93/42/EEC: Medical Device Directive, as amended by 2007/47/EC.
The main idea behind CE marking products distributed in Europe is to reduce trade barriers between member states of the European Union. The medical device directive provides the uniform requirements regarding the health and safety of persons working with or who are in contact with or in the vicinity of the devices. Medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels that the manufaturer attributes to them.
CE is an abbreviation for "Communautés Européennes" (European Communities). Application of the CE Mark shows that the manufacturer has submitted a declaration of conformity with the essential requirements for medical devices, and, in the case of potentially dangerous devices, that the devices complies with the applicable "harmonized" standards (standards that have been harmonized between the member states) or that a notified body has conducted an EC type examination on the devices.
Conformity to the essential requirements must be proven, and a risk assessment is required. A technical file or, in the case of potentally dangerous devices, a design dossier is compiled.
SHEQ Management Systems consults to organizations regarding conformance to the requirements of the medical device directive (MDD). We ensure that the process is streamlined, by providing training, advice on the requirements of the directive (legal and technical), assisting with the risk assessment and risk management, as well as with drawing up the declaration of conformity. A full documentation pack is delivered, including all the required documents.
The South African government envisages that, within the next few years, the requirements of the MDD will become mandatory for South African manufacturers of medical devices as well (for regulatory purposes). This legislation has not yet been promulgated.
Also note that often the requirements of other directives, such as the Low Voltage Directive (2006/95/EC), the Electromagnetic Compatibility Directive (2004/108/EC), etc may also be applicable.
For further information and to find out how SHEQ Management Systems can assist you in this regard, please contact us
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