Within the Medical Device Directive, 93/42/EEC, Annex VII it states as: "The manufacturer must prepare the technical documentation described in Section 3 (TDF). The manufacturer or his authorized representative established within the community must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured."
It seems it can be either one. However - our Authorized Representative has requested a copy of our technical documentation file and we obliged. There is also a similar requirement in Article 10 of the EMC Directive 89/336/EEC. Hope this helps. -----Original Message----- From: Stafford, Jim [mailto:[email protected]] Sent: Wednesday, March 01, 2000 1:50 PM To: IEEE EMC BB Subject: RE: Techinical Documentation a couple of questions to round out this thread. Let me start off with definitions TCF : document for "type" approval by competent body Technical documentation file (TDF): manufacturer's documentation that show conformity with essential requirements. 1) Can either of the these files mentioned above (which depends upon the certification route) be held by a foreign manufacturer (non-EC member) or do they need to be held within the community by authorized representative? 2) Does this vary depending upon the directive(s) to which conformity is being shown? jim stafford carrier access corporation [email protected] ------------------------------------------- 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] ------------------------------------------- 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]
