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.
- Technical File
- Notified Body under the MDD
- Authorized Representatives under the MDD
- Custom Made Medical Devices
- Clinical Investigation
- Risks of Non-Compliance
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