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New Medical Devices Directive 2007/47/ECFriday 12th February 2010 The Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC) are both being amended by a NEW Medical Devices Directive (2007/47/EC). The changes concern, among others, the essential requirements which medical devices must satisfy in order to be placed on the market, the corresponding conformity assessment procedures and the classification of devices. The new Directive was published on the 21 September 2007 and shall apply from the 21st March 2010. Just some of the changes include; the Active Implantable Medical Devices Directive being more coherent with the 93/42/EEC (Medical Devices Directive); all devices now require clinical data, including Class I Devices, with more stringent requirements as to what constitutes as “clinical evidence;” custom devices will now require a post-market surveillance system that is reportable to the Competent Authorities; ergonomics (“human factors”) are now considered to be a key factor, both in terms of the essential requirements and in terms of labelling. There is also no transitional period between the Directives and manufacturers are not obliged to comply with the new requirements prior to the 21st March, however they may do so on a voluntary basis. Is it important to act as soon as possible to ensure that your medical device complies with the new Directive. If you need any assistance with the new Directive then please contact the CE Marking Association on 01527 595066.
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