Kim, Check out http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/re flist.html
>From that page you can get to both the "In Vitro Diagnostic Medical Devices Directive" and the "Medical Devices Directive", as well as the Harmonised Standards for these Directives. It sounds like your product falls under the In Vitro Diagnostic Directive, but check the scope. As an accessory, your product still has to fully comply with the directive. Best Wishes, Jon Griver Medson Ltd. VP Quality Assurance email: [email protected] > Hi all > > Can some one give me links to information regarding EU Medical Devices > directive. > > My problem is to define the requirement for the following situation: > > A manufacturer is making an add-on device for another company's medical > device and the total equipment is CE approved without involving the > manufacturer. Now the manufacturer want to CE mark this add-on device and > sell it to other companies as a CE approved device still for medical > equipment. > > What is the requirements for this manufacturer, they have never been into > CE markin before. > > The equipment is used in laboratoriums to move small glases with different > materials for testing in another test device. > > best regards, > > Kim Jensen > > > ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected]
