Medizinprod93 / 42 / EWG – CE certification for medical devices MDD
Council Directive 93/42 / EEC of June 14, 1993 on medical devices is one of a total of three EU medical device directives and is referred to as the medical device directive for short in Germany and Austria. Internationally, the directive is referred to as the Medical Device Directive (MDD), or Directive 93/42 / EEC.
It is the most important regulatory instrument for proving the safety and the medical-technical performance of medical devices in the European Economic Area. It was last modified in large parts in 2007 via the amending directive 2007/47 / EC. These changes became legally effective in the EU on March 21, 2010.
The new regulation (EU) 2017/745 on medical devices came into force on May 25, 2017. This is also known as the Medical Device Regulation (MDR) and is valid without being implemented in national laws. With a transition period of 3 years, it will replace the Medical Device Directive 93/42 / EEC from May 26, 2020.
As with all European directives, the primary goal of the Medical Devices Directive is to enable the free movement of goods.
Medical devices in the sense of the directive with regard to the CE marking
Medical devices are all instruments, apparatus, devices, substances or other objects used individually or in combination, including the software used for the proper functioning of the medical device, which are intended by the manufacturer for human use for the following purposes:
Detecting, preventing, monitoring, treating or alleviating disease;
Detecting, monitoring, treating, alleviating, or compensating for any injury or disability;
Investigation, replacement or modification of the anatomical structure or a physiological process;
and whose intended main effect in or on the human body is achieved neither by pharmacological or immunological agents nor metabolically, but whose mode of action can be supported by such agents. For the purposes of this guideline, accessories are treated as an independent medical product; other articles that are defined as medical devices are:
Custom-made products according to medical specifications for certain patients,
products intended for clinical trials on humans.