Since the 14th June of 1998 each medical device must carry a CE mark. A pre-condition of this is a conformity assessment porcedure which reviews product compliance with the general requirements of the directive. Respective to the risk class of the device, there are varying procedures that can be applied. In this respect, it is not important whether a device has been produced within the EU or imported from any country outside the EU. The involvment of a Notified Body is necessary for all medical devices, except for class I medical devices (non-sterile or without a measuring funtion).

Scope

The Directive 93/42/EEC applies for the placing on the market and launching of medical devices and their accessories. Product placement on the market cannot be prevented by any EU country if a device caries a CE mark which is a confirmation that this device meets the basic requirements according to Annex 3. Directive and has undergone the conformity assessment procedures. If this is not the case, the product placement on the market can be prohibited.

Medical Device Directive (MDD) gives the essential requirements that are applicable for instruments, apparatus, appliances, materials or other articles used by people for the purpose of:

• Diagnosis, prevention, monitoring, treatment or the alleviation of disease
• Diagnosis, monitoring, treatment or the alleviation of or compensation for an injury or handicap
• Investigation, replacement or modification of the anatomy or of a physiological process
• Contraception

and which do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means, although they may be assisted in their function by such means. Software installed for the full functioning of a medical device is also included.

Further to this, the Medical Device Directive 93/42/EEC is also applicable for accessories of medical devices. These accessories are such objects which are themsleves no device, but according to the manufacturer, have a fixed purpose in connection with the device. These are, for example, additional equipment or single-use devices. Also once-only custom-made devices for named patients and for clinical trials of certain devices are subject of the directive without the carrying of the CE marking.

This Directive does not apply to the following products:

• AIMD - Active Implantable Medical Device Directive 90/385/EEC
• IVD - In-Vitro-Diagnostic-Device Directive 98/79/EC
• Medicines Directive in terms of Directive 65/65/EEC
• Cosmetic agents in terms of Directive 76/768/EEC
• Human blood, products from human blood, human plasma or blood cells humans origin and related devices that contain them (Directive 2000/70/EC) apart from "derivates" from human blood
• Grafts as well as tissues or cells of human origin and related products that consist of them or have been extracted from them
• Personal protective equipment in terms of Directive 89/686/EEC