The Directive: MDD 93/42/EEC

The Directive: MDD 93/42/EEC

MDD 93/42/EEC (Medical Device Directive) has been in place since June 14, 1998. It was amended on September 5, 2007.  The consolidated directive became mandatory on March 21, 2010. The  directive establishes essential requirements and harmonized standards  for the manufacture, design, and packaging of medical devices. A medical  device is defined as any instrument, apparatus, appliance, software,  material or other article. This includes if this device is used alone or  in combination with software necessary for its proper application  intended by the manufacturer to be used for human beings in 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 achieve its principal  intended action by pharmacological process, immunological or metabolic  means but may be assisted in its function by such means.

The Medical Device Directive calls for all manufacturers who distribute in the European Economic Area to comply with essential requirements that benefit the safety of those  in the EEA. The devices must be designed and manufactured in such a way  that as they are used by patients, they will in no way compromise the  health of the patient. Other areas included and outlined in the  directive are requirements regarding design and construction, materials  used in the production of the device, and reduction of risk as far as  possible to the patient. The directive ensures that the performance of  the device promised by the manufacturer is achieved. The Medical Device  Directive is necessary due to the differences of safety, health  protection, and performance characteristics among Member States and thus  causes barriers to trade within the Community. The harmonized standards  of the Medical Device Directive allow for free movement within the  market.

The MDD 93/42/EEC has been amended in 2007. The 2007/47/EC  amendment was established on September 5, 2007 and the consolidated  directive became mandatory on March 21, 2010. The amendment is necessary  due to continual advancements in technology and development of  international initiatives. The Commission is to constantly analyze the  directives in order to ensure the protection of the patients. The  amendment has such changes as the definition of a medical device, things  which are not considered a medical device, explanation of Member  State’s role, etc.

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