Dear fellow list members, I would like some opinions on the scenario described below. This happens to be related to medical devices and specifically the MDD in the EU but I think the same scenario can be played out for any type of product governed by an EU CE Marking Directive
Background Info: - Device A is compliant to 2nd Ed of 60601-1 and has its own DoC. - Device A has been sold in the EU for years. - Device A is considered a medical device but is always used as part of a larger medical system, Deice B, which is also compliant to 60601-1 and has its own DoC. - Device A is discontinued and no longer produced and sold as a new product but still is produced only to replace defective units in the field that are used on Device B systems. Device A still bears CE Marking and has original DoC. - MDD will require all products "placed on the market" sometime after Jun-2012 (dependent on 60601-2-xx date in OJ) to be compliant to 3rd Ed of 60601-1. - New Approach Directive Guide indicates (2.1): "Products which have been repaired (for example following a defect), without changing the original performance, purpose or type, are not to be considered as new products according to New Approach directives. Thus, such products need not undergo conformity assessment, whether or not the original product was placed on the market before or after the directive entered into force. This applies even if the product has been temporarily exported to a third county for the repair operations. Such operations are often carried out by replacing a defective or worn item by a spare part, which either is identical, or at least similar, to the original spare part (for example modifications may have taken place due to technical progress, or discontinued production of the old part)." Scenario: - Device A fails in the field in the EU in 2013 and needs to be replaced (repair not possible). New identical replacement unit is manufactured and sent to the EU to replace defective unit. - The system (Device B) that Device A is used on in the field in the EU, is still 2nd Ed compliant. Questions: - Does Device A shipped in 2013, strictly to replace a defective identical unit, need to be compliant to 60601-1 3rd Ed? If so, why? - If not, should the device continue to bear the CE Marking and DoC to 2nd Ed even though the OJ will show 3rd Ed at this time? If not, will there be issues in customs with the device not bearing the CE Marking (i.e., should the packaging be clearly marked as for replacement use only?)? Regards, Nick Momcilovic Regulatory Engineering Leader GE Healthcare www.gehealthcare.com - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at: http://product-compliance.oc.ieee.org/ Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <emcp...@radiusnorth.net> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com>
