Medical Device Directive 93/42/EEC (MDD)
The Medical Device Directive (MDD) gives the essential requirments that are applicable for instruments, apparatus, appliances, materials or other articles to be used an human beings:
Directly;
diagnosis, prevention, monitoring, treatment or alleviation of disease
diagnosis, monitoring, treatment or alleviation of or compensation for an injury or handicap
investigation, replacement or modification of the anatomy or of a physiological process
contraception
Indirectly;
Devices which do not achieve their principally intended action in or on the human body by pharmacological, immunological or metabolic means.
All products within the above scope are analyzed and classified according to risk. To gain access to the European market they must meet the requirements of the MDD and manufacturers have to follow the specified conformity assessment procedure. Compliance of products with the MDD has to be indicated by the CE-marking.
After a transition period of 5 years the MDD became mandatory on June 14, 1998.
Medical products not within the scope of the MDD may be covered by other medical directives, such as:
AIMD(90/385/EEC) Active Implantable Medical device Directive (mandatory since 01.01.1995)
IVD(98/79/EEC) In-Vitro-Diagnostic-Device Directive (start of the transition period: 01.01.1999)
For most medical products, as specified in the MDD, a Notified Body has to be involved during the conformity assessment procedure. Notified Bodies must meet the requirements of Annex XI of the MDD and must be notified by the European Commission.
TUV Rheinland Product Safety GmbH is accredited, fulfills the requirements of Annex XI of the MDD and is notified by the European Commission with registration No. 0197.