Abstract :
Now a day’s medical devices are being used at greater extent in many countries. Medical devices are marketed according to the compliance with the requirements of various regulatory bodies. For commercialization of medical devices in the European Union, a CE Mark certificate is needed. CEis a "European Conformity" is the translation of the French term "Conformité Européenne". It also significantly reduces the time and resources need to compile application for registration, easy in the self-declaration for medical devices, simplifies exchange of regulatory information between regulatory authorities and playing field good for export market CE marking is the medical device manufacturer’s claim that product meet all regulatory requirements for all relevant European Medical Device Directives. The CE mark is a legal requirement to place a device on the market in the EU. The intension of this presentation is to know about the regulatory requirements and to analyze the requirements for obtaining CE marking for medical devices and simplifying CE marking procedures for various medical devices. It is given based on the description of research design. The marking certification process undergoes six steps to affix the CE mark. At present system Notified bodies issues CE certificates valid for 3 years. For some High — risk devices validity period may only one year. However, the status of your CE certification is dependent on maintaining your quality system certification.
Keyword :
Medical devices, Technical file, Combination products, IVD selfcertified devices, Quality