Class IIb medical devices: increased risk.
• Class III medical devices: highest risk.
Classes of in-vitro diagnostic medical devices
In-vitro diagnostic (IVD) medical devices are also sub-divided into risk classes:
• General IVD: low risk for user/patient.
•IVD for self-diagnosis: medium risk.
• List B - IVD: increased risk.
• List A - IVD: highest risk.
Legal basis for medical devices
Created: 01.03.2009 | Page last modified: 20.10.2016